ASSOCIATE PRINCIPAL SCIENTIST JOB DESCRIPTION

An Associate Principal Scientist who leaves a program without a clear model-based dose rationale forces clinical teams to revisit decisions that should have been locked months earlier. This role owns the scientific judgment at the center of drug development programs - designing experiments, synthesizing evidence, and translating preclinical and clinical data into decisions that move candidates toward IND filing or regulatory submission. Within a matrixed research organization, the position spans early discovery through late-stage development, interfacing with CRO partners, cross-functional project teams, and regulatory bodies. What makes it demanding is the expectation to function as both bench-level expert and strategic voice - the kind of scientist who shapes a program, not just executes within one.

As the Associate Principal Scientist, you will drive the scientific strategy and experimental execution that advance drug candidates through preclinical and clinical development, from target validation and assay design to regulatory document authorship and go/no-go recommendations. You will work within a cross-functional research team, partnering with CROs, translational medicine functions, and program leadership to deliver evidence that informs portfolio decisions.

Career Impact: Authoring INDs, CSRs, and IND/IMPD summaries at this level establishes a track record that carries weight with regulatory agencies and opens doors to Principal Scientist and Associate Director roles.

Business Impact: The experimental findings and model-based analyses this role produces determine which drug candidates advance, directly shaping the pipeline that reaches patients.

Growth Opportunity: Regular representation at regulatory meetings and scientific conferences, combined with supervisory responsibility for junior scientists, accelerates the shift from individual contributor to recognized program leader.

• Lead experimental design and execution across in vitro and in vivo studies to identify, validate, and characterize novel drug candidates.
• Drive model-based analyses including population PK/PD modeling, exposure-response analyses, and clinical trial simulations to inform dose selection and program strategy.
• Author and contribute to regulatory submissions including INDs, IND/IMPD summaries, CSRs, and briefing documents for health authority interactions.
• Manage CRO relationships covering study design, monitoring, data review, and scientific interpretation of outsourced preclinical and clinical work.
• Develop and validate fit-for-purpose assay formats including multi-cell systems, primary immune cell models, and high-throughput screening platforms.
• Represent the function on cross-functional project teams, independently developing and communicating biological or pharmacological strategy for assigned programs.
• Mentor and guide junior scientists and research associates, setting clear priorities and supporting their technical development.
• Monitor the external scientific landscape through publications and conference attendance to identify emerging methodologies relevant to program needs.

• Ph.D. in pharmacology, biochemistry, biology, pharmaceutical sciences, immunology, or a related life sciences discipline, or equivalent work experience.
• Five or more years of drug discovery or development experience, with demonstrated progression from experimental execution to program-level scientific ownership.
• Proven track record of contributing to IND filings or equivalent regulatory submissions in an industry setting.
• Experience managing or directing work performed at CROs, including study design oversight and data interpretation.
• Proficiency in designing and executing complex biological or biochemical assays, including cell-based and in vivo model systems.
• Ability to synthesize multidisciplinary datasets and communicate findings clearly to scientific and non-scientific stakeholders in written and oral formats.
• Demonstrated ability to manage multiple concurrent projects and lead cross-functional scientific discussions independently.
• Record of peer-reviewed publications or IP contributions reflecting independent scientific contribution.

• Postdoctoral research experience in a drug discovery or translational research environment, particularly with biologic modalities such as antibodies, cell therapies, or oligonucleotides.
• Background in quantitative modeling approaches including PBPK, pharmacometric analysis, or exposure-response modeling relevant to regulatory submissions.
• Experience with GCP, GCLP, or cGMP operating environments and familiarity with ICH guidelines governing preclinical safety or clinical pharmacology studies.
• Prior supervisory responsibility for direct reports or matrixed junior scientists within a pharmaceutical or biotech research team.

• Number of IND or regulatory submissions contributed to per year, reflecting program advancement rate.
• Percentage of assay development milestones delivered on schedule within assigned programs.
• CRO study completion rate against agreed timelines, reflecting oversight rigor.
• Peer-reviewed publications or patent applications filed per two-year period, as a measure of independent scientific contribution.
• Proportion of program go/no-go decisions supported by data generated or synthesized by this role.
• Typical tools: pharmacometric modeling platforms (commonly NONMEM or Monolix); statistical computing environments (commonly R or SAS).

• Base Salary Range: $130,000 to $175,000 annually, depending on seniority and specialization.
• Bonus: 10% to 20% annual performance bonus typical at this level.
• Equity: Stock options or RSUs common at biotech and mid-size pharma employers.
• Health Benefits: Medical, dental, and vision coverage; FSA or HSA options standard.
• PTO: 15 to 20 days annually plus company holidays; some employers offer flexible PTO.
• Common Perks: Conference attendance and publication support; professional development stipend; relocation assistance for specialized roles.

Figures are estimates based on general US market benchmarks and may be outdated. Adjust based on location, company size, and seniority level.

Reasonable accommodations are available to applicants and employees with disabilities throughout the hiring process and in the course of employment, in accordance with the Americans with Disabilities Act and applicable state law. All qualified applicants will be considered for employment without regard to race, color, religion, sex, national origin, age, genetic information, veteran status, or any other characteristic protected under federal, state, or local law. Offers of employment are contingent on the successful completion of a background check. Candidates must be authorized to work in the United States without sponsorship now or in the future.

The Associate Principal Scientist leads the digitization of R&D technical documentation across Word, Excel, and local databases, serving as primary liaison between a global data transformation program, regional stakeholders, and IT partners to advance PepsiCo's specification management strategy. Working across SAP and ProductVision deployments, this role shapes data governance compliance, cutover planning, and end-to-end testing to ensure seamless migration to the SAP global specification system.

Key Responsibilities

• Serve as primary liaison between the global data transformation program, regional stakeholders, subject matter experts, and Information Technology partners to drive the digitization of R&D Technical documentation not currently in digital format, including Word, Excel, and local databases, consistent with people, process and technology strategy.
• Lead business, process, and technical discussions across stakeholders.
• Create frameworks around risk assessment in the context of R&D specification management to solve complex problems, address issues, and mitigate risks, including thorough vetting and presenting of options and robust impact analysis.
• Represent functional needs of key R&D stakeholder groups in the assessment, development, and implementation of current and future enhanced processes to enable use of new tools and protocols related to digitized specifications.
• Synthesize stakeholder perspectives and feedback clearly and actionably for cross-functional teams.
• Lead business scenario development for end-to-end testing across multiple deployments and provide input relative to R&D end user experience.
• Coordinate with data governance to ensure future processes comply with master data governance standards and collaborate with partner teams on compliance.
• Coordinate with Information Technology partners to represent R&D in creating strategy and evolving implementation approach across deployments, including agile coordination and cutover planning.
• Support data digitization team in identifying and documenting R&D specification processes as they transform from legacy to fully digitized specifications.
• Assist in sustaining the Intermediate Data Repository (IDR) to ensure seamless data migrations to SAP global specification system.

Required Qualifications

• Bachelor's degree in Food Engineering, Food Science, Biology, Information Management, or related field.
• Minimum three (3) years of experience in the job offered or a related role; three (3) years of experience in cross-functional business processes, data interactions, data relationships, and remediating affected data.
• Three (3) years of experience in project management including timeline development, milestone tracking, and risk and issue identification and mitigation.
• Three (3) years of experience tailoring business communication across regional or global stakeholders to drive common understanding of data in business and system contexts.
• Three (3) years of experience implementing large-scale data transformations globally across enterprise applications including SAP and ProductVision, and in executing change management and stakeholder engagement principles in a global program.
• Three (3) years of experience as a team lead managing direct and indirect reports, developing process and technical solutions, and creating strategic content for business and technical executives.
• Knowledge of data mapping, transformation, and loading concepts including AI, machine learning, and ETL.
• Experience with tools including Velox and Quickbase.
• Three (3) years of experience in R&D product development, processes, and supporting systems including specifications, document management, and workflows.
• Up to 10% travel (domestic and international) required; PepsiCo is an equal opportunity employer - Minorities/Females/Disability/Protected Veteran.

Reporting to the biologics leadership at Graphite Bio, the Associate Principal Scientist leads antibody engineering efforts spanning monoclonal antibodies, bispecifics, and antigen design to enable gene editing and hematopoietic stem cell therapies. Partnering with cross-functional teams across immunology, in vivo biology, stem cell biology, and gene therapy, this role delivers optimized protein candidates through CRO relationships and internal mammalian expression programs.

Primary Duties

• Provide technical expertise in antibody design including monoclonal antibodies, bispecifics, and fragments thereof.
• Lead optimization including affinity enhancement and Fc engineering for effector function and half-life.
• Develop and lead analytical assessment of protein purity, stability, and developability.
• Supervise mammalian expression and purification strategies for desired proteins.
• Lead the mammalian protein engineering function for multiple programs within a cross-functional team comprising immunology, in vivo biology, stem cell biology, and gene therapy disciplines.
• Train, manage, and mentor direct report(s) and manage outsourced research and CRO/CDMO relationships.
• Interpret and synthesize scientific data and communicate findings internally and externally, supporting regulatory submissions and intellectual property.
• Demonstrate excellence consistent with Graphite Bio's core values including scientific leadership and talent development.

Skills & Qualifications

• Ph.D. and post-doctoral studies in molecular biology, biochemistry, immunology, or related field with 3+ years of industry experience.
• Experience in industry drug discovery, especially with engineering antibodies and bispecific antibodies for therapeutic application.
• Ability to quickly learn new skills, demonstrate productivity, and deliver high-quality results in an open-ended, exploratory process.
• Entrepreneurial behaviors demonstrated by agility, accountability, transparency, resourcefulness, and ability to deliver results.
• Flexible mind with creative approach to problem solving and comfort working with ambiguous data.
• Exceptional communication and organizational skills with demonstrated ability to perform as a team player.

Sitting at the intersection of stem cell biology and immune cell therapy, the Associate Principal Scientist develops technologies for stem cell differentiation into functional T cells, deploying deep technical expertise to advance AstraZeneca's cell therapeutics pipeline. Operating across internal and external collaborations, this role influences program strategy, platform selection, and scientific visibility through publications and conference presentations.

Strategic Responsibilities

• Lead technology development for stem cell-based immune cell therapies.
• Represent BE on cross-functional teams accountable for delivery of new AstraZeneca cell therapeutics.
• Play a crucial role as both a functional expert and BE leader whose views directly influence discussions and decisions.
• Establish and lead internal and external collaborations to deliver new technology capabilities.
• Identify and lead strategic initiatives including new platform/project opportunities and improvements to ways of working.
• Drive external visibility of BE through publications and conference presentations.

Experience & Qualifications

• Ph.D. with 10+ years of extensive experience in a cell therapy discovery environment.
• Proven scientific track record of innovation and delivery within stem cell-based immune cell therapies.
• Track record of publications with iPSC/ESC/CAR-T and in establishing strategic planning for new technology development.
• In-depth knowledge of T cell biology/development and pluripotent stem cells.
• In vivo experience using mouse models and experience in other immune cell types such as macrophages and Treg cells.
• Extensive hands-on experience in pluripotent stem cell differentiation into functional T cells.
• Strong leadership and sound decision-making ability with demonstrated capacity to build and sustain relationships with scientific and leadership teams at local and remote sites.
• Stellar communication skills.

Embedded within the Quantitative Pharmacology and Pharmacometrics (QP2) function, the Associate Principal Scientist applies quantitative modeling to develop translational PK/PD strategies, characterize clinical pharmacokinetics and pharmacodynamics of new chemical entities and biologics, and inform dose selection and go/no-go decisions. Working closely with drug development teams and regulatory bodies, this role advances model-based strategies that directly shape clinical program outcomes.

Core Functions

• Serve as expert representative for QP2 on drug development teams.
• Frame critical drug development questions for optimizing model-based development.
• Develop and execute translational PK/PD models, population pharmacokinetic models, exposure-response analyses, clinical trial design and simulation, comparator modeling, and absorption/biopharmaceutical modeling.
• Maintain comprehensive understanding of global regulatory expectations for small molecules and biologics, including biopharmaceutic and life-cycle management strategies.
• Author regulatory documents (INDs, CSRs, CTDs), inform drug labeling, and represent QP2 at regulatory meetings.
• Mentor and/or supervise junior colleagues to perform and develop the above duties and capabilities.

Qualifications & Experience

• Ph.D. or equivalent with 3+ years, PharmD or equivalent with 5+ years, or MS or equivalent with 7+ years of experience in pharmaceutical drug development or academia.
• Educational background in biopharmaceutics, pharmaceutical sciences, pharmacometrics, mathematics, statistics/biostatistics, computational biology/chemistry, or related field.
• Exemplary record of increasing responsibility and demonstrated impact in driving drug development decisions through model-based approaches.
• Experience performing population PK/PKPD analyses using standard pharmacometric software (e.g., NONMEM, Monolix, Phoenix).
• Scientific understanding of biopharmaceutical and ADME properties of small molecules and/or biologics.
• Expert skills in experimental design, mathematical problem solving, critical data analysis/interpretation, and statistics.
• Proficiency in R, NONMEM, Matlab, or other similar programming languages.
• Proficiency in written and verbal communication, interdisciplinary collaboration, and problem scoping and planning.
• Demonstrated ability to lead an interdisciplinary team and oversee the work of other scientists.

A key member of the R&D PS&T team at Lonza Slough, the Associate Principal Scientist leads the development of small-scale and scale-down perfusion models as part of the N perfusion platform, bringing innovative upstream process development technologies into the organization. Collaborating across operations, junior scientists, and subject matter experts, this role defines critical knowledge areas that underpin next-generation platform perfusion process development.

Accountabilities

• Develop small scale and scale down perfusion models.
• Provide in-depth scientific leadership in a matrix environment to lead innovation upstream perfusion process development projects.
• Expand technical program understanding and participate in training of Operations team as required.
• Mentor and coach existing lab scientists and junior SMEs.
• Champion systems improvements by supporting process innovation and defining key knowledge areas critical to next generation platform perfusion process development.
• Maintain knowledge of the IP landscape.

Technical Qualifications

• BSc, MSc, or PhD in life sciences with relevant experience in the biopharma/biotech industry.
• Experience in small scale and scale down model development within mammalian cell culture.
• Knowledge and experience working within perfusion technology in a development setting desirable.
• Experience with a range of molecules (mAbs, complex proteins) desirable.
• Experience using a broad range of single use bioreactors and perfusion bioreactor processes.
• Research focus with knowledge of process development and upstream techniques applicable to pilot and manufacturing scale.
• Strong communication skills with demonstrated stakeholder management and ability to lead and collaborate on projects.

Sustained progress in neuroimmunology target discovery depends on the Associate Principal Scientist, who supervises the design, execution, and interpretation of experiments to identify and validate novel targets while integrating in vitro and in vivo approaches to drive program strategy. Based within the ESC portfolio team and managing relationships with internal therapeutic areas and external service providers, this role applies emerging methodologies in human disease modeling to advance neuroinflammatory research.

Leadership Responsibilities

• Contribute to and supervise the design, execution, interpretation, and communication of experiments to identify and validate novel targets in neuroimmunology.
• Integrate in vitro and in vivo approaches to drive program strategy.
• Apply knowledge of key signal transduction pathways to design appropriate experiments.
• Develop and manage project-specific milestones and timelines.
• Identify and apply emerging innovative methodologies to develop advanced fit-for-purpose in vitro models representing human disease pathology in neuroimmunology research.
• Manage R&D relationships with internal functional/therapeutic areas and external service providers.
• Communicate science and strategy to stakeholders and management.
• Stay informed of external scientific and technological innovations to enhance the ESC's project portfolio.
• Provide support, coaching, mentorship, and assistance to other team members.

Education & Experience

• Ph.D. in Neuroscience, Immunology, or cell biology with 5+ years of research experience.
• Prior experience in innate and/or adaptive immunity and its role in neuroinflammatory diseases.
• Broad knowledge of neuroimmunology.
• Practical experience with mammalian cell lines, primary immune cells, and complex multicellular systems.
• Ability to interpret and analyze data from biological, biochemical, and immunological assay systems and design appropriate follow-up experiments.
• Experience in high resolution microscopy and molecular biology.
• Ability to perform omics analysis.
• Experience leading projects to completion, managing multiple projects simultaneously, and managing other scientists.
• Excellent verbal, written, and record-keeping skills.

As the Associate Principal Scientist, this role drives the in vitro bioscience efforts within the early oncology unit, providing hands-on and strategic leadership across combination screening, novel model development, and technology evaluation. The early oncology team relies on this work to advance biological strategy for specific asset programs and deliver integrated in vitro capabilities that support in vivo and PDX collaboration.

What You'll Do

• Provide hands-on and strategic leadership to in vitro capabilities within bioscience.
• Work with internal project team members to prioritize, design, and interpret in vitro combination screens.
• Work alongside in vivo and PDX teams to support development of novel in vitro models including organoid and ex vivo platforms.
• Represent bioscience in cross-functional project teams and governance interactions, independently developing and delivering on biological strategy for a program.
• Evaluate emerging technologies to enable advanced capabilities within the combinations and screening teams.

Background & Experience

• Ph.D. with 5+ years of research experience in drug discovery and development with strong people and project leadership experience.
• Experience with in vitro biology including assay development and compound screening.
• Organoid model development and high throughput experience desirable.
• Demonstrated ability to work independently to design and conduct key experiments to support program progression.
• Ability to lead from the bench in problem solving and development of innovative solutions.
• Proven leadership skills, passion for mentorship, and consistent track record of working across boundaries to deliver common goals.
• Excellent communication and presentation skills.
• Proven track record of scientific publications in peer-reviewed journals.

Associate Principal Scientist leads the in vitro and in vivo biology effort across pre-clinical pipeline projects, focusing on the discovery and characterization of novel drug candidates for oncology and immunology indications. The work directly supports corporate partners and cross-functional project teams through assay development, data generation, and scientific communication from early discovery through IND filing.

Day-to-Day Responsibilities

• Maintain in-depth knowledge of drug discovery trends in the relevant field.
• Support assay development and execution on pipeline drug projects, both in vitro and in vivo.
• Execute experiments, generate and analyze data, and communicate results to scientific team and executive management.
• Lead and collaborate with other scientists and research associates to achieve company objectives.
• Record experimental details, maintain laboratory notebook, and comply with laboratory safety policies and practices.
• Attend appropriate external scientific meetings and present data where possible; draft scientific reports and prepare presentation slides.
• Supervise Research Associates and/or Associate Scientists as needed and cultivate positive working relationships with colleagues.

Professional Experience

• Ph.D. in Oncology or relevant discipline with a minimum of 3 years of drug discovery experience; pharmaceutical industry experience highly preferred.
• Experience in the drug development process from discovery through IND filing in an industry setting; experience working with CROs to effectively outsource research and development needs.
• Solid understanding of immunology and cancer cell biology.
• Experience establishing innovative assays including co-culture, human primary cells, phenotypic assays, and RT-PCR in high throughput format.
• Proven track record of publications in relevant fields.
• Creative, innovative, and inquisitive personality with strong leadership qualities; excellent communication and interpersonal skills.
• Ability to multitask, work independently, and collaborate effectively with local and cross-functional teams.

The Associate Principal Scientist produces consumer-relevant hair care solutions by translating beauty needs into technical problem statements and identifying knowledge-driven technologies across formulation, material sciences, and surfactant chemistry. Interacting with Domains of Invention, Product Evaluation Intelligence, Safety, Regulatory and Claims, and the IP and legal departments, this role advances the organization's competitive advantage through literature search, IP landscaping, and cross-functional innovation.

Scope of Work

• Translate consumer needs into technical problem statements and identify knowledge-driven technologies to address beauty aspirations and deliver consumer-perceivable benefits for hair care.
• Design and conduct experiments individually and with team to validate hypothesis and performance targets.
• Communicate results with clarity and recommendations in oral and written formats to both scientific and non-scientific audiences.
• Interact with various groups including Domains of Invention, Discovery Domain, Product Evaluation Intelligence, Development Domain, Safety, Regulatory and Claims to ensure new materials and composites meet broader priorities.
• Maintain external focus on new technology developments and conduct literature searches and IP landscaping to explore relevant applications and create competitive advantage.
• Participate in, lead, and generate new knowledge through discussions on hair science, new technologies, and formulations to strengthen overall knowledge of the field.

Minimum Qualifications

• Ph.D. in Chemistry, Material Sciences/Engineering, Chemical Engineering, Physical Sciences, or Biological Sciences.
• Master's degree with 7+ years of industry experience.
• Working knowledge of surfactants, hair structure, formulations, and material sciences with experience in problem definition and experimental design/execution.
• Experience in personal care industries is a plus.
• Well organized and flexible with ability to manage multiple projects simultaneously in a fast-paced environment while meeting deadlines.
• Demonstrated skills in analyzing, reporting, and documenting information with attention to detail.
• Excellent verbal, written, and interpersonal communication skills with high sensitivity to a diverse global culture; ability to work independently in a matrix environment.
• Must have authorization to work in the United States on a full-time, permanent, ongoing basis without need for sponsorship.

Reporting to the multidisciplinary research leadership at Simcyp, the Associate Principal Scientist undertakes novel research projects to expand the capabilities of the Simcyp Simulator while providing ongoing customer support, education, and workshop delivery to external users. Working closely with software developers and scientific meeting networks, this role advances IVIVE and PBPK modeling capabilities that inform drug metabolism and pharmacokinetic research globally.

Delivery Expectations

• Lead a team of scientists undertaking novel research projects to further expand the capabilities of the Simcyp Simulator.
• Provide ongoing customer support and education and training related to the use of the Simulators.
• Act as tutor and lead the workshop programme.
• Liaise effectively with software developers with high attention to detail.
• Attend scientific meetings as part of continuous education programs.

Knowledge Skills & Abilities

• Ph.D. or equivalent experience in a relevant field with several years of practical experience.
• Knowledge of in vitro assays used in drug metabolism and pharmacokinetic studies and their application in IVIVE approaches.
• Awareness of R&D process in pharmaceutical companies.
• Knowledge of PK/PD properties of small and/or large molecules.
• Experience in prediction of drug-drug interactions.
• Good understanding of modelling and simulation principles of physiological and biological systems and parameter estimation techniques.
• Track record of publications in peer-reviewed literature.
• Demonstrable communication skills as evident by presentation at scientific meetings, with good interpersonal and organizational skills.

Reporting to the Oral RHP pipeline leadership, the Associate Principal Scientist refines front-end innovation opportunities by assessing macro trends, consumer insights, and business objectives to identify and prioritize new oral reduced harm product concepts. Partnering with internal and external collaborators through design thinking workshops, prototyping, and CAD modeling, this role defines critical assumptions and key metrics that guide products through the full development lifecycle.

Job Functions

• Assess macro trends, industry data, consumer insights, and business objectives to identify new oral reduced harm product innovation opportunities.
• Frame, assess, and prioritize opportunities for inclusion in the Oral RHP pipeline.
• Use a variety of innovation methods including design thinking, lean start-up, ideation, and prototyping to turn opportunities into clearly articulated concepts.
• Design and facilitate collaborative innovation workshops for internal and external partners to conceptualize and develop new product concepts conveyed through visual thinking, storyboards, mock-ups, sketching, rendering, and CAD modeling.
• Identify critical assumptions pertaining to the desirability, feasibility, and viability of concepts and develop a learning agenda for further refinement and iteration.
• Identify key metrics for new concepts to be used as measures of success throughout the product development lifecycle.

Education & Experience

• Bachelor's degree in Product Design and Development or Innovation with 8+ years of relevant work experience required.
• Advanced degree or professional certification in a relevant subject area preferred.
• Experience leading Front End Innovation teams through product concepting.
• Experience working in the Consumer Packaged Goods industry preferred.
• Experience in Industrial Design and Design Thinking methods, processes, and tools.
• Proficient communicator and collaborator within Agile Team environments.
• Positive growth mindset, highly motivated, and able to work autonomously and in a group setting.
• General office, lab, and production environment requirements apply including safety equipment use and ability to travel up to 20%.

Sitting at the intersection of synthetic chemistry and translational drug discovery, the Associate Principal Scientist shapes hit-to-lead and lead optimization programs by designing innovative small molecules and applying state-of-the-art medicinal chemistry practice in close collaboration with computational chemistry and external CRO partners. Operating across multiple discovery programs, this role secures company IP through patent filing and builds a drug discovery platform capable of delivering clinical candidates.

Engineering Responsibilities

• Provide medicinal chemistry expertise in hit finding, hit-to-lead, and lead optimization phases in close collaboration with internal and external partners.
• Design innovative small molecules to enable rapid multi-parameter optimization of hits and leads with the ultimate goal of delivering clinical candidates.
• Apply state-of-the-art technology and current best practice in medicinal chemistry.
• Work closely with external chemistry CRO teams to synthesize and screen small molecules.
• Work collaboratively across scientific disciplines including computational chemistry on multiple projects.
• Perform IP analyses and secure company IP by patent filing.
• Help build and expand an innovative drug discovery platform.

Requirements

• Ph.D. and postdoctoral experience in Organic Chemistry with 7+ years of industry experience as a medicinal chemist.
• Demonstrated track record of advancing drug discovery programs from early discovery to IND filing.
• Experience managing, directing, and prioritizing work of remote teams of medicinal and synthetic chemists at CROs.
• Practiced in assessing the IP landscape and filing patent applications.
• Highly organized and detail-oriented.
• Proactive, forward-thinking, and strong team player with excellent communication skills.
• Fluent in written and spoken English.

A key member of the drug discovery research organization, the Associate Principal Scientist manages CROs, internal research programs, and a matrixed team to develop state-of-the-art multi-cell assay formats and identify novel targets and technologies. Collaborating with team members and leadership across therapeutic areas, this role advances oncology and immunology programs through advanced assay execution and biological insight.

Areas of Ownership

• Manage CROs and internal research programs.
• Identify and build novel assays and develop state-of-the-art multi-cell assay formats.
• Lead novel target/technology identification efforts.
• Manage a matrixed team and communicate findings with team members and leadership.
• Contribute to ongoing therapeutic program development through routine and advanced assay execution.

Position Requirements

• Ph.D. in biotechnology, biochemistry, biology, or pharmacology.
• Minimum 5 years of experience in biotech or industry with a proven track record of drug discovery experience and project leadership experience.
• Experience with culturing primary cells and cancerous cells.
• Experience running routine assays for development of a therapeutic; experience working with primary immune cells is a plus.
• Proficient in a range of molecular biology techniques including PCR, Western blotting, ELISAs, and FACS.
• Strong experimental design skills and ability to work independently in a highly flexible environment.

Successful scale-up and transfer of localized delivery technology manufacturing depends on the Associate Principal Scientist, who oversees process design, CMO management, and cGMP regulatory documentation while acting as liaison across the global Ascendis network. Serving as a technical lead within the process development organization in Redwood City, this role fosters cross-therapeutic collaborations and delivers the process controls, containment systems, and analytical support that move products from lab to commercial scale.

Ownership Areas

• Oversee the design, scale-up, and implementation of manufacturing processes, instruments, and equipment from laboratory through pilot and manufacturing scales.
• Act as liaison with research and/or development in the global Ascendis network to acquire and transfer product and process knowledge of the platform technology to new labs.
• Manage efforts at CMOs for GLP and GMP manufacture of development products and assist in authoring CMC regulatory filings and health authority interactions.
• Investigate novel processing options and execute experiments to select optimal equipment and processing strategies; aid in commissioning of processing labs for localized delivery and oncology.
• Oversee design and test containment systems to enable processing of highly potent compounds; generate development material in the lab as needed for in vitro and in vivo studies.
• Design and execute experiments to optimize and characterize key process operations and work with the analytical team on formulation, lyophilization, primary containers, and product assays.
• Develop in-process controls, create standard procedures, and provide process input in accordance with regulatory and quality requirements for cGMP process definition.
• Foster collaborations across Ascendis to provide development support in all therapeutic areas; establish and assure adherence to budgets, schedules, work plans, and performance requirements.

Qualifications & Experience

• Minimum Bachelor's degree (Master's preferred) in Chemical Engineering, Chemistry, Biochemistry, or related field.
• Minimum 10 years of experience in the Biotech or Pharmaceutical Industry, preferably in Process Development, Manufacturing Science and Technology, or Formulation/Analytical Development.
• Expertise in cGMP, regulatory and quality requirements of parenteral drug manufacturing; expertise in complex technology transfers; prior experience working with CMOs preferred.
• Experience with aseptic processing including drug delivery solutions, ADCs, polymer conjugates, novel technologies, and hydrogels; general knowledge of polymer-based drug delivery preferred.
• Strong hands-on expertise in process optimization, characterization, and development including drug product operations from early to commercial stage; experience in equipment design preferred.
• Proactive, collaborative communicator with solid understanding of drug development and ability to plan and conduct work with little guidance; strong team player thriving in global collaborations.
• Ability to travel up to 10–15% of the time domestically and internationally.

As the Associate Principal Scientist, this role leads the scientific contribution to the design, development, and lifecycle management of Medical Device software and Software as a Medical Device products, ensuring compliance with Design Control requirements and quality standards. The Pharmaceutical Technology and Development network relies on this work to deliver regulated digital therapeutics through risk assessment, international device standards, and mentorship of new team members.

Technical Responsibilities

• Provide technical leadership and mentorship for device deliverables of regulated digital therapeutics and other software device products developed for clinical evaluation, commercialisation, and lifecycle management.
• Collaborate with the Product Owner to lead device software aspects of development projects to achieve targets in a timely fashion; plan and review work to ensure objectives, timescales, and budgets are met.
• Lead specific device development activities and deliverables including risk assessments and design reviews, and prepare documentation ensuring compliance with quality and regulatory requirements.
• Demonstrate creativity and problem solving leading to broad business impact in the Software Medical Device area and maintain recognition internally and externally as a specialist in this field.
• Assess and report data with clear understanding of reliability, interpret findings, and draw authoritative conclusions; establish and maintain close working relationships with Product Owner, development partners, and suppliers.
• Maintain a network of contacts across Pharmaceutical Technology and Development and contribute to internal networks in the Device/Medical Device area.
• Contribute to training and development of new team members by acting as coach/mentor and provide disciplinary scientific leadership through patents, publications, and lectures.

Required Qualifications

• Degree and/or post-graduate qualification in a relevant subject.
• Experience working within a regulated software development lifecycle, ideally in a pharmaceutical or med-tech environment.
• Knowledge and experience of electronic/software-based medical device processes including quality management systems, design controls, risk management, software validation, and human factors.
• In-depth knowledge and application of international device standards (ISO 14971, IEC 62304, ISO 13485, IEC 60601) and awareness of the global regulatory landscape for software-based medical devices.
• Understanding and application of Agile software development methodology ideally in a medical device context.
• Excellent document writing and reviewing skills; experience preparing regulatory documentation in CTD format advantageous.

Associate Principal Scientist, Health Economics advances the strategic development and dissemination of global health economic models and tools that demonstrate product value to payers, HTA agencies, and healthcare decision makers. The work directly supports the CORE team under the Executive Director by generating evidence through real-world studies, cost-effectiveness analyses, and budget impact models that enable market access across US, Canada, and EU-5.

Executive Functions

• Provide strategic insights into the development and refinement of the integrated value evidence strategy and evidence generation from a health economics perspective.
• Develop and maintain global health economic models and tools in-house or in collaboration with external vendors, including epidemiology models, cost-effectiveness analyses, public health and budget impact analyses, and integrated field force tools.
• Collaborate with internal and external stakeholders to conduct evidence generation and synthesis studies to inform economic models and the value evidence strategy.
• Adapt and/or train global health economic resources for regional/local HEOR teams to support Health Technology Assessment submissions and market access activities.
• Disseminate health economic data via presentations at national/international congresses and publications in scientific journals.

Qualifications & Experience

• Doctoral degree or Master's degree in Health Economics, Biostatistics, Actuarial Sciences, or a related quantitatively oriented field.
• Minimum 3 years of experience in health economics and outcomes research (HEOR) in the pharmaceutical industry, consultancy, or relevant organisations.
• Experience in general medicine and/or antimicrobial therapies.
• Understanding of the market access environment and challenges in key markets including US, Canada, and/or EU-5.
• Strong track record of Health Technology Assessment submissions and development of health economic resources to support market access activities.
• Expertise and hands-on experience in conceptualisation, design, development, and dissemination of health economic models.
• Experience in evidence generation, synthesis, and analysis including real-world studies, literature research, and meta-analysis.
• Demonstrated strategic and innovative thinking.
• Excellent presentation, interpersonal, and networking skills to work effectively in cross-functional teams.

The Associate Principal Scientist creates and implements open-source software solutions for clinical trial design and analysis, coordinating methodology development across statistics and programming teams in a regulated pharmaceutical development environment. Collaborating with clinical trial teams, contractors, and junior staff, this role elevates analytical capability by delivering validated R packages, Shiny applications, and simulation tools that meet worldwide regulatory requirements.

Strategic Initiatives

• Develop, coordinate, and provide leadership for the development and implementation of open-source software projects in clinical trial design and analysis.
• Collaborate on and/or lead statistical research for clinical trial design and analysis.
• Consult with clinical trial teams to implement advanced design and analysis, and interact with contractors on significant outsourcing projects.
• Collaborate on internal standards development, training, and strategic planning for open-source software in a regulated pharmaceutical development environment.
• Work with statistics and programming teams to ensure underlying information technology supports advanced analytics application needs.
• Provide rapid response to implement/validate design, analysis, and simulation of clinical trials as needed; ensure all tools meet analysis requirements and regulatory standards.
• Prepare oral and written reports to communicate development needs and results to cross-functional teams and mentor junior staff in functional activities.

Skills & Qualifications

• Ph.D. or equivalent in statistics, biostatistics, computer science, data science, or related quantitative discipline with 3+ years of relevant experience.
• Master's degree with 6+ years of relevant experience.
• Understanding of worldwide regulatory requirements and clinical trial expertise.
• Strong project management skills.
• Development and design experience for substantial interactive applications (e.g., Shiny).
• Substantial experience developing and maintaining R packages; experience with R in a regulated environment.
• Experience in a Linux/Unix environment; exposure to other programming languages such as C++, SAS, or Python.
• Strong oral and written communication skills; proactive, motivated, and results-focused with a strong interest in statistical research; able to function effectively in a team environment.

Embedded within the MSAT function, the Associate Principal Scientist coordinates technical transfer of manufacturing processes from development through GMP manufacturing, representing MSAT across multiple customer product project teams handling both upstream and downstream operations. Working closely with subject matter experts, cross-functional colleagues, and external customers, this role guides root cause analysis, raw material introduction, and continuous improvement to deliver robust cGMP scale processes on time.

Project Responsibilities

• Represent MSAT within multiple customer product project teams to successfully transfer complex process stages into upstream or downstream operations from development through to GMP manufacturing.
• Be accountable for the identification and introduction of new raw materials for pilot and production scale batches, and for the management of technical risks associated with process transfer.
• Work cross-functionally to ensure transfer and communication of critical process and technical information so projects meet required deadlines and customer outcomes.
• Actively communicate with customers via face-to-face and teleconference and provide on-plant technical support.
• Lead root cause analysis (RCA) procedures to resolve manufacturing process issues and drive continuous improvements to the GMP process.
• Work with subject matter experts to develop knowledge base and deeper process understanding, and support junior team members on technical problem resolution.

Technical Qualifications

• BSc, MSc, or PhD in a science-related discipline.
• Proven experience in a drug substance environment with mammalian and/or microbial background; successful technical transfer expertise gained from a drug substance manufacturing environment.
• Recognized expert in USP and/or DSP drug substance operations from a cGMP environment; deep understanding of the manufacturing process as a whole.
• Strong knowledge in laboratory development and/or manufacturing operations background.
• Demonstrable experience in cross-functional project management and technical transfer activities with ability to multitask, prioritize, and make effective decisions.
• Strong interpersonal skills with ability to work cross-functionally with internal and external customers.

Reporting to the Biologics Discovery leadership, the Associate Principal Scientist executes phage display technology development, protein library generation, and lead optimization through protein and antibody engineering to develop the next generation of biologics across the company's Research Laboratories. Partnering with Biologics Discovery and Therapeutic Areas teams, this role elevates candidate quality through automation-driven screening, NGS-informed library design, and direct supervision of junior phage display scientists.

Core Responsibilities

• Isolate and optimize binding proteins using phage libraries and serve as subject matter expert within the laboratory.
• Supervise and mentor junior staff within the phage display group.
• Design strategy and generate highly diverse or optimized libraries to select binding proteins with desirable function.
• Execute experiments with automation methods using liquid handling equipment and manage data within the project.
• Collate and present results in team meetings and maintain a timely and accurate laboratory record of all activities.
• Work within a multidisciplinary and cross-functional team to advance biologics lead candidates.

Background & Experience

• Ph.D. with 5+ years of relevant experience in Biological Sciences (Molecular Biology, Structural Biology, Protein Biochemistry, Cell Biology, Biotechnology, or Bioengineering), preferably in an industry setting.
• MSc with significant relevant experience.
• Expertise with phage display for biologics generation and optimization.
• Experience using molecular biology to build libraries.
• Familiarity with yeast display, mammalian display, or other display methods.
• Familiarity with protein production and characterization.
• Understanding of protein structure-based drug design; experience with bioinformatics and Next Generation Sequencing (NGS) analysis.
• Proficiency in operating and method development in automation by programming liquid handling instruments; experience with high throughput molecular engineering.
• Experience supervising junior scientists; track record of scientific publications and/or IP generation.
• Strong analytical, problem-solving, teamworking, and communication skills.

Sitting at the intersection of translational medicine and preclinical safety, the Associate Principal Scientist manages CRO-based safety studies, performs mechanistic toxicology investigations, and contributes to regulatory documents including IND and IMPD summaries to characterize the safety profile of drug candidates in oncology and other therapeutic areas. Operating across Translational Medicine Project Teams and global programs, this role identifies early toxicology biomarkers that bridge preclinical findings to clinical safety decisions.

Role Responsibilities

• Perform safety profiling and participate in compound selection including on/off target toxicity assessment.
• Provide toxicological expertise to multidisciplinary teams and manage preclinical safety studies at CROs including design, monitoring, and reporting of safety findings.
• Contribute to the preparation of preclinical safety regulatory documents including IDB, summaries for IND and IMPD, and briefing documentation.
• Perform mechanistic studies on toxicology findings and identify early toxicology biomarkers for preclinical and clinical studies.
• Represent the Translational Preclinical Safety function in Translational Medicine Project Teams and global Team Projects.
• Participate in internal and external scientific communications including oral presentations, posters, and publications.

Qualifications & Experience

• University degree in Life Science; Ph.D. in a relevant expertise area or equivalent in biomedicine.
• 10 years of demonstrated experience in Toxicology/Preclinical Safety in drug development.
• Experience in the pharma industry with oncology experience an asset.
• Knowledge in preclinical research including animal and in vitro studies.
• Knowledge of GCP, GCLP, ICH guidelines, and animal welfare regulations.
• Good IT and analytical skills; project management experience a strong asset.
• Scientific rigor, curiosity, motivation, and excellent collaborative skills.
• Ability to influence through the matrix with demonstrated assertiveness and communication impact.
• Fluent in English.
• Ability to travel for study monitoring visits.