• Derive origins of process impurities and steps for control, mechanistic studies of reactions when needed, and actively work with contract research organizations on synthesis or isolation of process impurities.
• Represent process chemistry at CMC meetings to provide assessments, evaluations, status, issues, and other relevant technical aspects of the corresponding program.
• Author appropriate CMC sections to support regulatory (IND, IMPD, NDA) submissions.
• Act as the technical subject matter expert (SME) internally for troubleshooting process chemistry issues.
• Review and approve batch documents for drug substance manufacturing.
• Maintain process trend data to understand process changes.
• Interact with patent counsel in helping to draft patent applications for any new chemistry.
• Working with project teams to identify drug substance requirements, managing and optimizing aggressive project timelines, overseeing the development of technical solutions to ensure that API processes can be successfully demonstrated and delivered.
• Supervise, mentor, and guide direct reports (PR&D Senior Scientists, Scientists, and Associate Scientists) to enable them to be productive contributors and facilitate scientific and career growth.

Skills: Impurity Control, Mechanistic Reaction Analysis, CMC Representation, Regulatory Documentation, Process Troubleshooting, Data Trend Analysis, Patent Collaboration, Team Leadership and Mentorship

• Develop overall API strategy, timelines, budgets, risks & mitigations plans for all process development, starting materials, and manufacturing campaigns.
• Execute supply chain strategy for late stage (Phase 2 through NDA stage) clinical supply. 
• Lead process improvement and clinical batch manufacturing for various early to late stage API projects at the CMO.
• Actively manage development activities including scale up and technology transfer at the CMO.
• Develop a control strategy, process acceptance ranges, operating ranges, and documents in preparation for the validation campaign.
• Collaboratively worked with multiple groups within the organization to support the development of the API supply chain in preparation for the NDA and commercial launch.
• Select CMOs for project-specific activities. 
• Actively work with contract research organizations to develop robust and optimal critical unit aerations such as the crystallization process for the last synthetic step of the API as an example.
• Identify sources for starting materials and intermediates, and develop plans for consistent and continuous supply.
• Identify key process parameters and relevant in-process controls. 

Skills: API Strategy Development, Supply Chain Management, Process Improvement, Technology Transfer, Control Strategy Development, CMO Selection and Management, Crystallization Process Optimization, Starting Material Sourcing

• Plan and execute development strategies for the synthesis of active pharmaceutical ingredients
• Recruit and Lead the process chemistry group to design, demonstrate, optimize, and document chemical processes for small molecule drug candidates
• Select outsourcing partners, and help transfer and troubleshoot chemical processes to meet project goals and timelines
• Independently interpret data from internal efforts as well as outsourcing partners and present results and outcomes to diverse audiences, including senior management
• Collaborate with all research groups to design project timelines and generate materials in support of planned IND’s, and Clinical trials. 
• Planning and execution to deliver toxicology supplies, reference standards, impurity markers, and radiolabeled API 
• Collaborate with Formulations, Analytical and Supply Chain groups to design project timelines and generate materials in support of formulation development, clinical trials, and commercialization
• Assist with troubleshooting efforts in the commercial stage of projects, as well as, process scale-up and site transfers

Skills: API Development Strategy, Process Chemistry Leadership, Outsourcing Partner Management, Data Interpretation and Presentation, Cross-Functional Collaboration, IND and Clinical Trial Support, Supply Chain Coordination, Process Scale-Up and Troubleshooting

• Consult with clients on pre-approval and post-approval chemistry, manufacturing, and control (CMC) and Compliance aspects of small molecule and/or biologic products.
• Provide guidance and assistance to clients regarding strategies, research challenges, issues, concerns, and questions associated with the drug development process, CMC, and Compliance issues
• Interact with subject matter experts and regulatory authorities, as required on technical and/or regulatory matters. 
• Author and review regulatory documentation, primarily CMC documents, for INDs, NDAs, ANDAs, BLAs, Drug Master Files, and other global regulatory applications/submissions
• Serve as a principal spokesperson on significant matters related to the position’s oversight
• Manage departmental and project budgets appropriately
• Participate, with executive leadership, in the development and implementation of strategic business plans, decisions, and recommendations
• Remain accessible and coach employees when needed, maintain high levels of work and employee accountability

Skills: CMC Consulting, Regulatory Documentation Expertise, Drug Development Strategy, Regulatory Authority Interaction, Budget Management, Strategic Business Planning, Employee Coaching, Compliance Guidance

• Establish, manage, and oversee the CMC plan from pre-clinical through to registration studies
• Act as the CMC functional expert on projects
• Responsible for integration of clinical considerations in the development program plans that efficiently absorb risk in the advancement of therapeutic candidates
• Identify, manage, and oversee tech transfer processes, validation and all procedures related to the CMC component of the development plan
• Author and prepare documentation in relation to the CMC component of a regulatory dossier such as the Investigational Medicinal Product Dossier (IMPD), IND and NDAs and other documents 
• Develop the production plan to support the pre-clinical and clinical development plans
• Identification, selection, and oversight of external CMC service providers including, but not limited to, developing timelines, protocols, metrics, and budgets
• Identify emerging technologies and instrumentation and make appropriate recommendations for business application

Skills: CMC Strategy Development, Regulatory Documentation Preparation, Clinical Development Integration, Tech Transfer Management, Production Planning, External Service Provider Oversight, Emerging Technology Assessment, Risk Management in Drug Development

• Experience in building and managing a team of biochemistry/biophysicist scientists with diverse levels of experience
• Demonstrated ability to grow and develop the careers of team members
• An exemplary track record of impacting all stages of the drug discovery process through biochemical/biophysical experimental design
• Direct experience in working with and characterizing challenging proteins
• Self-motivated with high attention to details, ability to analyze, summarize and present data and significant conclusions to key stakeholders and decision-makers
• Good organizational skills with ability to work in a fast-paced team environment
• Proven success in building and leading high-performing, diverse, and inclusive teams
• The ability to communicate clearly and build open collaborative relationships 
• Ability to develop and/or direct the implementation of new and improved laboratory tests
• Ability to work effectively with junior, mid, and senior levels in the organization, as well as across teams and functions
• GLP study director or project management experience Chromatographic interpretation experience
• GLP experience 

Qualifications: BS in Biochemistry with 9 Years of Experience

• Drug substance development-related experience in pharmaceutical/biotech industry.
• Knowledge of drug substance CDMO landscape, ability to contribute to the identification and selection of CDMO partners, experience in negotiating the quotation/proposal process and establishing effective collaborations.
• A deep understanding of ICH and related drug substance related guidance to support the various development phases to filing and launch.
• Experience in late phase development activities, e.g scale-up and manufacture of drug substance for use in pivotal clinical trials, registration stability studies, and process validation.
• Experience authoring Initial New Drug Applications (IND), New Drug Applications (NDA) and responding to CMC questions from FDA/international regulatory authorities.
• Ability to work independently and as part of a team and maintain high ethical standards of integrity and quality.
• Ability to have an innovative and dynamic approach to work.
• A self-starter able to work independently but comfortable working in a team environment.
• Ability to consistently exhibit Supernus Values in interactions with employees at all levels of the organization, vendors, customers and others.
• Capable of performing other duties as assigned by Management.
• Ability to work independently and as part of a team, self-motivation, adaptability, and a positive attitude
• Ability to learn new techniques, perform multiple tasks simultaneously, keep accurate records, follow instructions, and comply with company policies
• Familiarity and/or experience in a laboratory setting

Qualifications: BS in Pharmaceutical Sciences with 15 Years of Experience

• In depth expertise in state of the art organic chemistry approaches, experience with synthesis of ionizable lipids and polymers
• Understanding of biodistribution and intracellular uptake parameters of receptor-targeted and systemic nucleic acid delivery modalities
• Experience with the design, production and characterization of encapsulated and conjugated delivery systems
• Experience developing technology platforms for therapeutic programs in industry
• Experience with developing strategic timelines and executing successful corporate goals
• Experience leading teams of Chemists
• Demonstrated ability in working with highly skilled teams in a fast-paced, entrepreneurial and technical environment
• Strong management experience and success in developing a scientific team and program
• Strong computer, scientific, and organizational skills
• Excellent communication (oral and written) and attention to detail

Qualifications: BS in Organic Chemistry with 8 Years of Experience

• Strong background and knowledge in Chemistry with a proven track record of drug discovery
• Experience with structure-based drug design
• A good understanding of biology and pharmacology strongly desired
• Demonstrates leadership capabilities, including effective cross-organizational skills
• Skilled in leading and participating to enable highly effective teams
• Strong skills in managing and growing the careers of direct reports
• Full working knowledge of state-of-the art principles and theories, applying such knowledge to the research direction that supports company interests.
• Demonstrates technical proficiency, scientific creativity, collaboration with others and independent thought in suggesting experimental design and research strategy
• Must think critically, creatively and be able to determine appropriate resources for resolution of problems
• Demonstrated ability in developing methods, techniques and evaluation criteria for obtaining results
• Proven track record in producing compounds for preclinical development and clinical trials
• Excellent leadership and organisational abilities

Qualifications: BS in Chemical Engineering with 8 Years of Experience

• Experience leading chemists and managing teams remotely 
• Strong track record of success in chemistry. 
• Experience in Lipid/Fat Chemistry is ideal. 
• Experience with polymer chemistry 
• Separations experience with polymers and lipids.
• Analytics experience with polymers and lipids.
• Experience with fermentation sciences 
• Have an end-to-end understanding of Project Management.
• Ability to deliver multiple complex projects simultaneously with strong attention to detail.
• Executive-level interpersonal, project management, writing, communication and problem-solving skills. 
• Prior experience reporting to Senior Management and/or a Board of Directors
• Prior success handling / executing multiple high impact, fast paced/collaborative projects.
• An outstanding problem solver who is solution-oriented and has a genuine interest in helping.
• Comfortable with operating in a fast-paced environment and dealing with ambiguity. 
• Demonstrated leadership and collaboration skills and ability to form effective partnerships with cross-functional, sometimes remote teams.
• Experience working with recruiters and leveraging networks to identify and hire highly talented individuals and build successful teams locally and abroad.

Qualifications: BA in Chemistry with 5 Years of Experience