• Design and formulate roll-to-roll wet coating to meet optical, electrical, and mechanical requirements.
• Design and formulate adhesives for the hot stamping process onto nonpolar substrates.
• Set up hot stamping equipment and develop critical-to-function analytical methods for the materials to correlate to adhesion and reliability.
• Design and formulate lacquer, hard coat, or protective coating at lab scales.
• Source polymers, substrates and other materials with desired properties, formulate and optimize formulation to provide desired properties.
• Scale up all the formulations, establish quality control test methods, and specifications
• Work with process engineers for roll-to-roll coating process optimization, and provide documentation and training.
• Investigate and explore new ideas, demonstrate proof of concept, and create new intellectual property.
• Participate in cross-functional teams in technology and product development.
• Effectively communicate with all levels of the organization, and promote and contribute to a cohesive team working culture.

Skills: Formulation Design, Adhesive Development, Hot Stamping, Analytical Methods, Polymer Sourcing, Scale-Up, Process Optimization, Collaboration

• Develop and review specifications for new products for suitability within existing manufacturing systems
• Recommend applicable testing based on product specification and written procedures
• Optimize formulations to improve product cost and efficacy
• Review and interpret analytical data related to all new and innovative products
• Conducts patent searches to determine freedom to operate with a new formulation
• Creates project timelines following marketing priorities and sets milestones/critical paths for project completion
• Support with stability and production processes
• Evaluate technical issues and provide recommendations for corrective actions
• Support product registration documentation and product chemistry packages to meet regulatory requirements
• Assist and train co-workers, lab assistants, and analysts

Skills: Product Specification, Testing Recommendations, Formulation Optimization, Data Analysis, Patent Search, Project Management, Stability Support, Regulatory Compliance

• Design and production of topical formulations.
• Evaluate new and alternative raw materials for functionality and stability.
• Optimize formulation stability and quality.
• Maintain, characterize, and formulate edible bubbles.
• Perform ingredients stability and compatibility studies.
• Communicate in a timely fashion, all information regarding formulation, project status, raw material research, and results.
• Write her/his notebook accurately.
• Work with the product, QC and marketing team to adapt formulation.
• Prepare and review standard operating procedures as well as internal and external protocols and reports.
• Write technology transfer documentation as well as documentation intended to support the intellectual property.
• Conduct an intellectual search for technical information through a variety of resources.
• Prepare and communicate the results to the management and marketing teams.
• Audit contract manufacturers' facilities and process protocols.

Skills: Formulation Design, Raw Material Evaluation, Stability Optimization, Edible Bubbles, Ingredient Compatibility, Communication, SOP Preparation, Intellectual Property Documentation

• Drug Formulation knowledge to assist the company in the development of new products and enhancements to existing product knowledge and Technicals.
• Responsible for drug formulation consultancy to the clients, including but not limited to, processing, development, testing, and specification setting.
• Spokesperson to the public regarding the company’s drug formulation technologies.
• Ensure that all regulatory and internal policies are followed.
• Generate written knowledge and formulation that meet company and regulatory requirements.
• Oversee outside vendors and consultants
• Support company goals and objectives, policies and procedures, Good Manufacturing Practices, and FDA and international regulations.
• Participates in the preparation of detailed technical documentation, development, and fabrication.
• Technical advisor/consultant to senior management and other functional areas.
• Maintain contact with customers, appropriate technical sources, and business developments to stay up to date with the most current advances and business climate.

Skills: Drug Formulation, Consultancy, Regulatory Compliance, Technical Documentation, Vendor Management, GMP and FDA Compliance, Technical Advisory, Customer and Business Development

• Define and develop new formulations from pre-formulation activities in the laboratory up to final market formulation.
• Ensure the integration between the formulation development and the analytical activities.
• Identify the drug substance and drug product critical quality attributes and the definition of the acceptance criteria
• Evaluate the interaction with contact materials, i.e., primary and secondary packaging, as well as any device used for the administration, and design a suitable process for the target product.
• Participate in the inter-disciplinary technical teams and collaborate with the risk management activities, identifying the project risks and building mitigation actions and contingency plans.
• Manage the interaction with external laboratories and CROs/CMOs involved in the product development.
• Plan the development process in terms of cost and deliverables.
• Ensure timely development of the drug product process to support the pre-clinical and clinical development, and scale-up at pilot and industrial levels.
• Promote continuous improvement of formulation, helping in finding innovative solutions.
• Coordinate technical staff activities to ensure activities completion.

Skills: Formulation Development, Analytical Integration, Quality Attributes, Packaging Interaction, Risk Management, External Collaboration, Development Planning, Continuous Improvement

• Provide technical support within the formulation and cross-functional team
• Develop and review proposed formulas and associated ingredients
• Conceptualize and develop formulas suitable for commercialization
• Develop and maintain support substantiation for structure-function claims, nutritional, and technical information
• Act as a secondary reviewer and sign off on formulas and formula-related documents from others on the R&D team
• Develop, update, and maintain formula substantiation based on regulatory feedback about registration documents and labeling
• Liaise with the Purchasing team on R&D review of initial formula quotes before submission to Client Services
• Prepare and update stability protocols for products and evaluate stability data results
• Collaborate with the R&D Technical Support team on stability monitoring, summaries, and protocol revisions
• Design and conduct appropriate experiments appropriate for the pilot laboratory, collaborate with the Director of Technical Operations and the Product Development Technician on pilot and manufacturing trials
• Develop new techniques, testing, and other areas related to product development
• Proper use of laboratory and manufacturing equipment
• Provide technical and scientific input, support, and assistance to other technical disciplines

Skills: Technical Support, Formula Development, Structure-Function Claims, Regulatory Substantiation, Formula Review, Stability Protocols, Experimentation, Technical Collaboration

• Development of drug formulations based on sound scientific principles
• Procurement of branded products, APIs, and inactive ingredients that meet regulatory standards
• Deformulation of branded and other marketed products (Q1/Q2/Q3 evaluations)
• Selection and procurement of packaging components
• Optimization of lab formulations, including stability studies
• Scale-up formulations from lab to pilot plant to commercial quantities
• Evaluation and procurement of laboratory equipment, pilot plant, and commercial equipment
• Manufacture R&D, Clinical, and Exhibit batches
• Develop product specifications for in-process, release, and stability
• Write all technical reports, including Product Development Reports
• Work closely with Analytical Research to formulate and formulate ANDA/NDA/(505)(b) (2) products
• Work closely with the Regulatory department to file ANDA/NDA/(505)(b)(2), and develop responses for IRs and CRLs, and Clients
• Work closely with other departments such as Regulatory, Intellectual Property, Quality Control, Quality Assurance, Biopharmaceutics, and Operations to get new ANDA/NDA/(505)(b) (2) products approved by the FDA in a timely and efficient manner
• Maintain up-to-date knowledge and expertise with relevant literature and FDA regulatory guidance, including cGMP/cGLP
• Maintain a high level of quality and regulatory compliance

Skills: Drug Formulation, Procurement, Deformulation, Packaging Selection, Lab Optimization, Scale-Up, Technical Reporting, Regulatory Compliance

• Formulate new, innovative healthcare and cosmetic products.
• Conduct stability and compatibility studies.
• Source for new and alternative raw material suppliers.
• Act as a primary contact internally and to external collaborators for all formulation-related matters
• Schedule experiments and prioritize assignments to meet project objectives and deadlines.
• Record accurate and complete experimental methods and results
• Document standard operating procedures (SOP), specifications, etc.
• Maintain laboratory equipment and chemicals in a safe manner
• Check and manage inventories of lab supplies and raw materials
• Maintain records of all work by completing laboratory notebooks.
• Conduct experiments, observing, interpreting and responding to results.
• Ensure that laboratory equipment is operated following safety and risk guidelines.
• Operate following the Company’s Health and Safety policies, especially within a laboratory environment.
• Maintain and increase technical knowledge in relevant fields through self-study, observation, attending relevant conferences, and training courses.

Skills: Formulation Development, Stability Studies, Raw Material Sourcing, Collaboration, Experiment Scheduling, SOP Documentation, Laboratory Safety, Inventory Management

• Interface with 3rd party formulation technology providers to define focused research programs, monitor progress against technical milestones and project timelines, and ensure scale-relevant results.
• Support in-house dry formulation development
• Assist in the identification and evaluation of contract manufacturing organizations capable of executing Ascus’ formulation processes
• Execute capital projects to acquire and install formulation and fill/finish equipment and utility infrastructure.
• Oversee the transfer of formulation processes to contract manufacturing sites.
• Ensure that all work is conducted responsibly and safely following the company's Health and Safety policies, and ensure that all Health and Safety considerations are appropriately documented.
• Conduct and document work to cGMP, ensuring that projects are conducted following company procedures and the agreed timelines
• Document all project work to a high standard, including contemporaneous, complete, and clear documentation of laboratory work in laboratory notebooks and the timely completion of all necessary project administration.
• Communicate to line managers, progress on assigned work and associated milestones on time.
• Prepare, ensure accuracy, and/or maintain accurate records of all technical documents and relevant development projects
• Follow efficient operations in assigned project areas following NAI requirements, SOP's and GMPs
• Take a leading role in projects and support other projects within the formulation team
• Maintain awareness of and update training

Skills: Formulation Development, Research Program Management, Contract Manufacturing Evaluation, Capital Projects, Process Transfer, Health and Safety Compliance, Documentation, Project Communication

• Design and execute studies targeting inert ingredients, physico-chemical properties of formulated products, free-for-registration formulation concepts, Application Technology, and compatibility with commercial fertilizers
• Work cross-functionally with manufacturing and biology researchers to determine the shelf life and stability of field trial materials
• Develop data package and QC standards for new products before transfer to production
• Contribute to product specification
• Formulate prototypes for greenhouse and field testing, to reach commercialization
• Execute analysis of COGs while contributing to labels
• Identify concepts and participate in experimental designs, results discussions, and future marketing plans
• Lab-scale production of formulations designed with SeraNovo's core technology
• Conduct formulation performance tests, with an emphasis on biorelevant dissolution and physical stability testing (UV-vis spectrophotometry, DLS, permeability assays, DSC, and polarized light microscopy
• Proactively identifying and suggesting solutions to critical issues that may delay projects
• Critically reviewing data and results generated alone initially and then together with the project leader
• Work closely with the analytical team to ensure accurate and timely analysis of samples for assay/purity via HPLC-UV or HPLC-MS

Skills: Formulation Design, Cross-Functional Collaboration, Data Packaging, Product Specification, Prototype Development, COG Analysis, Experimental Design, Performance Testing

• Progressive scientific experience, preferably in a related life sciences field.
• Advanced knowledge of varied aspects or a specialized aspect of a discipline
• Working knowledge of principles and concepts of other relevant disciplines.
• Excellent understanding of scientific methodology as related to the pharmaceutical industry.
• Thorough knowledge of Good Manufacturing Practices.
• Strong proficiency in Microsoft Office Suite (Word, Excel, and PowerPoint).
• Excellent critical and logical thinking skills
• Effective written, interpersonal, and presentation skills, including managing technical discussions with internal and external clients.
• Ability to work on multiple projects simultaneously.
• Ability to develop knowledge and skills in pharmaceutical processes, equipment, instrumentation, and procedures.
• The ability to develop technical solutions.
• Ability to keep current with scientific literature and industry trends relating to process technologies.

Qualifications: BS in Pharmaceutical Technology with 5 years of Experience

• Experience working in cosmetics/nutraceuticals
• Experience developing solid dosage products in pharmaceutical/nutraceutical
• Experience in dietary supplement formulation and testing across form factors, including liquids, capsules, powders, quick dissolve, and tablets
• Understanding of regulatory compliance with cGMP, FSMA, HACCP, and US FDA
• Understanding of food and supplement/cosmetic technical specifications, manufacturing records, and other product documentation
• Strong relationships with high-quality suppliers and manufacturing, and the ability to form external vendor relationships
• Understanding of commercial and regulatory trends in the dietary supplements/cosmetic industry
• Has strong planning, time management, and organizational skills to ensure the completion of tasks to meet project timelines
• Passionate about product formulations and obsessed with researching and identifying ingredients to be used to produce safe and high-quality products
• Incredible attention to detail and a strong background in using scientific knowledge and expertise to make strategic decisions
• An understanding of and appreciation for regulatory affairs and experience with evaluating the safety profile of ingredients (GRAS, NDI, etc)

Qualifications: BS in Chemical Biology with 4 years of Experience

• Experience in GMP and ISO environments
• Experience in completing documentation (GDP) and data collection in a GMP laboratory
• Experience in the medical device and/or biotechnology industry
• Familiarity with regulatory guidelines for medical devices or biotechnology products
• Understanding of stability testing and packaging materials
• Proficient in using laboratory information management systems (LIMS)
• Ability to perform physical and chemical property testing of formulations
• Good oral and written communication skills
• Must be innovative and self-motivated, multi-task and work as a team for a common goal.
• Ability to operate lab equipment and to apply common sense to carry out basic written or oral Instructions.
• Proficient at troubleshooting problems.

Qualifications: BS in Chemical Physics with 2 years of Experience

• Excellent working knowledge of drug formulation procedures, including the use of designed experiments and GMP/GLP requirements.
• Strong working knowledge of Long-Acting Injectable (LAI) formulations.
• Expertise in general laboratory analysis techniques.
• Team player with excellent interpersonal and communication skills.
• Experience in technical writing as evidenced by scientific publications, presentations, etc.
• Experience guiding and mentoring junior staff.
• Ability to lead projects and organize and guide the work of interdisciplinary team members.
• Constantly thinking of continuous improvement opportunities
• Have incredible attention to detail 
• Strong planning, time management, and organizational skills
• Must be computer literate

Qualifications: BS in Analytical Chemistry with 1 year of Experience

• Experience working as a formulation in a Pharmaceutical Company.
• Experience in formulation and pre-formulation of both liquids and solids
• Experience with experimental design and execution (including interaction with CDMOs)
• Experience in the development of Biologics (particularly recombinant protein and mAb)
• Good knowledge of pharmaceutical development, especially regarding techniques for the development of sterile and oral formulations, including basic characterization
• Good knowledge of formulation development and processing of Pharmaceutical Products
• Good knowledge of GMP manufacturing processes and documentation
• Good knowledge of solid-state chemistry and physical properties
• Leadership experience in mentoring and training junior scientists within R&D teams.
• Strong problem-solving abilities and analytical thinking to address complex formulation challenges.
• Excellent communication skills, both written and verbal, for conveying technical information clearly to cross-functional teams and stakeholders.
• Strong attention to detail to ensure the accuracy and integrity of experimental data and documentation.
• Innovative mindset to drive new ideas and approaches for improving formulation development processes.
• Flexibility and adaptability to changing project requirements and industry regulations.

Qualifications: BS in Chemistry with 7 years of Experience

• Practical or academic experience in agriculturally relevant fields, including Agronomy, Plant Breeding, Plant Pathology, Plant Science, Horticulture, or Entomology
• Project management work experience
• Chemistry, primary and secondary biological metabolite chemistry, and associated technical skills
• Experience with experimental design and statistical analysis
• Basic molecular biology skills such as sequence analysis, PCR, and related techniques
• Experience working with data entry and basic data summarization, and analyses
• Excellent organizational and recordkeeping skills
• Ability to work well in a collaborative, product development-driven small team
• Ability to engage in multiple projects and tasks, prioritize tasks, and work under pressure
• Proficient with components of Microsoft Office and other standard databases and programs
• Solid written and verbal English communication skills, preferably French

Qualifications: BS in Forensic Science with 2 years of Experience

• Extensive experience with the design and development of agricultural formulation
• Demonstrated competence in the area of formulation technology (including colloids, interfacial phenomena, rheology, solids processing, etc.).
• Prior experience in research or manufacturing/engineering.
• Working knowledge of formulation design and development, and the product registration process.
• Working knowledge of manufacturing processes and operations
• The ability to work independently and drive projects to completion.
• Strong interpersonal and leadership skills
• Ability to successfully partner with team members and stakeholders (sales, marketing, R&D, regulatory, product stewards, etc) from multiple backgrounds.
• Excellent verbal and written communication skills.
• Ability to clearly articulate the value of technology when talking with customers.
• Good project management skills and teamwork spirit
• Solid computer/software skills (Outlook, Excel, and Word)

Qualifications: BS in Biomedical Science with 5 years of Experience

• Experience working with polymers, surfactants, small molecules, or particles
• Experience applying technical skills to drive project success with limited supervision
• Proven experience in efficiently planning, executing, and documenting a set of activities or tasks on time
• Strong communication skills within a project team and to wider audiences (conferences, meetings, etc.)
• Demonstrable participation in safety initiatives and a strong dedication to a safety-first culture
• Understanding of basic structure-activity relationships of chemical additives (molecules, polymers, and surfactants) including how electronic and steric structure can relatively affect binding to films, surfaces, or other additives in solution.
• Understanding of the basic structure-activity relationship of particles, including how shape, particle size distribution, composition, and surface properties can affect material removal rate and defectivity
• Strong ability to design, execute, and interpret efficient experiments that elucidate key slurry function mechanisms or properties
• Strong communication with efficient sharing of project status and results.
• Demonstrable collaboration with team members at different levels
• The capability to self-teach new technical skills or abilities
• Hold Six Sigma Green Belt and PMP certification

Qualifications: BS in Chemical Biology with 4 years of Experience

• Experience in laboratory techniques commonly used in the analysis of pre-formulation, such as HPLC, PXRD, TGA, and DSC
• Experience working in the LC/MS/MS
• Working experience with mammalian cell culture and in vitro permeability assay
• Hands-on knowledge of form and salt selection methods.
• Sound knowledge of pharmaceutical principles in the pre-formulation development with a range of dosage forms, including solution, suspension, and IV formulations to support PK, pharmacology, and toxicology studies
• Hands-on experience in analytical techniques such as HPLC methods, PXRD, TGA, DSC, and particle size analyses to enable evaluation of early-stage discovery compounds
• Hands-on experience in cell culture and in vitro permeability assay using Caco-2 cells
• Experience conducting preliminary forms and salt screens. 
• Proficient at troubleshooting problems.
• Excellent verbal and written communication skills
• Successful and efficient multitasking and working as part of a multidisciplinary team that works within defined timelines
• Experience guiding and mentoring junior staff.

Qualifications: BS in Chemical Engineering with 6 years of Experience

• Extensive hands-on experience using analytical equipment (UV-vis, HPLC, UPLC, CE-SDS, iCE, Plate reader, etc.) for chemical and structural characterization of protein pharmaceuticals, and other biophysical techniques (MFI, DLS, DSC, etc.)
• Solid understanding of the structure and function relationship for mAb, ADC, bispecific antibodies, and fusion proteins, and their modes of degradation
• Knowledge of the systematic scientific approaches to developing commercially viable protein formulation
• Knowledge of unit operations in aseptic manufacturing for liquid and lyophilized dosage forms (bulk freeze-thaw, compounding/mixing, filtration, filling, lyophilization, etc.).
• Extensive hands-on laboratory skills for the preparation of protein formulation (buffer preparation, protein concentration, buffer exchange, etc.)
• Extensive hands-on laboratory skills for stability setup (stability protocol, sampling pulling strategy, etc.)
• Detail-oriented and excellent skills in record keeping/documentation
• Strong scientific leadership, critical thinking, and the ability to aid in study design, organizing, and presenting complex data sets
• A flexible and timeline-driven mentality
• Strong interpersonal communication skills, both verbal and in written formats
• Prior managerial work experience

Qualifications: BS in Biochemistry with 5 years of Experience