WHAT DOES A FORMULATION SCIENTIST DO?
Published: Mar 27, 2025 – The Formulation Scientist develops and optimizes innovative supplement and food-based formulations across various delivery forms, including capsules, tablets, liquids, and powders. This position researches and integrates novel raw materials and advanced processing techniques to create competitive products that align with consumer insights and market trends. The scientist also ensures compliance with GLP standards while collaborating with regulatory, product management, and project teams to refine formulations and enhance manufacturing feasibility.
A Review of Professional Skills and Functions for Formulation Scientist
1. Formulation Scientist Responsibilities
- Research: Perform research and/or development in collaboration with others for projects.
- Analysis: Make detailed observations, analyze data, and interpret results.
- Experimentation: Design and execute experiments that contribute to project strategies.
- Reporting: Prepares technical reports, summaries, protocols, and quantitative analyses.
- Innovation: Investigate, create, and develop new methods and technologies for project advancement.
- Intellectual Property: Responsible for identifying patentable inventions.
- Formulation Development: Manage formulation development activities for potential products.
- Collaboration: Work with consultants and companies to become knowledgeable about all aspects of the technology.
- Product Development: Utilize knowledge and expertise to develop formulations that can be registered, commercialized, and meet customer needs and expectations.
2. Formulation Scientist Job Summary
- Product Development: Primary product development person for Piramal projects.
- Project Coordination: Coordinate with Project Management in the execution of development projects.
- Production Coordination: Coordinate with Production groups for the introduction of new products.
- Facility Management: Maintain the department facilities, records, equipment, and procedures in line with GMP.
- Skill Development: Develop skills and knowledge relevant to the operations.
- Compliance: Maintain departmental compliance with GMP and procedures for the operation of rooms and equipment, record keeping, and reports.
- Experimentation: Conduct experiments that increase the company's understanding of products it manufactures or intends to manufacture.
- Regulatory Compliance: Responsible for ensuring that Research and Development activities comply with QMS and EHS requirements.
- Intellectual Property: Manage and protect Research and Development assets as intellectual property.
- Budget Management: Budgeting and managing expenses.
- Collaboration: Develop strong, collaborative relationships with other departments/groups and foster an environment of knowledge sharing.
- Industry Awareness: Keep up to date with current trends and advances in Pharmaceutical sciences for oral dosage forms.
3. Formulation Scientist Accountabilities
- Product Development: Lead product development from initial Research and Development up to final product approval with minimal guidance.
- Formulation Development: Take responsibility for pre-formulation, formulation, process, stability, and container closure development studies by QbD (quality by design) for solid-dose pharmaceutical products.
- Problem-Solving: Apply scientific fundamentals and creative problem-solving skills to solve complex technical issues, including complex formulation, stability, and manufacturing issues.
- Technical Documentation: Prepare technical reports, presentations, and CMC documents to support regulatory submissions.
- Cross-Functional Collaboration: Represent formulation or CMC in cross-functional teams.
- Stakeholder Management: Collaborate with internal and external stakeholders and partners, such as manufacturing and clinical BE.
- Project Management: Define the scope, timeline, and resource needs of functional activities and keep the team on schedule.
- Vendor Management: Identify and manage external vendors and partners when needed.
- Opportunity Evaluation: Participate in the evaluation of new product opportunities.
- Regulatory Compliance: Follow pharmaceutical cGMP practices and other relevant regulatory guidelines.
- Mentorship: Develop and mentor junior scientists.
4. Formulation Scientist Functions
- Project Leadership: Lead development projects to meet customer specifications to win business.
- Subject Matter Expertise: Be the subject matter expert in chemistry, resins, additives, modifiers, fillers, etc.
- Market Collaboration: Work closely with marketing to understand product specifications and the voice of the customer, and translate them into the product design.
- Technical Documentation: Create product and technical data packages for customer qualification and product promotion.
- Testing and Analysis: Learn, enhance, and develop chemical and material testing methods for raw material and formulation selection.
- Competitive Analysis: Thoroughly understand technology, products, strengths, and weaknesses versus competitor offerings.
- Research Documentation: Document all findings and learnings in appropriate laboratory notebooks.
- Data Management: Databases and technical reports document findings into appropriate lab books and databases for future reference.
- Intellectual Property: Write invention disclosures and patent applications to protect intellectual property.
- Quality Assurance: Work with a Quality group to develop testing, metrology, and conduct MSA/GRR related to newly developed products.
- Capital Investment: Make recommendations to Management on CAPEX projects to improve safety and product development capabilities.
5. Junior Formulation Scientist Job Description
- Manufacturing Support: Involvement with the manufacture and packaging of investigational products for clinical trials.
- Formulation Analysis: Characterize formulations during the development phase and in developmental stability studies.
- Project Reporting: Assist Scientist/Senior Scientist with written project updates for formulation development, including formulation stability updates.
- Work Planning: Plan and organize the work with a certain degree of autonomy, with due consideration to the resources.
- Health and Safety Compliance: Ensure that all activities are carried out in line with Health and Safety policy and COSHH regulations to ensure the safety of others in any procedures or tasks performed.
- Team Collaboration: Assist other team members as and when required to complete the weekly task.
- Laboratory Operations: Assist in the smooth running of laboratory activities and the maintenance of laboratory standards.
- Waste Management: Undertake general waste disposal and contribute to the general tidiness and cleanliness of the laboratory environment.
- Procurement Support: Raise and complete relevant documentation about the ordering and purchasing of equipment for the department.
6. Formulation Scientist Details and Accountabilities
- Formulation Development: Formulate innovative supplements and food-based products in all delivery forms, including capsules, tablets, liquids, and powders.
- Product Improvement: Revise and improve the existing line of products if necessary, to stay competitive in the market.
- Regulatory Compliance: Maintain laboratory compliance (GLP).
- Innovation: Explore and innovate with novel and natural raw materials, process techniques, and formulations in creative, non-conventional ways to create new products that leverage current consumer insights and needs.
- Research: Proactively scan and research new concepts in natural formulation, materials, and technical opportunities.
- Cross-Functional Collaboration: Work closely with regulatory, product management, and project management teams.
- Formulation Drafting: Draft initial formulation for each new product, keeping the product cost and manufacturing feasibility in mind throughout the development process.
- Testing Specifications: Understand and develop testing specifications for developed formulas.
- Independent Work: Work with general direction, broad policies, and goals with minimum supervision.
- Team Collaboration: Develop a professional and functional relationship with other members of the team and participate in a collaborative effort to move projects forward.
7. Formulation Scientist Additional Details
- Formulation Research: Research and generate new product formulations for capsules, powders, and tablets.
- Troubleshooting: Work with the Research and Development and Operations teams to troubleshoot technical, formulation, and processing issues during product development.
- Customer Formulation: Work with the Sales and Research and Development Director to generate new formulations for customers.
- Project Documentation: Maintain accurate project information, formulations, and specifications.
- Quality Assurance Collaboration: Collaborate with the Quality Assurance department in the development of proper documentation for new formula and product development projects.
- Cross-Functional Collaboration: Work collaboratively with cross-functional teams, including personnel in Sales, Quality Control, Purchasing, and Production on new product development and to resolve ingredient and product technical issues.
- Project Management: Prioritize and manage multiple customer products.
- Pharmaceutical Development: Lead in the development of new OSD pharmaceuticals.
- Product Improvement: Propose and implement remedial actions on current custom-owned and third-party products.
- Technology Transfer: Manage technology transfers, technical projects, and supervise IMP development and manufacture.
- Technical Writing: Develop protocols and project plans as well as author technical reports.
8. Formulation Scientist Role Purpose
- Formulation Development: Development and laboratory work on skincare and personal care formulations.
- Trend Analysis: Keep up to date with the latest trends in Derma and translate them into innovative propositions for new formulations.
- Technology Transfer: Upscale and technology transfer of new formulations to internal and external manufacturing sites.
- Claim Substantiation: Plan and initiate claim substantiation studies with external test institutes.
- Technical Documentation: Prepare scientific and technical documentation for new and updated products.
- Technical Support: Provide technical support to the other functions and affiliates for the product portfolio.
- Product Optimization: Lead effort to optimize and enhance existing formulations for all AIS clinical products.
- High-Concentration Formulation: Oversee high-concentration formulation development at CDMO in both vials and pre-filled syringes.
- In-House Expertise: Implement in-house formulation development expertise.
- Vendor Management: Manage and/or coordinate project vendors (central laboratories, BDS, and DP CDMOs).
- Cross-Department Collaboration: Interact with finance, research and development, regulatory, and other relevant departments as appropriate.
- Project Accountability: Accountable to the company executive management regarding project deliverables.
9. Formulation Scientist General Responsibilities
- Pre-Formulation Studies: Carry out pre-formulation studies on clients' drug substances.
- Product Development: Develop new products for preclinical and clinical, and for the marketplace.
- Batch Manufacturing: Manufacture stability and clinical trial batches within the laboratory area or pilot plant.
- Process Validation: Conduct Process Development and Validation studies where required.
- Technical Documentation: Prepare technical documentation to support development work and manufacturing (including laboratory notebooks, batch records, and process validation documentation) to meet internal, customer, and regulatory requirements.
- Report Preparation: Contribute to the preparation of reports for internal use, clients, and regulatory authorities.
- Equipment Validation: Assist in the validation of new equipment.
- SOP Development: Prepare SOPs for new equipment and procedures.
- GMP Compliance: Maintain and improve standards of Good Laboratory/Manufacturing Practice.
- Technical Awareness: Maintain technical awareness by regular review of literature and training courses.
- Safety Compliance: Work safely following PDS and site procedures.
10. Formulation Scientist Key Accountabilities
- Research Support: Assist the Analytical and Formulation Development Manager (and Head of Research and Innovation) in achieving company goals with a specific focus on responsibilities related to the Research and Development Formulation Science function.
- Collaboration: Work closely and collaboratively with other members of the Formulation Science function along with the Analytical and Process Development functions, and other members of the Research and Development and Commercial value streams to achieve goals.
- Cross-Functional Coordination: Work with the Analytical and Formulation Development Manager, the Innovation team, and the Scientific Affairs (both PMO and Regulatory/Clinical).
- Innovation Leadership: Foster innovative thinking within the Research and Development function and champion the development of innovative medicines in a timely fashion according to stakeholder expectations.
- Formulation Development: Execute and/or oversee the design and development of formulations that are built on sound scientific, regulatory, QbD, process validation, and lean product development principles.
- Product Improvement: Assist in the improvement of existing drug product formulations within the organization by retrospective application of sound scientific, regulatory, QbD, process validation, and lean product development principles.
- QbD Implementation: Champion the use of QbD and scientific thinking in the development of innovative drug product formulations while maintaining a comprehensive knowledge of formulation development disciplines through research and scientific literature.
- SME Interpretation: Act as SME for the interpretation of in vitro data to predict in vivo performance and how this relates to further formulation development.
- Team Culture: Work to create an excellent/SME culture within the formulation science function that is focused on innovation, lean and robust formulation development, and continuous improvement.
- Training Development: Identification, organization, and implementation of effective training programs within the Formulation Science group.
- Representation: Represent the development group in all relevant meetings, for example, pipeline steering committee meetings and Research and Development value stream.
- Regulatory Compliance: Ensure that all work carried out complies with the required standards conforming to company, cGMP, SOPs, regulatory regulations and guidelines, safety and environmental guidelines.
- Data Collection: Ensure contemporaneous collection of relevant data for Research and Development Tax Credit claim purposes.