Job Title

Formulation Scientist



Reporting To

Team Lead


Chantilly, VA


Under general supervision, performs formulation activities as required for, but not limited to, oral, transdermal, topical, oral, nasal, and ophthalmic route projects. Carries out laboratory work to support product formulation and development, stability work, excipient, and packaging sourcing.

  1. Developing complex pharmaceutical products, leading to successful ANDA filings and approval in a timely manner.
  2. Managing and scheduling multiple projects, setting objectives, prioritizing activities to meet the milestones in a fast pace environment.
  3. Designing, formulation and process development for various drug from project initiation to commercialization by following appropriate GMP regulations and safety requirements.
  4. Participate in the set-up and operation of pilot scale equipment and instrumentation for the completion of small production runs in collaboration with the R&D technician.
  5. Design and conduct pre-formulation and formulation studies, process development and optimization of prescription dosage form designs and ANDA oral Dosage forms using DOE
  6. Perform Literature search and Evaluate patents to develop non-infringing strategies
  7. Preparation of product manufacturing, batch records and protocols for different product development stages, including from R&D prototype formulations to process validations following SOPs and procedures, ensuring the detailed record and data keeping.
  8. Utilize formulation techniques, processing equipment and unit operations including Wurster Coating, Tablet Coating, Compression, Blending, Encapsulation, HPLC, Spectrophotometry, Dissolution, Viscometer to develop Bio-Equivalent products
  9. Review Analytical Data, draft SOP’s, Process Evaluation protocols, IQ, OQ, PQ protocols and GMP Manufacturing Batch records, Packaging Batch Records.
  10. Characterization of APIs, excipients and in process products; analysis of in-process samples or in-process products based on protocols and QbD concept, preparing various formulation samples to support cross-functional programs as needs.
  11. Setting-up and cleaning equipment for experiments by following the SOPs, maintaining formulation Lab in a clean and safe working environment.
  12. Establishing documentation management systems for CMC development and meeting FDA GMP, regulatory requirement, and FDA onsite inspections.
  13. Comprehensive knowledge of Quality by Design (QbD) and Design of Experiments (DOE).
  14. Professional knowledge of manufacturing principles, theories, and techniques.
  15. Ensuring all regulatory documents in compliance with SOPs, FDA Regulations, and cGMP policy where applicable.
  16. Completes documentation associated with manufacturing processes (e.g. batch record, protocols, and logbooks) with detail and accuracy.
  17. Meets requirements for entries on all applicable Batch Production pages, completion and attachment of all dispensary and weight verification tickets.
  18. Verifies the manufacturing process on BPR in an accurate and timely manner.
  19. Provides status updates and operational challenges on status boards.
Qualifications and Experience
  1. BS or MS in Chemistry, Pharmacy, Biochemistry, Biology or Bio-technology or related field.
  2. 2-3 years of experience in core formulation development and analytical instrument techniques.