Formulation Scientist

Job Title

Formulation Scientist

Business:
Pharma Solutions

Department:
Formulation R&D (FRD)

Location:

Lexington

Reporting to the Formulation R&D Manager, the Formulation Scientist is responsible for formulation development of sterile injectable dosage forms, from pre‑clinical development through product commercialization.

• Design studies related to pre‑formulation and formulation of parenteral products, including solubility, pH solution stability, lyophilization, suspension development, polymer development and others that may impact the stability and delivery of the product.
• Experimental design, data evaluation, generation of scientific reports, and coordination studies with other technical groups.
• Play an important role in the scale‑up and technology transfer process in collaboration with the Manufacturing team.
• Investigate, troubleshoot and resolve issues associated with formulation studies and/or R&D pilot manufacturing.
• Develop and track project timelines in collaboration with management, and assume departmental responsibilities for projects when necessary.
• Consult and interact with internal cross‑functional teams and external clients and customers.
• Operate equipment and apply analytical methodology utilized in the formulation development of parenteral dosage forms (e.g. lyophilizers, compounding/filling equipment, mixing techniques, sterilization techniques, HPLC, KF, particulate matter, etc.).
• Apply and provide feasibility assessment for a variety of scientific principles and concepts to potential clients, products and investigations.
• Conduct literature searches to support formulation development and/or pilot manufacturing documentation.
• Effectively communicate and defend own work, orally and in writing, at team meetings, in technical documents, and to external partners.
• Assist, consult, and troubleshoot during process transfer scale‑up and validation activities.
• Interpret results and scientific information, including proficiency in statistical evaluation of data and design of experiments.
• Interact with cross‑functional departments including Business Development, Project Management, ARD, QC, Process Development, Quality, Operations and external clients.

• BS in Chemistry, Biochemistry or Pharmaceutical Science or related discipline.
• 2+ years’ industry experience, focusing on developing parenteral, solid and/or other formulation applications.
• Experience working within a variety of dosage forms (e.g. parenterals, lyophiles, polymers, suspensions, drug delivery systems) and design of experiments, statistics, and unique technologies.
• Experience in lyophilization cycle development and suspension development.
• Experience working within a clinical/commercial manufacturing organization.
• Knowledge of relevant analytical techniques required for formulation and product analysis.
• Ability to serve interdisciplinary and multidisciplinary teams.
• Strong technical aptitude; excellent organizational, technical, and creative problem‑solving skills.
• Interpretation of results and scientific information including proficiency in statistical evaluation of data and design of experiments.
• Flexible and adaptable to changing priorities; comfortable working in a matrix environment while embracing change.