Director, Formulations & Development

Our biopharmaceutical client here in Waltham, is growing and looking to add a Director, Formulations & Development to their team (Hybrid).  This role will be responsible for leading formulation development, drug product development, and supporting all technical aspects of drug product technology transfer, validation, and manufacturing.

•    Lead internal formulation activities for company’s monoclonal antibody products in support of discovery and IND enabling development, including onsite, hands-on laboratory work.
•    Provide scientific and technical leadership for outsourced formulation development. Provide technical support for drug product manufacture, technology transfer, and validation.
•    Work with the drug product manufacturing team to design and implement drug product and formulation validation activities to support commercialization.
•    Develop and lead development and tech transfer activities for formulation and drug product life cycle management.
•    Design studies, analyze data, organize results, generate/review reports, and communicate findings to project teams and management.
•    Author and review protocols and technical reports documenting formulation development studies, ensuring compliance with company policies, cGMP, and FDA regulations.
•    Author and review IND/CTA/BLA formulation and drug product related regulatory filing sections.
•    Work closely with Drug Product Manufacturing, Analytical, QC and Process Development partners to assess product quality and product stability.

•    Ph.D. in Pharmaceutical Sciences or a related scientific field with 8+ years of industry experience in biologics formulation study design and execution, scale-up, tech transfer, & Quality by Design (QbD) studies.
•    Experience with relevant analytical technologies used in assessment of molecule attributes and stability, including: HPLC/UPLC, MFI, DSC, DLS, DSF, viscosity, SVP characterization, etc.
•    Experience providing technical support for drug product manufacturing and tech transfer.
•    Past experience overseeing outsourced vendors (CROs/CMOs/CTLs/CDMOs)
•    Experience authoring CMC sections for IND and BLA.