Associate Director - Drug Product Formulation (CMC)

Hobson Prior is working with a clinical-stage drug discovery and development discovering organisation who advance pioneering therapies to advance the standard of treatments for serious infectious diseases. Our client is seeking an Associate Director - Drug Product Formulation to join them on a permanent basis, located in Massachusetts.

Please note that to be considered for this role you must have the right to work in this location.

Job Responsibilities:

• Execution of the drug product formulation strategy across drug product life cycle with emphasis in late development stages, registration, validation and post commercialization technical support.
• Perform product development activities aspects related to the dosage form whilst working in partnership with external and internal stakeholders.
• Develop product development and supply capabilities and deliver appropriate control strategy for the associated products.
• Lead science-driven, phase appropriate, and risk-based process/formulation development and process/product specification setting to support clinical programs from proof of concept to commercial registration.
• Oversee tech transfer and future validation of drug product manufacturing processes.
• Manage third-party partnership and collaborations cultivating strong working relationships.
• Manage technology transfers to Contract Manufacturing Organisations.
• Serve as a subject matter expert and author and/or review relevant sections of CMC documentation in support of CTA/INDs, IMPDs and /NDAMAA submissions, amendments, and scientific briefing documents..
• Analyse data and provide scientific explanations and insight for project work
• Work collaboratively with external CDMOs as well as Discovery, Chemistry, Analytical Sciences, Quality, Supply Chain, Regulatory Affairs, Clinical Operations and Clinical Supplies to ensure goal alignment and execution of priorities.
• Provide input in the development of internal SOP's and processes that follow ICH and GXP guidelines.
• Support CMC sub teams and programs.

Requirements:

• MSc or Ph.D in pharmaceutical sciences, chemical engineering or related field and at least 5+ years experience in the pharmaceutical industry.
• In depth knowledge of drug product formulations, process development and late stage development.
• Extensive knowledge of FDA, EMA and ICH guidelines, GXP's.
• Experience with Quality by Design (QbD) and process validation.
• Proven track record of successfully overseeing formulation development and managing outsources activities at CDMO's.
• Experience in authoring relevant sections of regulatory submissions (IND, IMPD, NDA,MAA).
• Thrives in a fast paced environment and able to adjust on changing priorities.

Apply now:

If you are interested in learning more or applying to this exciting opportunity then please click "Apply" and upload a copy of your CV. Alternatively, for further details or to talk directly to a life sciences recruitment specialist directly, please select "Contact me" at the top of this page.

Hobson Prior is a leading life sciences recruiter focused on finding exceptional people and matching them with the finest positions across the globe. Hobson Prior is acting as an Employment Agency in relation to this vacancy.