The Role:

Associate Direct, Drug Product Development.  This individual will report to the Executive Director, and will be responsible for supporting ongoing drug product formulation and manufacturing at our CMO partners.  This role will be a key contributor within the CMC organization, with experience advancing and commercializing biologic drug product programs. The incumbent will be responsible for late-stage commercialization activities of a biologic drug-device product including process scale up, technology transfer to external sites, process validation, authoring of regulatory submissions and support of significant manufacturing investigations. 

As a member of the drug product team, the candidate will have a key focus on driving excellence in process characterization, scale up, transfer, process validation activities and regulatory filing (IND, IMPD, BLA and MAA).

Key Responsibilities:

• Lead and provide oversight to drug product (DP) process design, including characterization, technology transfer, and robust commercial validation
• Serve on cross functional DP work streams and manages DP activities and documents (reviewing/authoring reports, and protocols) through Process Performance Qualification (PPQ), including registration stability study execution, process characterization planning and execution, tech transfer strategy, PPQ readiness, regulatory filings, PAI (Pre‐Approval Inspection) readiness, approval, and launch support.
• Provide technical oversight and use experience gained on scientific/technical issues to guide the team to investigate and close out deviations in timely manner to enable release of manufactured DP batches.
• Ensure integration of primary filled container closure and component specifications and testing with the combination product design.
• Work closely with CMC regulatory team and be accountable for DP CMC sections of filing. Review regulatory strategy and filing readiness and support preparations for agency meetings. Author and review regulatory submissions.
• Effectively/efficiently manage CDMOs and deliver success on drug product supply and BLA filing readiness.

Requirements:

B.S. in Chemical Engineering, Biochemical Engineering Bio-engineering,  Biochemistry, Microbiology, or related field with ten (10) or more years of relevant experience; OR

• Advanced degree in Chemical Engineering, Biochemical Engineering Bio-engineering, Pharmaceutics, Biochemistry, Microbiology, or related field with 5 or more years of relevant experience;

Required Experience and Skills:

• Experience with drug product process development, process characterization, technology transfer and scale-up of processes to manufacturing scales of biologics (mAbs or fusion proteins).
• Experience with drug product unit operations of manufacturing including freeze/thaw, mixing, filtration, filling and inspection of prefilled syringes.
• Working knowledge of regulatory requirements for commercialization including application of Quality by Design principles.
• Working understanding of analytical methods to characterize biologics.
• Experience with late-stage commercialization of biologics drug-device programs through PPQ and launch.
• Effective oral and written communication skills. Ability to effectively author or review technical reports, CMC/CTD sections for IND/IMPD, BLA/MAA filings.
• Ability to effectively articulate understanding of protein and process science to drive decision making on investigations of deviations, impact assessments, design of studies, etc, in a multi-disciplinary team-matrix environment

Work Environment:

• Remote-based
• Dynamic, interactive, fast-paced, and entrepreneurial environment
• This position may require travel up to 25%; Must be able to travel for this position (Domestic or international travel).