Associate Director, Drug Product Manufacturing and Development

Invivyd • New Haven, CT

5h

About The Position

The Associate Director Drug Product Manufacturing & Development will report to the Head of Manufacturing and Process Development and is responsible for drug product manufacturing and development activities being conducted at Invivyd’s Contract Manufacturing Organizations (CMOs). The individual in this role will make key contributions towards successful technology transfer, process scale-up, process characterization, process validation, and clinical and commercial manufacturing supply efforts.

Requirements

• BS/MS in Pharmaceutical Engineering, Chemical Engineering, or related Scientific/Engineering field with 5-10 years of Biopharmaceutical, Pharmaceutical, or Biotechnology industry experience
• Experience in biologics drug product manufacturing and development including tech transfer, scale-up, late-stage validation, and commercial manufacturing
• Experience with aseptic filling of liquid vials, pre-filled syringes, and drug product devices
• Knowledge of best current industry practices and trends in disposable sterile technologies
• Working knowledge of relevant FDA, EU, and ICH guidelines and regulations
• Knowledge of cGMP regulations, process validation principles, and aseptic processing principles
• Must have strong decision-making, leadership, and interpersonal skills
• Able to effectively communicate with external partners, peers, and senior management
• Able to travel as required ~25% of the time

Responsibilities

• Serve as a subject matter expert and provide direct oversite (as person in plant) for drug product manufacturing activities at CMOs including formulation, aseptic filling, visual inspection, and packaging
• Lead and manage the execution of various drug product related studies including filter validation, extractables and leachables, in-use material compatibility, and shipping
• Facilitate timely execution, disposition, and release of drug product batches through detailed technical review of master batch records, executed batch records, and other cGMP documentation
• Support technology transfer and oversee transfer activities for drug product unit operations
• Provide technical support and participate in formulation development activities
• Ensure that assigned processes are cGMP compliant and are designed to meet Regulatory requirements
• Provide relevant information for drug product sections of regulatory filings (including INDs, IMPDs, briefing packages, and other regulatory dossiers)
• Other responsibilities as assigned

What This Job Offers

• Job Type: Full-time
• Career Level: Director