Invivyd is hiring an Associate Director, Drug Product Manufacturing and Development to lead critical development and manufacturing activities at our Contract Manufacturing Organizations (CMOs). Reporting to the Head of Manufacturing and Process Development, you will be instrumental in ensuring the successful technology transfer, scale-up, validation, and supply of clinical and commercial drug product.
What You'll Do
- Serve as a subject matter expert and provide direct oversight as person in plant for drug product manufacturing at CMOs, including formulation, aseptic filling, visual inspection, and packaging.
- Lead and manage the execution of drug product 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 assigned processes are cGMP compliant and designed to meet Regulatory requirements.
- Provide relevant information for drug product sections of regulatory filings including INDs, IMPDs, briefing packages, and other dossiers.
What We're Looking For
- BS/MS in Pharmaceutical Engineering, Chemical Engineering, or a related Scientific/Engineering field.
- 5-10 years of industry experience in Biopharmaceuticals, Pharmaceuticals, or Biotechnology.
- 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.
- Strong decision-making, leadership, and interpersonal skills.
- Ability to effectively communicate with external partners, peers, and senior management.
- Ability to travel as required ~25% of the time.
Team & Environment
You will report directly to the Head of Manufacturing and Process Development, collaborating closely with internal teams and external CMO partners.
Benefits & Compensation
- Salary range: $152,000 - $202,000
- Eligible for annual long-term incentive (e.g., equity)
Work Mode
This is an onsite role based in New Haven, CT.
At Invivyd we strive to create a welcoming and inclusive environment. Here all applicants will receive equal consideration for employment without discrimination on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability, or any other applicable legally protected characteristics.
