Associate Director, Drug Product Manufacturing and Development
Invivyd
9 hours ago
On-site
New Haven County, CT
$152,000 - $202,000 USD yearly
Operations
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 execution of 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 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 regulatory dossiers)
- Other responsibilities as assigned
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
- 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
- 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 execution of 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 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 regulatory dossiers)
- Other responsibilities as assigned
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
- 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