Associate Director, Process Validation and Tech Transfers
About The Position
The Associate Director, Process Validation and Tech Transfers plays a critical role in leading and overseeing the development, implementation, and maintenance of validation master plans, process performance qualifications (PPQ), and continued process verification (CPV). This individual is responsible for guiding process validation studies, particularly those specialized in oligonucleotides and siRNAs, ensuring all activities comply with cGMP, FDA, ICH, and ISO standards. Serving as the technical subject matter expert during regulatory audits and inspections, the Associate Director bridges process development with at-scale GMP manufacturing at contract development and manufacturing organizations (CDMOs). The role involves authoring, reviewing, and approving technical documentation, including validation protocols, reports, and risk assessments, while also leading investigations into process failures and deviations. The Associate Director collaborates closely with manufacturing, QA/QC, and development teams for technology transfer, equipment qualification, and provides technical expertise to manufacturing technicians. Maintaining strict quality standards and cGMP practices throughout the process, this position acts as a liaison between Process Development and Manufacturing, supporting the scale-up of existing processes to manufacturing-ready levels.
Requirements
- M.S. or Ph.D. degree in biochemistry, chemistry, or engineering is preferred, or equivalent work experience
- 8+ years bio-pharma manufacturing industry experience in a cGMP environment
- Oligonucleotide manufacturing and PPQ experience is required
Nice To Haves
- Expert-level proficiency in solid-phase synthesis and UNICORN™ software (used by OP-400) preferred, and recipe writing experience is must
- Hands-on experience with ASO, siRNA (double-stranded RNA), and the specific challenges of RNA stability and duplexing.
- Thorough understanding of 21 CFR Part 11 and ICH guidelines (Q7- Q11).
Responsibilities
- Authoring and optimizing "recipes" (method files) on the OligoPilot 400 (OP-400), Purification and Lyophilization unit operations
- Leading the transition from bench-scale (1-4 mmol) to the OP-400 (25-100 mmol) and potentially commercial scale manufacturing
- Provide technical leadership with a deep understanding of phosphoramidite chemistry, including the handling of specialized siRNA modifications
- Support DoE (Design of Experiments) to determine the "proven acceptable ranges" (PAR) for synthesis and purification for PPQ readiness
- Supporting the transfer of siRNA processes to CDMOs during pre-PPQ and PPQ activities
- Authoring and reviewing Master Batch Records (MBRs), SOPs, and Campaign Summary Reports
- Providing on-site technical support during GMP and PPQ production runs
- Provide support to manufacturing associates in the production of oligonucleotides, including synthesis, C&D, purification, desalting, and lyophilization
- Recognizes and initiates process deviations, investigations, and CAPAs during GMP manufacturing
- Supports continuous improvement initiatives by identifying areas needing improvement, recommending strategies for improvement, and helping to implement those strategies once approved
- Respond quickly and effectively to multiple and changing priorities, and to schedule work effectively to ensure that current and future needs are met
- Accurately and consistently record methods, materials, and results in batch records according to established formats
- Primary contact from manufacturing to ensure proper process transfers internally and externally (CMOs)
- Technical review of batch records and process instructions internally and externally (CMOs)
- Participate in meetings to identify and troubleshoot manufacturing issues internally and externally (CMOs)
- Drafting technical sections for regulatory filings (IND/NDA), specifically focusing on Module 3 (Drug Substance).
Benefits
- company-sponsored medical, dental, vision, life, long and short-term disability insurances
- generous paid time off (including a week-long company shutdown in the Summer and the Winter)
- 401K participation with matching contributions
- Employee Stock Purchase Program
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What This Job Offers
Job Type
Full-time
Career Level
Director
Education Level
Ph.D. or professional degree
Number of Employees
101-250 employees
