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
- Develops, implements, and maintains the Validation Master Plan (VMP) and associated documents and strategies for process transfers and scale-up, cleaning, and equipment validation(external).
- Supports the planning, execution, and documentation of PPQ batches, managing risks and technical transfer activities from Process Development to commercial Manufacturing or Contract Development & Manufacturing Organizations (CDMOs).
- Collaborates with Process Development to author and review CMC technical documentation, including validation protocols, reports, and data submissions, ensuring alignment with regulatory expectations and cGMP.
- Supports and reviews Continued Process Verification plans, monitor critical process parameters (CPPs) and Critical quality attributes (CQAs), and utilize statistical tools for data trending to maintain a state of control.
- Reviews validation investigations, root cause analysis for process failures, and manages corrective and preventive actions (CAPA) to improve reliability.
- Represents the validation function during internal, customer-facing, and regulatory inspections, defending validation strategies.
- Partners with Quality, Regulatory Affairs, and CDMO partners to facilitate audit readiness and technical transfer.
- Collaborates with cross functional teams during all stages of validation-related activities, such as Validation Master Plan (VMP), including but not limited to FMEA, PPQ, QbD, and CPV.
- Reviews "recipes" (method files) on the OligoPilot 400 (OP-400), Purification and Lyophilization unit operations for accuracy and GMP compliance.
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
- Manages the transition from bench-scale (1-4 mmol) to the OP-400 (25-100 mmol) and potentially commercial scale manufacturing. Supports DoE (Design of Experiments) to determine the "proven acceptable ranges" (PAR) for synthesis and purification for PPQ readiness.
- Supports the transfer of siRNA processes to CDMOs during pre-PPQ and PPQ activities.
- Reviews Master Batch Records (MBRs), SOPs, and Campaign Summary Reports as needed.
- Provides support to manufacturing associates in the production of oligonucleotides, including synthesis, C&D, purification, desalting, and lyophilization.
- Identifies and initiates process deviations during the GMP tech transfers, investigations, and CAPAs during external GMP manufacturing
- Supports continuous improvement initiatives by identifying improvement areas, recommending strategies, and helping to implement those strategies once approved.
- Reviews and records methods, materials, and results in batch records according to established formats during tech transfers
- Serves as primary contact for reviewing GMP manufacturing records to ensure proper process transfers internally and externally (CMOs)
- Performs technical review of batch records and process instructions internally and externally (CMOs)
- Participates in meetings to identify and troubleshoot manufacturing issues internally and externally (CMOs)
- Drafts 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
Manager
