Associate Director, Process Validation and Tech Transfers
Wave Life Sciences
5 hours ago
On-site
Greater Boston
Operations
Description:
- Lead and oversee development, implementation, and maintenance of validation master plans, process performance qualifications (PPQ), and continued process verification (CPV)
- Guide process validation studies for oligonucleotides and siRNAs, ensuring compliance with cGMP, FDA, ICH, and ISO standards
- Serve as technical subject matter expert for regulatory audits/inspections
- Author, review, and approve technical documentation (validation protocols, reports, risk assessments)
- Lead investigations into process failures and deviations; support CAPAs
- Partner with manufacturing, QA/QC, and development teams for technology transfer and equipment qualification
- Provide technical expertise to manufacturing technicians; support scale-up to manufacturing-ready processes
Experience/Qualifications:
- M.S. or Ph.D. in biochemistry, chemistry, or engineering (preferred) or equivalent work experience
- 8+ years bio-pharma manufacturing experience in a cGMP environment
- Oligonucleotide manufacturing and PPQ experience (required)
Responsibilities:
- Author and optimize “recipes” (method files) on OligoPilot 400 (OP-400) and purification/lyophilization unit operations
- Lead transition from bench-scale (1–4 mmol) to OP-400 (25–100 mmol) and potentially commercial scale
- Provide technical leadership in phosphoramidite chemistry, including specialized siRNA modifications
- Support DoE to establish proven acceptable ranges (PAR) for synthesis/purification for PPQ readiness
- Support transfer of siRNA processes to CDMOs during pre-PPQ and PPQ activities
- Author/review Master Batch Records (MBRs), SOPs, and Campaign Summary Reports
- Provide on-site technical support during GMP and PPQ production runs
- Support manufacturing associates with oligonucleotide production (synthesis, C&D, purification, desalting, lyophilization)
- Initiate/manage process deviations, investigations, and CAPAs during GMP manufacturing
- Drive continuous improvement by identifying opportunities and implementing approved strategies
- Prioritize and schedule work to meet current and future needs
- Ensure accurate recording of methods/materials/results in batch records
- Act as primary manufacturing contact for internal and external (CMO) process transfers; perform technical reviews
- Participate in meetings to troubleshoot manufacturing issues (internal/CMO)
- Draft IND/NDA technical sections (Module 3: Drug Substance)
Key Skills:
- Solid-phase synthesis proficiency; UNICORN software (OP-400) preferred; recipe writing experience required
- Hands-on experience with ASO and siRNA, including RNA stability and duplexing challenges
- Thorough understanding of 21 CFR Part 11 and ICH Q7–Q11
Benefits (as stated):
- Discretionary annual bonus and discretionary stock-based long-term incentives
- Company-sponsored medical, dental, vision, life, and long/short-term disability; generous paid time off (including week-long Summer and Winter shutdown)
- 401K with matching contributions; Employee Stock Purchase Program
- Lead and oversee development, implementation, and maintenance of validation master plans, process performance qualifications (PPQ), and continued process verification (CPV)
- Guide process validation studies for oligonucleotides and siRNAs, ensuring compliance with cGMP, FDA, ICH, and ISO standards
- Serve as technical subject matter expert for regulatory audits/inspections
- Author, review, and approve technical documentation (validation protocols, reports, risk assessments)
- Lead investigations into process failures and deviations; support CAPAs
- Partner with manufacturing, QA/QC, and development teams for technology transfer and equipment qualification
- Provide technical expertise to manufacturing technicians; support scale-up to manufacturing-ready processes
Experience/Qualifications:
- M.S. or Ph.D. in biochemistry, chemistry, or engineering (preferred) or equivalent work experience
- 8+ years bio-pharma manufacturing experience in a cGMP environment
- Oligonucleotide manufacturing and PPQ experience (required)
Responsibilities:
- Author and optimize “recipes” (method files) on OligoPilot 400 (OP-400) and purification/lyophilization unit operations
- Lead transition from bench-scale (1–4 mmol) to OP-400 (25–100 mmol) and potentially commercial scale
- Provide technical leadership in phosphoramidite chemistry, including specialized siRNA modifications
- Support DoE to establish proven acceptable ranges (PAR) for synthesis/purification for PPQ readiness
- Support transfer of siRNA processes to CDMOs during pre-PPQ and PPQ activities
- Author/review Master Batch Records (MBRs), SOPs, and Campaign Summary Reports
- Provide on-site technical support during GMP and PPQ production runs
- Support manufacturing associates with oligonucleotide production (synthesis, C&D, purification, desalting, lyophilization)
- Initiate/manage process deviations, investigations, and CAPAs during GMP manufacturing
- Drive continuous improvement by identifying opportunities and implementing approved strategies
- Prioritize and schedule work to meet current and future needs
- Ensure accurate recording of methods/materials/results in batch records
- Act as primary manufacturing contact for internal and external (CMO) process transfers; perform technical reviews
- Participate in meetings to troubleshoot manufacturing issues (internal/CMO)
- Draft IND/NDA technical sections (Module 3: Drug Substance)
Key Skills:
- Solid-phase synthesis proficiency; UNICORN software (OP-400) preferred; recipe writing experience required
- Hands-on experience with ASO and siRNA, including RNA stability and duplexing challenges
- Thorough understanding of 21 CFR Part 11 and ICH Q7–Q11
Benefits (as stated):
- Discretionary annual bonus and discretionary stock-based long-term incentives
- Company-sponsored medical, dental, vision, life, and long/short-term disability; generous paid time off (including week-long Summer and Winter shutdown)
- 401K with matching contributions; Employee Stock Purchase Program