Note: The job is a remote job and is open to candidates in USA. Stoke Therapeutics is a biotechnology company dedicated to restoring protein expression through RNA medicine. The Senior Engineer/Manager, Process Validation will lead various process validation activities for drug manufacturing and ensure compliance with Good Manufacturing Practices and global regulatory requirements.
Responsibilities
- Lead and execute complex validation projects, including process, labeling/packaging, and shipping validation
- Develop and implement process validation master plans (PVMPs), risk assessments, and validation strategies aligned with lifecycle and quality-by-design (QbD) principles
- Coordinate with CMOs and internal teams to plan, execute, and review validation and qualification activities, ensuring consistent documentation and adherence to standards
- Define acceptance criteria, sampling plans, and load configurations, and perform thermal mapping to assess environmental impacts on product stability and CQAs across all shipping conditions
- Collaborate with internal and external partners to review, approve, and execute validation documentation, including qualification and requalification protocols
- Collaborate with internal and external partners to develop and define key product lifecycle documentation, including quality attribute and process risk assessments (FMEAs), process control strategy documents, continued process verification control plans, etc
- Provide expert input during deviation investigations, Corrective and Preventive Actions (CAPAs), and regulatory audits to ensure compliance with ICH, FDA, and global validation guidelines
- Lead gap assessments and recommend improvements to maintain the validated state throughout the product lifecycle
- Author, review, and approve validation protocols and reports in accordance with GMP and internal quality systems
- Support FDA Pre-Approval Inspection (PAI) preparations and address validation-related queries regarding shipping and combination product programs
- Participate in cross-functional meetings with Quality, Manufacturing, and Regulatory Affairs to align on validation priorities and strategies
Skills
- Bachelor's degree in engineering, Life Sciences, or a related field with 8+ years or Master's and 6+ years of experience
- Demonstrated experience leading validation activities with external CMOs and internal manufacturing partners
- Strong working knowledge of current Good Manufacturing Practices (cGMP), ICH Q8-Q11, and FDA Process Validation Guidance using a lifecycle approach
- Understanding of combination products (drug-device) and regulatory expectations under 21 CFR Part 4, FDA Guidance for Combination Products, and ISO 13485
- Knowledge of applicable standards and regulations, including ISTA 2A/3A, Good Distribution Practice guidelines
- Familiar with statistical methods applied to manufacturing controls such as Design of Experiments (DOE) and Statistical Process Control (SPC) and associated software packages such as JMP
- Experience in pharmaceutical or biotechnology with significant expertise in process validation of drug substances and drug products is preferred
- Prior experience leading labeling/packaging and shipping validation is preferred
- Expertise in oligonucleotide manufacturing is highly desirable
- Prior experience in leading process design and validation of combination drug-device products (e.g. pre-filled syringes, autoinjectors, etc) is a plus
Benefits
- Annual bonus
- Equity participation
- Medical, dental and vision insurance
- Life, long- and short-term disability insurance
- Paid parental leave
- 401K plan with company match
- Unlimited vacation time
- Tuition assistance and participation in our Employee Stock Purchase Program (ESPP)
- Remote or hybrid work arrangements
- Approximately 10-20% travel
Company Overview