Position Purpose:

The Senior Engineer/Manager, Process Validation will lead and manage various process validation activities for drug substance (DS) and drug product (DP) manufacturing, label and secondary packaging, and shipping validation processes at Contract Manufacturing Organizations (CMOs). This role involves executing and overseeing process validation and related lifecycle activities to ensure compliance with Good Manufacturing Practices (GMP) and global regulatory requirements. This role requires collaboration across various departments, including Manufacturing, Supply Chain, Quality Assurance (QA), and Contract Manufacturing Organizations (CMOs), to ensure successful development and execution of all validation activities.

This position will report to the Director of Manufacturing Validation.

Key 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.

Required Skills & Experience:

• Bachelor's degree in engineering, Life Sciences, or a related field with 8+ years or Master's and 6+ years of experience.
• 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.
• Demonstrated experience leading validation activities with external CMOs and internal manufacturing partners.
• Prior experience in leading process design and validation of combination drug-device products (e.g. pre-filled syringes, autoinjectors, etc) is a plus.
• 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.
• Level of hire (Senior Engineer or Manager) will be commensurate with the selected candidate's qualifications, scope of prior responsibility, and years of relevant experience.

Location(s):

Stoke is located in Bedford, MA, and will be moving to a new location in Waltham, MA by the end of 2026. This position is eligible for either remote or hybrid work arrangements.

Travel:

This position will require approximately 10-20% travel.

Compensation & Benefits:

At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.

The anticipated salary range for this role is $140,000 - $161,000. The final offer will be determined based on a variety of factors, including role scope, experience and qualifications, education, market benchmarks, internal equity, and geographic location. In addition to base salary, Stoke offers an annual bonus and equity participation.

Our benefits package includes medical, dental and vision insurance; life, long- and short-term disability insurance; paid parental leave; a 401K plan with company match, unlimited vacation time, tuition assistance and participation in our Employee Stock Purchase Program (ESPP).