Stoke Therapeutics

Stoke Therapeutics

Senior Engineer/Manager, Process Validation

Bedford, Massachusetts, United States · Senior

Sponsorship not specified$10k-$20kDetected 8 days ago
Product ManagementSupply ChainGMPFDA RegulatoryCollaborationRegulatory Affairs

About the role

  • About Stoke: Stoke Therapeutics (Nasdaq: STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
  • Stoke's first medicine in development, zorevunersen, has demonstrated the potential for disease modification in patients with Dravet syndrome and is currently being evaluated in a Phase 3 study.
  • Stoke's initial focus are diseases of the central nervous system and the eye that are caused by a loss of ~50% of normal protein levels (haploinsufficiency).

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.
  • 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.
  • Lead gap assessments and recommend improvements to maintain the validated state throughout the product lifecycle.
  • Support FDA Pre-Approval Inspection (PAI) preparations and address validation-related queries regarding shipping and combination product programs.
  • Demonstrated experience leading validation activities with external CMOs and internal manufacturing partners.
  • 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.
  • 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).

Requirements

  • Strong working knowledge of current Good Manufacturing Practices (cGMP), ICH Q8-Q11, and FDA Process Validation Guidance using a lifecycle approach.
  • Required Skills & Experience:

Nice to have

  • Experience in pharmaceutical or biotechnology with significant expertise in process validation of drug substances and drug products is preferred.

Skills

  • Bachelor's degree in engineering, Life Sciences, or a related field with 8+ years or Master's and 6+ years of experience.
  • Prior experience leading labeling/packaging and shipping validation is preferred.
  • Expertise in oligonucleotide manufacturing is highly desirable.
  • Knowledge of applicable standards and regulations, including ISTA 2A/3A, Good Distribution Practice guidelines.

Compensation

  • The anticipated salary range for this role is $140,000 - $161,000.
  • In addition to base salary, Stoke offers an annual bonus and equity participation.

Benefits

  • At Stoke Therapeutics, we are committed to offering a comprehensive, competitive and thoughtfully designed total rewards program.
  • In addition to base salary, Stoke offers an annual bonus and equity participation.
  • 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.

Company info

  • STOK), is a biotechnology company dedicated to restoring protein expression by harnessing the body's potential with RNA medicine.
  • Using Stoke's proprietary TANGO (Targeted Augmentation of Nuclear Gene Output) approach, Stoke is developing antisense oligonucleotides (ASOs) to selectively restore naturally-occurring protein levels.
  • Proof of concept has been demonstrated in other organs, tissues, and systems, supporting broad potential for Stoke's proprietary approach.
  • Stoke is headquartered in Bedford, Massachusetts.
  • For more information, visit https://www.stoketherapeutics.com/
  • At Stoke, we believe that innovation, the ability to successfully advance our ground-breaking science and having fun as a team are enhanced by being together in person, at least periodically.
  • We allow for flexibility in work arrangements that balance individual's needs and preferences with the needs of our business and our desire to foster a culture of collaboration and innovation.
  • We are committed to being true to ourselves, to our colleagues, and to the people with severe diseases who are counting on us.
  • We embrace diversity within a unique culture that is defined by our values.
  • Our employee-led Diversity, Inclusion, and Belonging (DIB) Committee underscores the importance of DIB to who we are and what we do.

Equal opportunity

  • https://www.stoketherapeutics.com/careers/
  • All applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, physical or mental disability or protected veteran status.
  • Stoke participates in E-Verify.
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This listing is sourced directly from Stoke Therapeutics's careers page and normalized into a canonical job model.