Summit Therapeutics, Inc.

MSAT Director – Drug Product

Summit Therapeutics, Inc.

full-time

Posted on:

Location Type: Office

Location: Abingdon • Florida • United States

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Salary

💰 $100,000 - $120,000 per year

Job Level

Lead

About the role

  • Lead process development/characterization, tech transfer and process validation for sterile drug product, including oversight of external CDMOs and internal teams.
  • Partner with the broader CMC team to implement process, product, and site changes
  • Support, with the team, successful execution of clinical and commercial batch manufacturing in alignment with the development and supply timelines.
  • Be accountable, with the team, to successfully deliver CMC chapters to regulatory documents
  • Actively support dialogue/interaction with regulatory agencies
  • Support PLI/PAI preparation and delivery
  • Responsible for all stages of Process Validation, including CPV (Continuous Process Verification), in accordance with governing quality system requirements.
  • Prioritize post-approval opportunities and develop business cases for further investment/development
  • Foster effective communication and collaboration with internal and external stakeholders, including other CMC functions, Regulatory Affairs, Quality Assurance, and CROs/CDMOs
  • Collaboratively work across the broader CMC, regulatory and quality departments to deliver desired outcomes
  • Collaborate cross-functionally with Regulatory, Quality, Supply Chain, and CMC teams to ensure integrated planning and execution.
  • Ensure GMP compliance across all activities.
  • Support audits and inspections.
  • All other duties as assigned

Requirements

  • MSc degree in Engineering, Biochemistry, Pharmaceutical Sciences, or related field; PhD preferred.
  • Minimum of 10+ years of experience in biologics manufacturing, with a focus on sterile drug product and late-phase development.
  • Proven track record in BLA preparation, PPQ, and commercial launch.
  • Strong knowledge of regulatory expectations (FDA, EMA) for biologics and sterile drug product(s).
  • A strong team player and promotor of inclusion and collaboration
  • Able to handle multiple projects simultaneously while maintaining high-quality results
  • Capable of providing and implementing innovative solutions to unique and pressing situations
  • Experience managing CDMO partners and internal cross-functional teams.
  • Excellent leadership, communication, and project management skills.
Benefits
  • bonuses
  • stock
  • benefits
  • other applicable variable compensation

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard skills
process developmentprocess validationtech transferBLA preparationPPQGMP complianceContinuous Process Verificationbiologics manufacturingsterile drug productclinical batch manufacturing
Soft skills
leadershipcommunicationproject managementcollaborationteam playerinclusionproblem-solvingmulti-project managementstakeholder engagementinnovation
Certifications
MSc degreePhD preferred