Senior Engineer, Process Sciences - Drug Product

About the role

Encoded Therapeutics is a clinical-stage genetic medicines company developing therapies for severe CNS disorders, using its proprietary vector engineering approach with AAV vectors. It is recruiting a Senior Engineer, Process Sciences (Drug Product) to work at the intersection of genomics and therapeutics, across multiple projects in a fast-paced environment. The workplace is on site.

Key responsibilities

• Serve as the engineer responsible for clinical, PPQ and commercial Drug Product manufacturing of AAV products
• Lead internal and external Tech Transfer for Drug Product manufacturing
• Collaborate with cross-functional stakeholders on URS development, vendor selection and FAT/SAT for the internal Fill/Finish facility
• Help develop CQV protocols and equipment validation strategies
• Provide person-in-plant support of GMP manufacturing at internal and external sites as required
• Develop and maintain manufacturing performance trending tools and templates supporting tech transfer
• Support regulatory filings and act as technical subject matter expert during regulatory inspections

Required profile

• B.S. or M.S. in biochemical engineering, chemical engineering, biological sciences, virology, molecular biology or biochemistry
• At least 10 years of industry experience or equivalent educational experience
• At least 7 years in an MSAT/PD/Process Sciences role preferred
• Ability to travel based on business need, sometimes with minimal advance notice

Required skills

• Extensive working knowledge of modern laboratory procedures and cGMP
• Hands-on experience with sterile fill-finish operations and aseptic processing preferred
• Ability to independently design, run and analyse fill-finish and drug delivery device studies (extractable volume, formulation development, device compatibility)
• Strong verbal and written skills, and ability to build relationships with cross-functional stakeholders

What we offer

• Salary of USD 130,000 to 190,000
• Comprehensive benefits with competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, holiday pay and parental leave
• Pre-tax medical and dependent care programs, STD, LTD, life and AD&D insurance
• Professional development, team-building events and a stocked micro-kitchen