Senior Engineer, Process Sciences - Drug Product

Responsibilities

• Serve as an engineer responsible for clinical, PPQ, and commercial Drug Product manufacturing for AAV products
• Lead internal and external Tech Transfer for Drug Product manufacturing
• Collaborate with cross-functional stakeholders to support URS development, vendor selection, FAT/SAT for internal Fill/Finish facility
• Collaborate with cross-functional stakeholders to develop CQV protocols and equipment validation strategies
• Provide person-in-plant support of GMP (clinical and commercial) manufacturing as required at internal and external sites of manufacturing
• Develop and maintain manufacturing performance trending tools
• Work with cross-functional teams to develop tools/templates to support tech transfer business processes
• Support regulatory filings and serve as technical SME during regulatory inspections

Requirements

• B.S or M.S. in a relevant area of specialization (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 of experience in MSAT/PD/Process Sciences role preferred
• Hands-on experience with sterile fill-finish operations, aseptic processing preferred
• Extensive working knowledge of modern laboratory procedures and knowledge of cGMP is a must
• Ability to independently design, execute, and analyze fill-finish and drug delivery device studies (extractable volume, formulation development, device compatibility) is a must
• Ability to influence, build, and develop strong working relationships with cross-functional stakeholders
• Strong verbal and written skills are required as well as effective interpersonal, technical, and troubleshooting skills
• Availability to travel based on business need, at times with minimal advanced notice
• Ability to manage multiple technical deliverables in a fast-faced, high-growth environment

Benefits

• Comprehensive benefits package, including competitive employer premium contributions
• Meaningful stock option grants
• PTO, sick time, and holiday pay
• Generous Parental Leave program
• Pre-tax medical and dependent care programs
• STD, LTD, Life and AD&D
• Professional development opportunities
• Team-building events
• Stocked micro-kitchen with drinks and snacks
• Wellness Resources