Engineer/Scientist II, Drug Product
About The Position
The Engineer/Scientist II, Drug Product is an integral part of the Manufacturing Sciences organization and is responsible for supporting the production of clinical and/or commercial Viral Vector in one or more areas of Kriya’s RTP Viral Vector Manufacturing facility with primary support for GMP Drug Product (Formulation, Filling, Visual Inspection, and Bulk Packaging. The Engineer/Scientist will focus on providing vector drug product process support and expertise for ensuring the successful process transfer to support GMP manufacturing operations. This role will ensure tech transfer of viral vector programs from Process Development into Manufacturing, provide technical support to the Manufacturing Organization and will design and execute phase appropriate studies to support product development and regulatory filings. This role will support the aseptic process simulation program. Additionally, this role may be required to provide developmental support for the DP manufacturing process.
Requirements
- Bachelor’s degree, preferably in Science, Engineering or other related field
- 5+ years of relevant related experience or equivalent.
- Experience in GMP manufacturing or manufacturing support, strong preference for aseptic manufacturing experience.
- Experience with drug product filling operations and supporting studies such as Aseptic Process Validation (APS).
- Highly self-motivated and detail-oriented, with proven ability to foster strong relationships with other team members and stakeholders.
- Experience working in a cleanroom environment and good aseptic technique.
- Perform as the Subject Matter Expert (SME) on a variety of projects and range of technologies.
- Must have flexible work hours, and be willing to work outside of normal, scheduled hours; as necessary.
Responsibilities
- Serve as the technical expert for drug product manufacturing.
- Support the aseptic process simulation (APS) strategy and protocols.
- Serve as MS&T representative for onboarding and maintenance of raw materials and components used in the drug product process (container closure system, single use flow paths, and sterile filters).
- Support visual inspection program.
- Define, measure, analyze, and propose improvements to the current process and systems.
- Participates in or leads (as necessary) cross functional teams for tech transfer and manufacturing support.
- Provide technical support for GMP manufacturing runs and hands-on support as needed for rapid troubleshooting including assisting in investigations.
- Author and execute engineering studies, technical reports, material assessments, and process validation protocols.
Benefits
- Flexible Time Off
- Paid Parental & Medical Leave
- Paid Company Holidays
- Fertility & Family Building Benefits
- Medical, Dental, and Vision Insurance
- Employee Assistance Program (EAP)
- Life Insurance
- Short- and Long-Term Disability Coverage
- Equity
- 401(k) with Company Match
- Identity Theft Protection
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Mid Level
