DescriptionTSMS - Senior Technical Transfer EngineerThe Technical Services and Manufacturing Sciences (TSMS) Senior Technical Transfer Engineer will be responsible for supporting all facets of Tech transfer, Process Validation, GMP Floor Support, and Continued Process Verification in accordance with current good manufacturing (cGMP) for clinical and commercial programs. This role will provide strong technical oversight to the production to ensure robust and reliable production processes are established.
Essential Job Functions:- Lead multiple complex technical transfer projects simultaneously from development through commercial manufacturing
- Develop and implement advanced process optimization strategies and statistical process control methodologies
- Serve as technical lead on cross-functional project teams coordinating with Quality, Manufacturing, and client teams
- Provide technical guidance and mentorship to Entry Level engineers and review their work
- Author complex technical documents including Process Validation Master Plans, Comparability Protocols, and tech transfer reports
- Serve as primary technical contact for clients and present technical recommendations in client meetings
- Lead root cause investigations for complex manufacturing issues and assist in developing comprehensive CAPAs
- Evaluate and implement new manufacturing technologies, equipment platforms, and process improvements
- Ensure all activities comply with cGMP regulations, company SOPs, and client requirements
- Author GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing Forms
- Provide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process Verification
- Manage timelines and appropriately prioritize critical path tasks to meet deadlines
- Identify continuous improvement opportunities and lead implementation of those improvements
- Other responsibilities as required
Special Job Requirements:- Bachelor's degree in Science or Engineering required
- Master's degree in Science or Engineering preferred
- Minimum 3 years of GMP experience required
- Minimum 2 years of Technical Transfer experience in pharmaceutical/biotech industry
- Demonstrated leadership experience and mentoring capabilities
- Strong project management skills with ability to manage multiple complex projects simultaneously
- Experience with client-facing technical presentations
- Proficiency in statistical analysis software and process validation methodologies
Additional info about INCOG BioPharma Services:At INCOG BioPharma we have built a world-class CDMO for parenteral injectable drugs. Our culture and priorities are different by design: focused on building long-term value for our customers, we are committed to a service-culture mindset, technical excellence, and a collaborative and team-centered approach to doing business.
If you crave the challenge of creating systems from scratch and believe you have insights for a better way of doing business, which benefits customers by ensuring quality outcomes and accelerating their route to market, we want to hear from you. Unless otherwise specified, all positions are based out of our Fishers, IN offices. Please note, we are a smoke-free campus.
INCOG BioPharma is an Equal Opportunity Employer and prohibits discrimination and harassment of any kind. All employment decisions at INCOG BioPharma are based on business needs, job requirements and individual qualifications, without regard to race, color, religion or belief, sex (including pregnancy), age, physical disability, sexual orientation, family or parental status, or any other status protected by the laws or regulations in the locations where we operate. We will not tolerate discrimination or harassment based on any of these characteristics.
Qualified applicants must be authorized to work in the United States on a full-time basis. INCOG will not provide support for or sponsor work authorization or visas for this role, including but not limited to F-1 CPT, F-1 OPT, F-1 STEM OPT, J-1, H-1B, TN, O-1, E-3, H-1B1, or L-1.
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