Senior Technical Transfer Engineer

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 manufacturingDevelop and implement advanced process optimization strategies and statistical process control methodologiesServe as technical lead on cross-functional project teams coordinating with Quality, Manufacturing, and client teamsProvide technical guidance and mentorship to Entry Level engineers and review their workAuthor complex technical documents including Process Validation Master Plans, Comparability Protocols, and tech transfer reportsServe as primary technical contact for clients and present technical recommendations in client meetingsLead root cause investigations for complex manufacturing issues and assist in developing comprehensive CAPAsEvaluate and implement new manufacturing technologies, equipment platforms, and process improvementsEnsure all activities comply with cGMP regulations, company SOPs, and client requirementsAuthor GMP manufacturing documentation including Master Batch Records, Bill of Materials and Processing FormsProvide technical guidance and oversight to Operations and Validation group to support Process Performance Qualification and Continuous Process VerificationManage timelines and appropriately prioritize critical path tasks to meet deadlinesIdentify continuous improvement opportunities and lead implementation of those improvementsOther responsibilities as requiredSpecial Job Requirements:Bachelor's degree in Science or Engineering requiredMaster's degree in Science or Engineering preferredMinimum 3 years of GMP experience requiredMinimum 2 years of Technical Transfer experience in pharmaceutical/biotech industryDemonstrated leadership experience and mentoring capabilitiesStrong project management skills with ability to manage multiple complex projects simultaneouslyExperience with client-facing technical presentationsProficiency 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.By submitting your resume and details, you are declaring that the information is correct and accurate.