Job Description
**Job Summary** Seeking highly motivated individual for support position in External Manufacturing Technical Operation team, responsible for technology transfers and commercial production of sterile drug product. We currently have two roles open with our client - remote working with between 25% and 50% travel throughout Europe. Both roles are within Fill Finish, one position requires previous experience with Pre Filled Syringes. **Job Description** The External Manufacturing (Ex M) Technical Operation team is seeking a highly motivated individual for this support position. Ex M Tech Ops is accountable for technology transfers and commercial production of sterile drug product at our External Partners (EPs). Key Responsibilities: * Work with External Partners to achieve business goals and establish a common culture that benefits our company, External Partners, and patients. * Responsible for technical activities for the commercial manufacturing process at the External Partner, including: + Authorship of change control + Management of process improvement projects + Statistical analysis of process performance + Investigation of atypical events * Responsible for technical transfer activities, including: + Authorship and/or review of required GMP documentation (Master Batch Records, change control, protocols, reports, qualifications, etc.) + Regulatory filings * Provide on-site coverage at External Partner in support of Commercial and/or Technology Transfer Person-In-Plant Activities * Translate understanding of GMP requirements and current regulations and develop standardized work to meet these requirements by partnering with Operations, Quality, and External Partners * Ensure that External Partners are inspection ready for all routine inspections and/or inspections related to new product introductions or transfers, in concert with Operations, Quality, and Regulatory **Requirements** * Minimum 3-5 years of experience in Fill Finish Pre-Filled Syringe activities * Bachelor's degree in chemical/Biochemical Engineering, Pharmaceutical Science, or Chemistry/Biology, or other related science or engineering field * Minimum of 4 years post-bachelor's degree experience in a GMP functional area or support of a GMP functional area * Travel will be a requirement of this position at approximately 25-50% * Experience in Fill Finish activities (Vial/Syringe finish, Sterilization, cleaning aseptic manufacturing, etc.) * Demonstrated ability to independently manage projects/work to schedule/deadlines * Statistics experience (including Proactive Process Analysis and Continuous Process Verification) * Experience in deviation management and/or change control and/or equipment support, and/or project management