The Process and Product Support Specialist works within the Manufacturing Science and Technology (MSAT) department. This position's primary responsibility is to manage new equipment implementation and the technical responsibilities of the client manufacturing processes. This includes the interpretation of client supplied documentation (i.e. batch records, product inserts, product proposal, work orders, etc.) and translating manufacturing and finishing requirements into specific batch records, specifications and procedures. Leads and/or works within cross-functional teams to support product scale-up, development and technical transfer to support Project Management, Manufacturing, Finishing, Quality Assurance, Quality Control, Business Development, and Validation. Job RequirementsNon-Negotiable Requirements:
- Bachelor's degree in Life Sciences or related field
- A minimum of 2-4 years' related work experience in a pharmaceutical, biopharmaceutical, and/or biotechnology manufacturing environment.
- Experience and expertise in manufacturing of regulated products with a thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
- Proficient computer skills in Microsoft Word, Excel, and Outlook.
Preferred Requirements:
- Knowledge of project management techniques and tools.
- Minimum of 2 years in an aseptic pharmaceutical manufacturing and/or finishing environment.
- Minimum of 1 year work experience in the capacity of MSAT or Technical Services preferred.
Responsibilities Include (but are not limited to):
- Conduct the identification and transfer of manufacturing processes from early-stage development through transition to commercial manufacturing.
- Conduct the identification and transfer of finishing processes (Terminal Sterilization, Inspection, Labeling and Packaging) from engineering through commercial finishing.
- Conduct new equipment and materials identification, evaluation, and procurement in support of new products, product scale up, and process improvements.
- Create and/or revise documentation in support of deviations, quality investigation and corrective actions.
- Work with Manufacturing, Finishing, Engineering, and Quality personnel to solve difficult technical problems, with Subject Matter Expertise (SME) in aspects of manufacturing and/or finishing environment.
- Recommend materials and component applications for new products (i.e. product contact material, filters, tubing, vials, stoppers, caps, cartons, labels, shippers, etc.).
- Directly support production with subject matter expertise to increase efficiency, solve problems, and troubleshoot issues.
Prepare and conduct unassisted training of Manufacturing and Quality personnel for new product introduction, protocol execution and unique manufacturing processes