Senior Scientist, Principal Engineer

Green Key Resources
Gaithersburg, MD
Sep 16, 2021
Sep 22, 2021
Full Time
We are seeking a Senior Scientist/Engineer responsible for working closely with development scientists to assist in the development of new products. The candidate will be expected to test control strategies and new technology, as appropriate. Other responsibilities will include post launch optimization of existing products, as well as leadership of validation activities for new products. The candidate must demonstrate a strong understanding of parenteral pharmaceutical processing techniques for both small and large molecule products, with knowledge of cGMPs, experimental design and statistical analysis. The Sr. Engineer will be accountable to provide designated characterization support in the development of new Parenteral products, develop new capabilities and innovation. Technical writing and communication skills are critical in this position. Influential behavior and technical leadership are a must with responsibility for mentoring/coaching junior associates.Responsibilitiesinclude but are not limited to:Direct scale-up, transfer, and validation of parenteral products and processesDevelop user requirements, functional design specification for procurement, design and qualification of new parenteral processing equipment and systems.Provide in-depth knowledge and experience to support deviation investigations and product impact assessments.Strong analytical skills with fundamental understanding of the first principles of engineering.Troubleshoot manufacturing issuesCommunicate and present to management and outside agenciesProject managementNew technology evaluationCoach and mentor technical associates.Minimum requirements:PhD or Equivalent Experience: in Chemistry, Engineering, or Pharmaceutical Sciences10 + years' experience in pharmaceutical parenteral manufacturing (aseptic processing)Isolator / Barrier expertiseTechnology transfer process for sterile productsGMP knowledge and understanding of sterile drug product developmentThorough understanding of commercial manufacturing equipment and experience with preparation of regulatory submission documentsSDL2017

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