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Research Scientist ParenteralsMajor Metro
Job Description:

Research Scientist - Tech Services

This position is in Monoclonal Antibody and Small Molecule (Mab/Small Molecule) group within the Parenteral product group. 

 

Provide technical stewardship of monoclonal antibody and small molecule products.

Collaborate with cross-functional team to support global parenteral manufacturing sites for new product commercialization, process improvements and technology transfers.

Collaborate with process engineers and development scientists to design and transfer robust manufacturing processes to commercial and third party manufacturing operations.  Includes serving as a liaison to CM&C teams to shepherd new pipeline products from development into manufacturing.

Design and execute necessary laboratory and pilot studies, as well as prepare technical reports and/or regulatory submissions to support business objectives.

Suggest and evaluate opportunities for molecule, product and business process improvement.  Includes driving the molecule/product technical agenda with a specific focus on process/productivity improvements in partnership with the Parenteral Productglobal manufacturing sites.

Coach and mentor junior associates.

 

 

Requirements:

Bachelor, Masters or Ph.D. degree in relevant area such as Pharmaceutical Science, Chemical Engineering, Biochemistry, Chemistry, or Biology.

A minimum of 10 years of industrial experience in commercial manufacturing or technical service of parenteral products and/or senior level research and technical transfer experience.

 

Additional Skills/Preferences

Demonstrated examples of leadership, influence, and problem solving skills.

Demonstrated ability to analyze and interpret complex technical data and troubleshoot data issues.

Strong written and oral communication skills.

Preparation, review and response preparation of global regulatory submissions i.e. BLAs and NDAs  and other technical communications.

Ability to Leadership teams to successfully deliver projects on time and in scope.

Working knowledge of statistical design of experiments and analysis.

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