Sr. Scientist, Engineering

Job Description

As part of Our Company’s Manufacturing Division, within the Large Molecule Sciences and Technology (LMS&T) organization, the Large Molecule Tech Transfer (LMTT) department provides the technical process leadership in support of late-stage pipeline and post-market commercial manufacturing processes for vaccines and biologics. LMTT supports various commercialization activities, second generation process development including process characterization, technology transfer to internal and external manufacturing sites, manufacturing investigations, process validation, and authoring of regulatory submissions.  

Job Description:

The Senior Scientist/Engineer will contribute to commercialization activities of late-stage pipeline and/or commercial manufacturing support for biologically derived drug substances (e.g., therapeutic proteins or vaccines). For late-stage pipeline commercialization, activities include process characterization, technology transfer to internal and external manufacturing sites, process validation, and authoring of regulatory submissions.  For commercial programs, activities include site-to-site process transfers, manufacturing investigations and trend evaluations, process enhancements, next generation process development and characterization, process validation, and regulatory submission authoring. 

This person will be responsible for technical leadership on design, planning, and executing laboratory experiments and investigations for the purposes of generating new data and knowledge to enable process development, problem solving, and to reduce risk inherent in scale up or scale down of drug substance processes. Authors experimental protocols and documents work in a lab notebook. Documents lab activities, findings, and conclusions in scientific reports, and presents knowledge at appropriate forums. Ensures proper documentation and compliance with current good manufacturing practices (cGMPs) guidelines and federal, state, and local regulations.

This person may have to manage large multifaceted projects as the leader of a cross-functional team.  As an individual contributor, may be concerned with clearly identifiable elements or functions within a larger project team. May oversee and coordinate work performed by contractors.

This role may require working outside of core business hours to assist with lab studies and/or on-site activities related to tech transfer and manufacturing. GMP tasks include authoring, reviewing, and approving technical and regulatory documents.

Minimum Education & Experience Required:

• Bachelor's Degree in Engineering, Science or related field with a minimum of 5 years of relevant experience; or Master’s degree with a minimum of 3 years of relevant experience; or Doctoral Degree (Ph.D.) with 0 years of experience.

Required Experience and skills:

• Experience in technology transfer 

• Experience with on-the-floor GMP manufacturing support

• Experience with authoring, reviewing, and approving technical and regulatory documents

US and Puerto Rico Residents Only:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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