Position Summary:

Responsible for the design, optimization, scale-up, and technical transfer of out-sourced biopharmaceutical production processes at Contract Manufacturing Organizations (CMOs). The candidate will interact and work closely with research scientists, process scientists, analytical scientists, and production staff both at CMOs and within MGI to develop and implement drug substance and drug product processes from the bench to pilot and production scale. The candidate is expected to work independently, given general directions around an assignment and will be called upon to represent MGI at CMO sites and to represent the PD group in cross-functional project meetings. The candidate will also provide support at CMOs as “man-in-the-plant” during on-going MGI activities at the CMO. Supervision of associate level scientist(s) may also be required. The Candidate may also be called upon from time-to-time to design, manage, and interpret experiments in the Process Development laboratory at MGI and provide experimental support for pre-clinical, clinical, and commercial activities.

Duties & Responsibilities:

Perform assignments with minimal direction after being given general guidance regarding objectives
Work directly with business, engineering, chemistry, analytical, validation, regulatory and quality groups at CMOs during development activities to ensure that CMOs provide timely, documented, technically sound and robust results
Work directly with other MGI functional groups to communicate project specific support needed from them and to coordinate timelines
Demonstrate strong collaborative skills – ability to work well with other technical disciplines including analysts and engineers within the same work group, other work groups at MGI, and at other companies
Present work to groups for discussion and critique and write and review technical reports
Build strong relationships with outside contract organizations while overseeing and critiquing CMO technical work.

Minimum Requirements:

Ph.D. in Biochemistry, Chemical or Biochemical Engineering
5+ years industrial experience in biopharmaceutical drug substance or drug product process development
Solid understanding of cGMP requirements as they relate to biopharmaceutical process development, oversight of production, development & review of batch production records
Understanding and experience developing, scaling-up, and implementing processes
Understanding of the regulatory process
Hands-on experience transferring, executing and overseeing cGMP production processes
Excellent oral and written communication skills.

Desired:

Demonstrated supervisory skills
Experience from Process Development perspective with late-stage or commercial products
Understanding and experience using experimental design techniques (DOE) and software

NOTE: This job description is not intended to be all-inclusive. Associate may perform other related duties to meet the ongoing needs of the organization.

An Equal Opportunity Employer

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