Position Summary:

The candidate will interact and work closely with research scientists, analytical scientists, and production staff at Contract Manufacturing Organizations (CMOs) in the development of drug substance and drug product processes. While the candidate will be directly supervised by a Senior Process Engineer, he/she is expected to play a significant role in management of CMO activities and is expected to serve as the “man-in-the-plant” at the CMO. In the capacity as “man-in-the-plant” the candidate’s responsibilities will include communication with the CMO, technical oversight/observation of product runs at the CMO, evaluation of CMO performance and, as required, participation in technical training of CMO personnel in processes. The candidate may also be called upon from time-to-time to perform experiments in the Process Development laboratory at MGI to support pre-clinical, clinical, and commercial activities.

Duties & Responsibilities:

Complete assigned activities, with minimal direction, relating to the development and implementation of manufacturing processes, process changes / improvements
Work directly with engineering, chemistry, analytical, validation and quality groups at CMOs during development activities and assures to ensure that CMOs provide timely, documented, technically sound and robust results.
Monitor contractors to assure activities are in compliance with cGMP and applicable regulatory requirements.
Work directly with other MGI functional groups to communicate project specific support needed from them and to coordinate timelines
Writes and/or coordinate the preparation of technical reports and components of CMC submissions for review / approval by Process Development management
Present work to groups for discussion and critique.

Minimum Requirements:

B.S. or M.S. in Biochemical or Chemical Engineering with 5 years of experience or Ph.D. in related field with 1 - 2 yrs experience
Industrial experience in biopharmaceutical drug substance or drug product process development
Mechanical skills and experience in design, start-up, or operation of pharmaceutical production equipment
Experience in or solid knowledge of requirements of working in cGMP production environment
Demonstrated oral and written communication skills.

Desired:

Good interpersonal skills

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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