Technical Operations Specialist - Biotech CDMO - Massachusetts

Burlington Permanent USD70,000 - USD90,000
  • Process development for early phase drugs through small scale commercialization
  • Liaise, guide, + develop wider production team to ensure continuous development

About Our Client

Our client provides global contract research and manufacturing services to the pharmaceutical and biotechnology industries. They are unique in their focus of providing process development for early phase drugs through small scale commercialization. As such their development personnel require an understanding of process development from both a scientific and engineering perspective. Candidates with either background can be successful and will be considered.

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Description

  • Develop batch records for client-specific formulation and filling operations
  • Perform processing operations including equipment preparation, bulk product formulation, sterile filtration, and filling support to facilitate process design and internal technology transfer
  • Identify and specify process specific equipment needed for client tech transfer, developing techniques and process parameters specific to the clients' product while maintaining critical product attributes
  • Assist in authoring instructions for the operation of equipment and for detailing process flows in clean room facility
  • Responsible for maintaining 100% trained on applicable curricula Understands and follows OSHA, HAZOP, and our procedures and guidelines when handling or disposing of hazardous materials and maintaining overall safety culture
  • Performs hazardous waste handling operations in accordance with our procedures
  • Provide guidance to junior team members
  • Creates formulas, recipes, batches, and completes batch consumption in Oracle

The Successful Applicant

  • B.S. in Biology, Chemical Engineering, or related.
  • 3+ years' experience in a cGMP/FDA regulated environment.
  • U.S. employees must be fully vaccinated.
  • Aseptic technique, familiarity with clean room personnel flows.
  • Computer literate with good working knowledge of spreadsheet software (Visio or equivalent drawing programs a plus).
  • Familiarity and understanding of cGMP's in a accordance with 21CFR210, and 21CFR211.
  • Knowledge and understanding of the principles associated with aseptic filling technology (e.g. rotary piston/positive displacement pump, peristaltic pump systems).

What's on Offer

  • Join a talented workforce, where a commitment to excellence and a customer focused attitude is everything.
  • Work to improve patients' lives with the pharmaceuticals you develop and manufacture.
  • Great size: Small enough to remain agile and nimble, empowering you to make your mark in discernable ways as our organization evolves. Yet large enough to provide your work with the potential for global reach and impact.
  • Events that help teams to bond and become even better collaborators: After-hours get-togethers, lunch-and-learns, holiday parties, birthday celebrations and special themed events designed to brighten the workday.
  • Comprehensive total compensation package that aligns directly with business & individual results.
  • Benefits and perks designed to provide support, including health and wellness resources, insurance options, financial resources, and advantages for work, life and family.
Contact
Faith Emery
Quote job ref
JN-012022-4578495

Job summary

Sector
Life Sciences
Sub Sector
Biotechnology
Industry
Healthcare / Pharmaceutical
Location
Burlington
Contract Type
Permanent
Consultant name
Faith Emery
Job Reference
JN-012022-4578495