Engineer III, Drug Product Process Development - Biotech - MA

Canton Permanent USD80,000 - USD95,000
  • Cutting edge biopharmaceutical company in extreme growth mode
  • Develop sterile drug product processes that enable clinical supply

About Our Client

Our latest client is a publicly-held, global biotechnology company based in the MA Norfolk county that focuses on mRNA R&D to generate life-changing therapies. The fast growing business plans on expanding to markets around the world by the end of 2021.

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

  • Oversee processes related to fill/finish packaging, labeling, and logistical support for clinical trial products, as well as large scale manufacturing.
  • Develop protocols to evaluate the compatibility of the drug product with processing materials, container closure components, and sterilization processes.
  • Serve as subject matter expert on particulate control and visual inspection processes across fill/finish operations.
  • Serve as subject matter expert on complex aseptic liquid and lyophilization filling applications. Equipment includes state-of-the-art, highly automated systems, as well as traditional, legacy systems.
  • Ensure that assigned processes are cGMP compliant and are designed to meet the regulations of the U.S FDA and the EMEA.
  • Act as the sending unit for technology transfer of drug product processes, both internally and to external CMOs. Serve as person-in-plant, where applicable.
  • Develop processes suitable to ensure long-term stability of bulk and vialed drug product.
  • Develop robust procedural controls for non-GMP filling operations.
  • Support scale-up/scale-down of drug product manufacturing (e.g. Fill/finish, Freeze/thaw, Lyophilization)
  • Implement screening, sizing, implementation, and phase-appropriate validation activities for sterilizing grade liquid filters in support of fill finish activities.

The Successful Applicant

  • BS/MS in Pharmaceutical/Chemical Engineering, or related Scientific/Engineering Field
  • M.S with 0-2 years experience in Biopharma, Pharma, or Biotech Industry
  • B.S with 2+ years of experience in Biopharma, Pharma, or Biotech Industry
  • Experience with aseptic liquid filling of vials is required
  • Knowledge of best practices and trends in disposable sterile technologies
  • Experience with Process Scale up/Scale Down
  • Experience with Tech Transfer of FDA-Regulated Manufacturing Processes
  • Understanding of FDA, EU, ICH guidelines
  • Experience in GMP environment and understanding of Process Validation/Qualification methods
  • Hands on experience with sterile filtration unit operations
  • Experience working on design of filter validation studies
  • Aseptic lyophilization experience is preferred

What's on Offer

  • Rapidly growing organization w/ extensive growth opportunity
  • Fast paced position supporting multiple functions
  • Highly competitive base salary
  • Stock options
  • Annual bonus incentive
  • Great benefits package
  • Company IPhone
Contact
Faith Emery
Quote job ref
1546575

Job summary

Sector
Sub Sector
Location
Contract Type
Consultant name
Faith Emery
Job Reference
1546575