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Biologics Process Engineer - Person in Plant

Devens, MA 01434

Posted: 05/02/2023 Job Number: 23780912

Job Description

Hybrid Schedule.
Pay Range $51.98-$53.51/hr W2
**Support Commercial Manufacturing Performance at the external manufacturing CMO site
  • Expected to travel to Syracuse, NY once a month would be required

Required Skills:
  • *Bachelor's Degree Required--Master's Degree is Desired
  • Science or Engineering degree in biotechnology, biochemical or related discipline.
  • Experience in drug substance manufacturing essential to the role.
  • +3 years of experience and strong practical knowledge of the technologies related to mammalian cell culture, therapeutic protein purification and process engineering.
  • Demonstrated ability to work independently and prioritize activities.
  • A proven ability to work on complex problems in which analysis of situations/data requires an in-depth evaluation of multiple factors is essential.
  • Experience in technology transfer of processes for commercial manufacture and associated regulatory requirements.
  • Ability to work in a multi-disciplinary team, partner with various functions to provide strong leadership to drive risk-based decisions.
  • Demonstrated ability in technical writing, computer-based knowledge, and communication skills.
Project Description:
This position is responsible for providing technical support to commercial operations in addition to ensuring delivery of technical transfer activities. The position will be responsible for monitoring daily activities at our external manufacturing organization, interfacing with technical, quality and manufacturing representatives at site. This position will support all MS&T related activities at the CMO site and forms part of the MS&T external manufacturing team.
  • Represents MS&T external manufacturing team to provide person in plant technical support to the commercial manufacturing process including deviation resolution, change management, delivery of yield targets and optimization.
  • Maintains strong working relationships with external partner(s).
  • Interface with internal BMS functions such as MS&T, Quality, supplier Change Manager and Supply Chain.
  • Develop and maintain strong technical familiarity with process and process equipment, process optimization evolution and technical problem solving.
  • Tracks progress of routine manufacturing and tech transfer projects against schedule, provides routine updates and proactively identifies operational risks and remediation.
  • Ensures timely escalation of potential technical, compliance or safety issues to the SRM/MS&T team and partners with internal MS&T resources to remediate.
  • Ensures effective communication between technical and quality representatives at the contract manufacturing sire, including other PIP team members.
  • Lead/support technology transfer activities as applicable.
  • Implement and maintain high standard of quality and regulatory compliance to meet and exceed regulatory agency and quality requirements.
This 12+ month position starts ASAP.

Please E-MAIL your resume (attachment to email) with rate and availability to Loren: loren@alphaconsulting.Com


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Loren Graham

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