22 days old

Principal Scientist Manufacturing Sciences (Analytical)

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421
  • Job Code
    R0033420

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Job Description

Are you an analytical professional looking for your next leadership opportunity? If this is you, keep reading!

The Principal Scientist is a key member of the Manufacturing Sciences Commercial Manufacturing Support Laboratory group.

You will be responsible for:

  • Manage a team responsible for analytical support of experimental work performed by the Commercial Manufacturing Support Laboratory
  • Provide technical expertise for troubleshooting of process discrepancies and product trends
  • Work closely with Quality to develop implementation strategies for shop floor analytical methods
  • Write and review study proposals, development reports, and regulatory documents
  • Identify and implement improvements in analytical lab operations and equipment

Preferred Skills, Abilities, and Competencies:

  • Ability to develop staff, both technically and professionally; will have 2-7 direct reports
  • Ability to manage and prioritize multiple work streams
  • Experience with HPLC, UPLC, ELISA, IEF
  • Understand common mammalian cell culture and protein purification unit operations; as well as appropriate in-process analytics for each operation
  • Be able to influence, motivate, and drive technical rigor when leading and participating on cross-functional teams.
  • Hands-on experience in multiple analytical techniques related to protein/antibody characterization
  • Experience with method transfer, qualification, and validation
  • Experience with regulatory inspections, filings, and query responses

Internal and External Contacts:

  • Internally, this individual will represent the group to support manufacturing, as a customer with close interactions with the internal business partners including PD, QA, RA and ENG within Takeda.
  • Externally, this individual will interact with vendors who may supply materials or equipment used in small-scale development labs, quality control labs, and in large-scale manufacturing

Education and Experience Requirements:

  • A PhD in Biochemistry or related discipline with 8 years relevant experience; or
  • A MS in Biochemistry or related disciplines with 10 years of relevant experience; or
  • A BS in Biochemistry or related disciplines with 12 years of relevant experience.

Other Job Requirements

Travel may be required for this position, occasionally, both domestic and international.

This job posting excludes CO applicants.

Locations

Lexington, MA

Worker Type

Employee

Worker Sub-Type

Regular

Time Type

Full time





Posted: 2021-03-26 Expires: 2021-04-24
Sponsored by:
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Sponsored by:
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Principal Scientist Manufacturing Sciences (Analytical)

Shire Human Genetic Therapies, Inc.
Lexington, MA 02421

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