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Process Development Chemist III

Employer
Grifols
Location
San Diego, CA, United States
Start date
Nov 25, 2020

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Responsible for the development of new oligo or Reagent/Sub Assembly processes, transfer into Production and continuous improvement of existing processes. Provides oligo or Reagent/Sub Assembly process support to other Operations Groups.

Primary responsibilities for role:
  • Troubleshoots moderately complex manufacturing process problems.
  • Provides technical support to Operations groups
  • Develops manufacturing processes for transfer to the Manufacturing department
  • Oversees Development builds and guides build schedules for Validation lots as appropriate
  • Independently generates notebook studies and tech reports. This includes product shelf life and hold times
  • Aides in the design of new qualification protocols and participates in the development of validation documents
  • Independently originates simple to moderately difficult change controls
  • Represents department as extended core team member
  • Reports periodically to management on project progress and status
  • Particpates in cost savings and process improvement activities
  • Research, evaluate and purchase new instruments and equipment.
  • Independently produces notebook, development and pilot materials per written directions
  • Analyzes in-process and final product material using the appropriate analystical equipment
  • Creates documents/change control packagess in support of the transfer process. Coordinates these with the Technical Writer if applicable.
  • Completes ERP and cycle count transactions


Additional Responsibilities:
  • Stocks and maintains lab supplies
  • Keep accurate records and documents
  • Maintains lab under cGMP conditions


Knowledge, Skills, and Abilities:
  • Knowledge of cGMP/GLP
  • Proficiency with MS Word and Excel
  • Intermediate Change Control skiills
  • Working knowledge of the appropriate analytical techniques (either for oligos or reagents)
  • Demonstrated ability to accomplish goals while working across departments
  • Strong math skills


Education:

Typically requires a BS or MS degree or equivalent in chemistry, biology, biochemistry or equivalent.

Experience:

BS degree: 4-6 years

MS degree: 1-2 years

Equivalency:

Associate degree with ≥8 years of related experience.

Occupational Demands:

May occasionally lift, carry, push, pull or otherwise manipulate objects up to 25 pounds in weight, and/or lift, carry, push, pull or otherwise manipulate objects up to 10 pounds in weight frequently or continuously.

EEO Minorities/Females/Disability/Veterans
CLK789

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