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Grifols Shared Services North America, Inc Process Development Chemist III 1 in San Diego, California

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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

#SMF

CLK789

Req ID: 172488

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