Grifols Shared Services North America, Inc Process Development Chemist III 1 in San Diego, California
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
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
Typically requires a BS or MS degree or equivalent in chemistry, biology, biochemistry or equivalent.
BS degree: 4-6 years
MS degree: 1-2 years
Associate degree with ≥8 years of related experience.
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.
Req ID: 172488