Process Development Chemist II
San Diego Metro Area, CA
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.
Provides support to Operations groups
Assists in the development of manufacturing processes to transfer oligos or reagents/sub-assemblies to Manufacturing
Assists with the creation of documents/change control packages in support of the transfer process.
Coordinates these with the Technical Writer if applicable.
Executes process validation protocols
Originates simple change controls
Participates in cost savings and process improvement activities
Installs and validates new instruments or equipment.
Participates in the notebook, development and pilot builds per written directions
Completes ERP and cycle count transactions
Stocks and maintains lab supplies
Keep accurate records and documents
Maintains lab under cGMP conditions
Knowledge of cGMP/GLP
Proficiency with MS Word and Excel
Intermediate Change Control skills
Working knowledge of the appropriate analytical techniques (either for oligos or reagents)
Strong math skills
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.
Requires a BS degree, or equivalent, in chemistry, biology, biochemistry or equivalent.
BS degree: 2-4 years