Associate Process Development Chemist - Manufacturing Support

Would you like to join an international team working to improve the future of healthcare? Do you want to enhance the lives of millions of people? Grifols is a global healthcare company that since 1909 has been working to improve the health and well-being of people around the world. We are leaders in plasma-derived medicines and transfusion medicine and develop, produce and market innovative medicines, solutions and services in more than 110 countries and regions.

Grifols Diagnostic Solutions Inc in San Diego, CA is seeking an Associate Process Development Chemist to support our Manufacturing Support team. The main responsibility of the Associate Process Development Chemist is to support process transfer activities such as notebook/development/validation lots, manufacturing reagents, transcripts and oligos following cGMP guidelines and maintaining laboratory activities under supervision.  The Associate Process Development Chemist will assist senior staff in material reservation for oligo and/or reagent builds, label printing, bulking, filling and packaging following draft Manufacturing Instructions.  The Associate Process Development Chemist will perform documentation updates and provide support to manufacturing.

 

To succeed in this position, we are seeking individuals with a bachelor’s in science or equivalent in Chemistry, Biology, Biochemistry, or equivalent along with 2-4 years of related experience in a laboratory setting and 1-2 years of GDP, GMP, and ISO 13485 required.

 

This role also has a variable shift requirement. We are seeking candidates open to 1st, 2nd, and possibly 3rd shift.

 

Primary Responsibilities:

• Provides support to Manufacturing Sciences/Support senior staff. 
• Assists in the development of manufacturing processes to transfer oligos and/or reagents/sub-assemblies to Manufacturing. 
• Participates in process validation protocols with supervision. 
• May assists with simple Change Controls. 
• May assist in the development of manufacturing processes. 
• Participates in cost savings and process improvement activities. 
• Participates in notebook, development, validation and commercial builds per written directions.
• Maintains lab under cGMP conditions. 
• Completes ERP and cycle count transactions. 
• Stocks and maintains lab supplies. 
• Keeps accurate records and documents with supervision. 
• Manages Calibrated Equipment in the lab. 
• Performs some equipment maintenance per procedures. 
• Provide support for manufacturing process. 
• Author and update documents to support process improvement, CAPA, Validations, and general updates. 

 

Additional Responsibilities:

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

 

Knowledge, Skills, and Abilities:

• Working knowledge of cGMP/GLP, proficiency in Microsoft Office
• Working knowledge of the appropriate analytical techniques (either for oligos or reagents) and technical knowledge is required
• Manufacturing experience in oligo synthesis and HPLC purification is preferred.
• Strong math and analytical thinking skills
• Willing to take initiative and handle multiple priorities at the same time.

 

Education:

Requires a BS or equivalent in chemistry, biology, biochemistry or equivalent.

 

Experience:

2-4 years of related experience in a laboratory setting with a Bachelor’s degree

1-2 years of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is required

 

Equivalency:

Depending on area of assignment, directly related experience or a combination of directly related education and experience and/or competencies may be considered in