Associate Product Development Chemist - Manufacturing Support

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 place of the stated requirements.

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 of a negligible weight frequently or continuously.

Pay Scale

The estimated pay scale for an Associate Process Group Chemist role based in San Diego, California is $34.50 to $43.13 per hour. Additionally, the position is eligible to participate in up to 5% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, PTO, up to 5% 401(K) match and tuition reimbursement. Final compensation packages will ultimately depend on education, experience, skillset, knowledge, where the role is performed, internal equity and market data. We are committed to offering our employees opportunities for professional growth and career progression. Grifols is a global healthcare organization with employees in 30 countries focused on patient health and providing impactful results. Since our humble beginnings in 1909, Grifols has been a family company that prides itself on its family-like culture. Our company has more than tripled over the last 10 years, and you can grow with us!

Third Party Agency and Recruiter Notice:

Agencies that present a candidate to Grifols must have an active, nonexpired, Grifols Agency Master Services Agreement with the Grifols Talent Acquisition Department. Additionally, agencies may only submit candidates to positions that they have been engaged to work on by a Grifols Recruiter. All resumes must be sent to a Grifols Recruiter under these terms or they will be considered a Grifols candidate.

Grifols provides equal employment opportunities to applicants and employees without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other characteristic or status protected by law. We will consider for employment all qualified Applicants, including those with arrests or conviction records, in a manner consistent with the requirements of applicable state and local laws, including the California Fair Chance Act, the Los Angeles County Fair Chance Ordinance for Employers, and City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Location: NORTH AMERICA : USA : CA-San Diego:USSDW - San Diego CA - Willow Ct Mfg

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