Process Development Chemist

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.

Summary:

The main responsibilities of the Process Development Chemist is to support oligo and/or, reagent, and transcripts builds following cGMP guidelines, assist senior staff in process/product transfer into Manufacturing and assist in continuous improvement of existing processes.  The Process Development Chemist will manufacture oligos and/or reagents, will create draft Protocols and Manufacturing Instructions, and will complete simple documentation Change Control using ERP systems (SAP and DCM).

Primary responsibilities for role:

• Executes and trains junior staff on material reservation for oligo and reagent Manufacturing Sciences/Support activities. 
• Executes and trains junior staff on fulfilling lab supplies and cleaning on weekly basis. 
• Initiates and completes cycle count transactions on monthly basis. 
• Performs notebook, development, pilots, validation and commercial builds per GMP guidelines for reagents/sub-assemblies builds. 
• Acts as checker on GMP manufacturing processes. 
• Executes the process validation protocols for reagents/sub-assemblies builds. 
• Completes transfer to Manufacturing including training activities. 
• Installs and validates new instruments or equipment. 
• Initiates simple to moderate level Change Control using ERP systems (SAP and DCM). 
• Assists in the development of manufacturing processes to transfer oligos and/or reagents to Manufacturing. 
• Writes Protocols and Manufacturing Instructions.   
• Orders lab/department supplies through corporate ordering system (SRM). 
• Maintains lab under cGMP conditions.
•  Maintains accurate records and documents. 
• Managers and supervisors may assign other duties as needed.

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, basic Change Control
• Working knowledge of the appropriate analytical techniques (either for oligos or reagents) is required
• Manufacturing experience in oligo synthesis and HPLC purification is desired
• Development and Problem-Solving experience in oligo synthesis and/or purification is preferred 
• Ability to effectively and actively communicate with cross-functional partners (e.g., Supply Chain, Manufacturing Sciences, Warehouse)
• Ability to train junior personnel effectively
• Good organizational skills and attention to detail
• Team oriented, attentive and willing to learn new processes
• Demonstrated technical writing skills
• Ability to write, review, mark-up and format documents in Word

Education:

Typically requires a bachelor’s degree in Microbiology, Biology, (Bio)Chemistry, Chemical Engineering or related field.

Experience:

4+ years of related experience in a laboratory or commercial manufacturing setting with a Bachelor’s degree

1 yr of experience with Good Documentation Practices (GDP), Current Good Manufacturing Practices (cGMP) and ISO 13485 Regulations is preferred experience with oligo synthesizers and HPLC purification systems is preferred

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 the Process Development Chemist role based in San Diego, CA is $78,683 to 98,353.75 per year. 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 in a manner consistent with the requirements of applicable state and local laws.

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

Learn more about Grifols