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 in San Diego, CA is seeking a Senior Process Development Chemist. The focus of the Sr. Process Development Chemist is to train junior staff in lab activities, execute Oligo/Reagent process/product transfer into Production and support continuous improvement of existing processes. Sr. Process Development Chemist will serve as Subject Matter Expert in execution of newly developed Oligo and Reagent processes. Sr. Process Development Chemist will perform activities related to new process transfer including DCM, SAP CC, personnel training and will initiate and execute continuous improvement activities of existing processes.

To succeed in this role, we are seeking individuals with a bachelor’s degree and at least 5 years of related experience in a laboratory or commercial manufacturing setting. Individuals with a master’s degree with 2 to 4 years of related experience in a laboratory or commercial manufacturing setting. Candidates must have at least 1 year of Good Documentation Practice (GCD), cGMP, and ISO 13485 regulation experience. We prefer candidates with experience in Oligo Synthesizer and HPLC purification systems.

Primary responsibilities for role:

• Executes and/or oversees notebook, development and validation builds

• Is a subject matter expert on ERP and cycle count transactions

• Independently performs DCM and SAP Change Controls

• Oversees or executes installation and validation of new instruments and equipment

• Executes troubleshooting activities for moderately complex manufacturing processes

• Aides in the design of new qualification protocols and participates in the development of validation document

• Analyzes in-process and final product material using the appropriate analytical equipment

• Independently generates notebook studies and tech reports. This includes product shelf life and hold times

• Completes data gathering and analysis under supervision of scientific staff

• Participates as an extended Operations Core Team member for New Product Development Projects

• Troubleshoots manufacturing processes, instrumentation, IT software related to lab instruments, etc. to develop and improve content

• Assists in process transfers to manufacturing

• Manages simple projects and reports to management on project progress as required

• Uses technical knowledge and independent judgement to provide on-the-spot support to manufacturing to ensure successful completion of builds

• Maintains lab under cGMP conditions

• Maintains accurate records and documents

• 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 (for oligos and reagents) is required

• Manufacturing experience in oligo synthesis and HPLC purification is preferred

• 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

• Demonstrated ability to multitask, prioritize and complete goals

• Demonstrated sound technical knowledge and good independent judgement

Education

• Typically requires a Bachelor’s degree or Master's Degree in Microbiology, Biology, (Bio)Chemistry, Chemical Engineering or related field

• Experience

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

• 2-4 years of related experience in a laboratory or commercial manufacturing setting with a Master'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 up to 10 pounds in weight frequently or continuously.

PayScale

The estimated pay scale for the Senior Process Development Chemist role based in San Diego, California is $83,768.30 to $104,709.80. Additionally, the position is eligible to participate in up to 8% 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.

Learn more about Grifols (https://www.grifols.com/en/what-we-do)

Req ID: 525288

Type: Regular Full-Time

Job Category: Manufacturing