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Grifols Shared Services North America, Inc Process Development Chemist in San Diego, California

Do you want to join an international team working to improve the future of healthcare? Do you want to improve the lives of millions of people? Grifols is a global healthcare company which, since its foundation in Barcelona in 1909, has been working to improve the health and well-being of people all over the world. Our four divisions - Bioscience, Diagnostic, Hospital and Bio Supplies - develop, produce and market innovative medicines, solutions and services in more than 100 countries and regions.

Summary:

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.

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 documents

  • 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

Additional Responsibilities:

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 inplace 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.

EEO Minorities/ Disability/Veterans

Grifols is committed to Equal Employment Opportunity (EEO) and to compliance with all Federal, State and local laws that prohibit employment discrimination on the basis of race, color, age, national origin, ethnicity, religion, gender, gender identity, pregnancy, marital status, sexual orientation, citizenship, genetic disposition or characteristics, disability or veteran's status or any other classification protected by applicable State/Federal laws. We will consider for employment all qualified Applicants, including those with Criminal Histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance.

Req ID: 277127

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