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Grifols Shared Services North America, Inc Analytical Manager MS&T in Emeryville, 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 Analytical Manager will lead a team of analytical scientists and will have primary oversight of the MS&T laboratory function where suitable process assays would be defined and qualified as appropriate in support of process development, scale up and technology transfer, process troubleshooting during routine manufacture, and process characterization/robustness studies in support of commercialization activities.

Primary responsibilities for role:

  • Lead a team of 8-10 scientists (B.S. to Ph.D. level) and will be accountable for resource allocation, project scheduling and prioritization, and scientific data review including data integrity verification, statistical analysis and technical report writing.

  • Demonstrate hands-on technical leadership in the laboratory, oversee and delegate experimental/project responsibilities as needed, and write/review development summary reports and author sections of regulatory submissions as required

  • Review/comment the documents for analytical method development reports, method qualification/ transfer protocols and reports, specifications, test results, stability protocol/report and investigation report to support the development/testing of recombinant protein products

  • Collaborate with upstream and downstream MS&T teams to develop and deliver manufacturing processes that meet the yield and product quality requirements of the development programs.

  • Work closely with QC department to assure the quality of analytical methods and provide technical comments for troubleshooting, OOS/OOT investigations and deviations.

  • Maintains laboratory facilities and equipment in accordance with company policies and industrial best practices.

  • Create an environment of strong team spirit, timely and effective communications, sense of urgency, high motivation and inspire teams to achieve goals in the immediate and longer term. Be an active and visible change agent, promoting flexible and open mindsets to new opportunities.

Knowledge, Skills, and Abilities:

  • Technical expertise in analytical (development and qualification) methods used for recombinant proteins and monoclonal antibodies.

  • Has advanced knowledge and technical experience of analytical techniques such as SDS-PAGE, HPLC, Amino Acid Analysis, ELISA's and in vitro diagnostic test kits, Lowry, Bradford, Western Blotting, Mass Spectrometry, Dynamic Light Scattering, and Differential Scanning Calorimetry (DSC).

  • Demonstrates an understanding of above techniques and able to troubleshoot methods, techniques and evaluate criteria for obtaining results and interpreting experimental outcomes.

  • Ability to introduce new/modern analytical techniques that can reduce times and increase throughput

  • Independently applies sound scientific principles in development of innovative solutions to complex technical problems. Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.

  • Demonstrates critical judgment and strategic thinking sufficient to represent functional area concerns on cross-functional teams.

  • Working knowledge of cGMP environments (understanding of equipment, technology, and quality systems requirements)

  • Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required.

  • Proficient with the use of MS Office software (MS Excel, MS Word, MS Powerpoint) and application software including Unicorn, JMP, Minitab, Design Expert etc).

  • Direct expertise with Lean, 5S, Operational Excellence

Education:

  • BA/BS degree in chemistry, biology, engineering or related field with 12 years of related experience. MS + 10 years’; PhD + 8 years.

  • Minimum of 8+ years of GMP experience including 4+ years of supervisory or team leadership experience.

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: 242087

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