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Grifols Shared Services North America, Inc Upstream Sr Specialist - 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 Sr Specialist will serve as a subject matter expert in the MS&T Upstream laboratory areas. The main responsibility of the Sr. Specialist is to provide technical expertise in the areas of microbial and mammalian cell culture, process development, scale up and technology transfer, process troubleshooting during routine manufacturing, and process characterization/robustness studies in support of commercialization activities.

Primary responsibilities for role:

● Works with associates with regards to process development, technical support, process monitoring, and optimization/improvement activities for manufacturing

● Ability to lead process technology transfer and scale-up to commercial facilities

● Identifies and reviews data for critical process attributes that can predict process related impacts on products and recommends scientifically sound mitigations to issues.

● Ability to identify and drive Manufacturing Process Improvements

● Support Manufacturing technically in the event of an issue.

● Ability to troubleshoot new and existing product or process issues related to yield, quality and throughput, utilizing structured problem solving techniques and quality assurance mechanisms when appropriate

● Analyze operational data and utilize statistical process monitoring tools to reduce process variability and make technical recommendations

● Work with Quality to conduct comprehensive deviation investigations in the event of failure events to identify root cause and corrective actions.

● Author Product Impact Assessments (PIAs) and Risk Assessments to assist QA in the determination of the releasability of product lots as required

● Own and manage assigned corrective/preventative actions (CAPAs).

● Initiate, own, and manage change control records as required to support departmental projects and assigned CAPAs.

● Author/revise applicable department documentation including Batch Production Documents (BPDs) and Standard Operating Procedures (SOPs).

● Ability to set and meet deadlines, multitask and prioritize resources based on project needs.

● Participate in cross-functional initiatives as necessary and represent the Manufacturing organization and specific department to the rest of Manufacturing and Operations.

● Support Scientists/Engineers with maintaining equipment in labs to ensure efficient performance of activities.

Knowledge, Skills, and Abilities:

  • Knowledge of process scale-up and scale-down methodologies, including process characterization design of experiments

  • Upstream Specific:

o Technical expertise with the upstream mammalian cell culture/microbial derived recombinant proteins and monoclonal antibodies production processes

o Ability to lead efforts for developing and optimizing upstream processes including process parameter optimization, process characterization and scale-up/tech transfer for large scale product production.

o Ability to set up, operate and sample bench-scale/pilot scale bioreactors

o Familiar/experience with different harvesting and cell lysis techniques such as centrifugation/continuous centrifugation (disc stack centrifuge), filtration, dynomill, microfluidzer

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

  • Experience supporting FDA and other Regulatory inspections a plus

  • May be required to work periodically out of normal business hours

  • Must be self-motivated, detail-oriented, collaborative, and able to work effectively in a fast-paced environment.

  • Must be able to work independently, manage multiple priorities, with the ability to prioritize and complete activities on time

  • Demonstrated effective communication, oral and written, in a multi-disciplinary, project-driven work environment.

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

  • Understanding of basic statistical data analysis and a willingness to explore advanced statistical modelling tools.

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

  • Exposure to SAP a significant plus

  • 5S, OpEx, and Lean manufacturing experience a plus

Education:

  • Educational degrees must be relevant to position (e.g., Biology, Microbioloby, or Biochemistry)

  • Minimum Requirements: BS with a minimum of 6+ years’ experience in a regulated biotechnology / medical device industry, or minimum 4+ years’ work experience with a Masters degree

Equivalency:

Depending on the 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. Example: If a job level requires a Bachelor’s degree plus 4 years of experience, an equivalency could include 8 years of experience, an Associate’s degree with 6 years of experience, or a Master’s degree with 2 years of experience.

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: 460068

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