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Grifols Shared Services North America, Inc DIRECTOR, MANUFACTURING SUPPORT 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:

Provides strategic and tactical leadership for the Manufacturing Support Department and is accountable for providing technical input and support for the manufacture of existing blood screening products, receiving and implementing tech transfer for major process changes and new products, troubleshooting manufacturing issues and making improvements to the existing manufacturing processes. Manages functional areas of Oligonucleotide Development, Product Support, Pilot Plant, Tech Writing, and Product Engineering functions.

Primary responsibilities for role:

  • Develops MS strategies and roadmap for implementing process/equipment improvements and troubleshooting existing process issues.

  • Is the SME for the overlap of process, equipment, manufacturing technique and underlying science in the products we manufacture

  • Provides technical and scientific input into cleaning and process validations, NCR investigations and ongoing training of manufacturing personnel.

  • Leads the tech transfer from R&D and successful implementation into full-scale manufacturing production, include process development, when required

  • Leads the engineering and full scale investigation runs required for NCR investigations, process / equipment changes.

  • Provides guidance in evaluating process improvements and/or modifications between existing Manufacturing operations and key project teams.

  • Responsible for both internal and external manufacturing project initiatives

  • Ensures projects are implemented successfully, on time and within budget.

  • Provides on-going coaching to staff and measures team effectiveness

  • Drives continuous improvement and other projects (functional and cross-functional) as needed

  • Collaborates with the Team in lowering the cost of goods for manufactured products, maintains cost center and project budgets

  • Proficient MS Office (word, power-point, Excel)

Knowledge, Skills, and Abilities:

  • Timely NCR and CAPA closures

  • Ensure projects are completed per project milestones

  • Ensures proper evaluation of impacts or any process related changes.

  • Ensures that processes are in a state of control (KPI trends)

  • Ensures that major manufacturing processes have a robust life-cycle management program (including emphasis on process robustness and economics) in place

  • Ensures that there exists a suitable balance between the resourcing for commercial manufacturing support, technology transfers and process stewardship in line with Grifols Divisional expectations

  • Successful technology transfers and technical manufacturing support of the site

  • Adherence to agreed financial budgets and cost of goods targets

  • Yield and reject targets met

Education:

B.Sc., M.Sc. or Ph.D. in Biochemical or Chemical Engineering, Biology or related discipline

Experience:

  • 15 years of industrial experience with B.Sc/M.Sc. or ≥10 years of experience with Ph.D. in Biochemical or Chemical Engineering, Biol-ogy or related discipline

  • Minimum of 8 years supervisory experience

  • Extensive experience working on multiple overlapping projects with complex interactions and a track record of completing projects on time and successfully.

  • Must have previously led a successful department of technical staff.

  • Knowledge of cGMP environments and Lifecycle process and cleaning validation requirements

  • Excellent communication skills, especially technical writing and presentations

  • Excellent skills in leading discussions of data with peers such as sci-entists and functional area managers

  • Excellent time management and project management skills

  • Expertise in building highly effective teams

  • Proven success as a leader in a collaborative manufacturing envi-ronment

  • Builds strong working relationships with cross-functional stakeholders and co-workers

  • Previous experience supporting FDS and other Regulatory inspections

  • 5S, OpEx and Lean Manufacturing experience a plus

  • Exceptional people management skills

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: 317027

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