Director of Manufacturing Science

Director of Manufacturing Science

Location: CA-San Diego, US Contract Type: Regular Full-Time Area: MANUFACTURING

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.

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.

Position Responsibilities:

• 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

Key Performance Indicators:

• 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, Biology 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 scientists and functional area managers

Excellent time management and project management skills

Expetise in building highly effective teams

Proven success as a leader in a collaborative manufacturing environment

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

The estimated pay scale for Director, Manufacturing Science role based in California, is $199,000.00 - $270,000.00 per year. Additionally, the position is eligible to participate in up to 30% of the company bonus pool. We offer a wide variety of benefits including, but not limited to: Medical, Dental, Vision, life insurance, PTO, paid holidays and 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!