Director of Manufacturing Science

About the role

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.

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, including 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 ongoing 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 in MS Office (Word, PowerPoint, Excel).

Key Performance Indicators

• Timely NCR and CAPA closures.
• Ensure projects are completed per project milestones.
• Ensures proper evaluation of impacts of 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.

Requirements

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

Skills

• 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.
• Expertise 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 FDA and other Regulatory inspections.
• 5S, OpEx, and Lean Manufacturing experience a plus.
• Exceptional people management skills.

Pay

The estimated pay scale for the 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.

Benefits

• Medical, Dental, Vision, and life insurance.
• Paid time off (PTO) and paid holidays.
• Up to 5% 401(K) match.
• Tuition reimbursement.