Sr Manager, Manufacturing Sciences

at  Thermo Fisher Scientific

LOCATION

This position will be located at our Fremont, CA location and will support the Niche Diagnostics business which is part of the Clinical Diagnostics Division and the Specialty Diagnostics Group at Thermo Fisher Scientific.
Thermo Fisher Scientific is seeking an experienced and motivated Sr. Manager, Manufacturing Sciences to join our dynamic team. This role is integral to our mission of enabling our customers to make the world healthier, cleaner, and safer.

EDUCATION

• Bachelor’s degree required in a scientific field, preferably in engineering or the biochemistry field with 8+ years of proven work experience. Master’s degree with 6+ years or PhD with 3+ years related experience preferred.

EXPERIENCE

• Minimum 7 years’ previous experience in Manufacturing, Quality, Technology Transfer, or relevant contract manufacturing cGMP regulated environment.
• Minimum 3 years of people leadership experience.
• Previous project management and/or client experience a plus.

KNOWLEDGE, SKILLS, AND ABILITIES

• Strong managerial skills to lead and empower the team, set goals, and provide guidance. It also requires the ability to delegate tasks, conduct performance evaluations, and cultivate a positive work environment.
• Exceptional communication and interpersonal skills to efficiently interact with customers, understand their needs, and drive timely and accurate resolutions to customers’ technical issues.
• Excellent knowledge and understanding of manufacturing/operational processes, Good Manufacturing Practices, Food and Drug Administration (FDA) compliance, and Environmental, Health and Safety (EHS) policies and procedures.
• Shown ability to work across all levels and functions in the organization as well as directly with Customers.
• Proficient in Microsoft Word and Excel.
• Experience in statistical data analysis and understanding data in a statistical perspective will be a plus.
  At Thermo Fisher Scientific, each one of our 100,000 extraordinary minds has a unique story to tell. Join us and contribute to our singular mission—enabling our customers to make the world healthier, cleaner and safer.

• The position is going to develop and empower an impactful team of direct reports to achieve a common set of goals. This team includes managers that support operations and customer complaint handling team.
• Draft, review, and approve Performance Qualifications, Process Validation protocols, process flow diagrams, automation methods, and Bill of Materials, ensuring the process is technically accurate and designed for Manufacturing and procedures are scientifically sound and robust.
• Act as a cross-functional leader and guide leaders and team members in other functions (Operations, R&D, Quality, Regulatory and Product Management) on product process issues and troubleshooting.
• Provide scientific expertise for GMP deviations by assessing, reviewing, and approving the impact of major deviations on both the product quality and the validation of the process or guide the process engineering team and internal teams on product impact.
• Support new business initiatives through client visits and proposal generation.
• Review, analyze, and trend process data without supervision.
• Provide technical feedback on documents crafted by other departments, such as Tech Transfer Protocols and SOPs.
• Develop, propose, and help implement continuous improvement plans for processes and technologies.
• Schedule and lead day-to-day activities in the department as well as prepare and circulate departmental activity reports and schedules, including team metrics.
• Actively identify error proofing opportunities and initiate and drive initiatives to improve practices and procedures without supervision.
• Troubleshoot technical challenges on the manufacturing floor as needed at the facility.
• Mentor, guide and coach the department team from a technical perspective to increase level of knowledge and expertise.
• Select, develop, and evaluate staff to ensure the efficient operation of the function. Recommend changes in staffing and budgets as needed. Staff may include internal and third parties.
• Conduct and lead regular technical meetings with major OEM partners to satisfy customer needs.