Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cold Room/Freezers -22degrees, Loud Noises (Equipment/Machinery), Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Strong Odors (chemical, lubricants, biological products etc.), Will work with hazardous/toxic materials
Job Description
Job Title: Sr. Manager, Manufacturing Sciences
When you're part of the team at Thermo Fisher Scientific, you'll do meaningful work, that makes a positive impact on a global scale. Join 100,000 colleagues who bring our Mission to life each day to enable our customers to make the world healthier, cleaner and safer. You'll find the resources here to achieve your career goals and help take science a step beyond by developing solutions for some of the world's toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.
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.
How will you make an impact?
This position is a strategic partner in manufacturing operations owning the technical product support team to achieve required business results. The Senior Manager will ensure and support products are manufactured with the highest level of quality and compliance in a safe and timely manner that will meet customer expectations while meeting all cost commitments. This leader will interact with all areas and levels of the company, using a multi-disciplinary approach to problem solving and will report to the Sr. Director, Operations.
As the Sr. Manager, Technical Operations, you will provide leadership and technical directions in the areas of manufacturing processes and technology, raw material qualifications, process improvement, and quality performance for commercial batches, assistance in the pre-commercial lots run by Operations and technical support for the execution of clinical diagnostics projects. You will lead the Technical Operations team, providing mentorship and develop their skills and increase their expertise.
Key Responsibilities:
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.
Qualifications:
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 experiencepreferred.
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.
Apply today! http://jobs.thermofisher.com
Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.
Benefits
We offer competitive remuneration, annual incentive plan bonus, healthcare, and employee benefits. Thermo Fisher Scientific employs an innovative, forward-thinking organization and outstanding career and development prospects. We offer an exciting company culture for integrity, intensity, involvement, and innovation!
Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
Compensation and Benefits
The salary range estimated for this position based in California is $X-$X.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
Compensation and Benefits
The salary range estimated for this position based in California is $141,800.00-$212,000.00.
This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:
A choice of national medical and dental plans, and a national vision plan, including health incentive programs
Employee assistance and family support programs, including commuter benefits and tuition reimbursement
At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount
For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards
