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Sr Manager, Manufacturing
2 months ago
Other
Environmental Conditions
Office
Job Description
Exciting Opportunity:
Thermo Fisher Scientific Inc., a leading company in the scientific research and manufacturing sector, is looking for a skilled Senior Manager, Manufacturing to join the team in Austin, TX.
As a key figure in this role, you will play a crucial part in providing expertise in qPCR and sample preparation reagent manufacturing for our GSD and BID divisions, making a substantial impact.
Your responsibilities will involve identifying and executing improvement projects, ensuring compliance with ISO 13485 and USDA regulations, and promoting operational excellence.
A Typical Day:- Coordinate daily manufacturing operations for qPCR and sample preparation reagent manufacturing, including planning capacity and managing budgets.
- Manage a team of supervisors and scientists, guiding them to cultivate a culture of continuous improvement and goal achievement.
- Establish and enhance operational objectives and metrics, evaluating results during Quarterly Business Reviews.
- Act as a backup and potential successor for the Operations Director during audits, tours, and tier meetings.
- Strive for the highest level of compliance in manufacturing and in-process testing methods.
- Lead initiatives to introduce new technologies, equipment, methods, and validations.
- Train, support, and organize operations team members to meet or surpass departmental standards and key performance indicators.
- Offer manufacturing leadership, guidance, and backing across the organization, encouraging cross-functional collaboration and communication.
- Implement process enhancements using PPI, 5S, Lean, and Six Sigma techniques, actively identifying and executing improvement opportunities with the team and internal clients.
- Support internal, external, and regulatory inspections, acting as the primary manufacturing operations contact.
- Achieve production, quality, financial, staffing, and EHS objectives and targets, ensuring operational success.
Education:
- Candidates must possess a Bachelor's degree in biological sciences, chemistry, engineering, or related fields. Equivalent experience will be considered. A Master's degree is preferred, and a PhD is a bonus.
- Minimum of 10 years experience in a manufacturing role within the biological and/or pharmaceutical industry.
- At least 7 years of leadership/management experience in an ISO 13485 or USDA-regulated environment is desired.
- Preferably holds certifications in Six Sigma, supply chain, and project management, e.g., MBA, CSSBB, CPIM, and PMP.
- Thorough understanding of qPCR and sample preparation methodologies, with a preference for quality analysis knowledge.
- Experience with ISO9001, ISO13485, and USDA regulatory standards is advantageous.
- Proficient in leading and collaborating with cross-functional teams.
- Proven ability to prioritize and lead complex processes/projects, including new product launches.
- Strong presentation skills, capable of effectively communicating information to employees, top management, and various audiences.
- Familiarity with software and custom programs to address business requirements; familiarity with SAP and other business software is beneficial.
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