Thermo Fisher Scientific Manager, Production (Suite 3-Downstream) in St. Louis, Missouri
How will you make an impact?
The Manager, Production (Downstream) successfully manages departmental resources in order to deliver on customer commitments and maximizing the full potential of our employees. Demands are to be met in accordance with established safety, quality, efficiency and regulatory standards. This involves oversight of all resources including personnel, equipment, and capital. Collaborative interaction with peers both within and outside of department is necessary for success. Successfully driving disciplined performance management and talent development of direct and in-direct reports is critical to this role. Demonstrated proactive leadership inside of the department and strategic delivery of company goals and a continuous improvement mindset is also an expectation, as is a deep understanding and hands-on experience with mammalian production processes (Downstream) within the clean room environment and associated quality systems to make appropriate tactical decisions balancing cost, quality and risk analysis.
What will you do?
Make decisions as a Subject Matter Expert on mammalian large scale production processes (Downstream protein purification unit operations).
Coordinate a production schedule spanning up to seven production suites, while increasing production capacity through de-bottlenecking processes and optimizing systems. The platform equipment involves both SS perfusion bioreactors and Single-use Bioreactors up to 2000L in a multi-product USP ballroom with adaptable and cutting edge DSP systems capable of processing up to 10kgs of product.
Co-lead a growing team of supervisors and manufacturing bioprocess technicians while managing day-to-day operations and ensuring departmental commitments and deliverables are achieved to meet company objectives. This involves resource oversight, planning, delegation, prioritization, collaboration, etc. Accountable for cost center P&Ls.
Establish departmental and individual expectations, provide direction and balanced performance feedback, coach, develop, and challenge direct reports, enforce company policies, and deal with personnel issues promptly. Maintain open communication via one-on-one and team meetings, and assure supervisory files are kept up to date.
Encourage and enforce a culture of compliance regarding Safety, EH&S, Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards/policies. Support all site audits and inspections. A leader and champion for site compliance.
Ensure adequate resource is dedicated to correcting important or critical issues via personal involvement, delegated resources, and/or appropriate escalation. This often involves collaborative interaction with other departments.
Represent as a leader on departmental and site teams to solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc. A representative for Manufacturing on site and back up / delegate for Sr. Manager, Production or Director, Manufacturing as required.
Conduct hiring, oversee training, prepare and communicate staff evaluations. Develop a team that is highly respected, engaged, and actively develop and train high potential candidates for the next generation of leaders. Serve as a mentor to develop other leaders across the site.
Be a role model. Exude optimism and be a Change leader. Support company direction and officers. Be a supporter and an asset to your peers. Be proactive and hold peers across the site accountable as well.
Select, develop and evaluate staff to ensure the efficient operations of the function. Work with and advise staff on administrative policies and procedures.
How will you get here?
- Bachelor’s or Master’s degree in a scientific field.
7-10 years of biopharmaceutical industry experience required, preferably in a cGMP environment
Experience in Operations and knowledge of biotech cGMP systems and relevant process unit operations (e.g. cell culturing, protein purification)
3-5 years of prior experience as a supervisor
Sound technical, hands-on Downstream process knowledge and expertise in the pharmaceutical industry, including pharmaceutical regulations from FDA, EU, ICH and PICs guidelines.
Knowledge, Skills, Abilities
Knowledge of pharmaceutical cGMP systems and relevant process unit operations (i.e. upstream cell culture, downstream purification, single-use systems, QC and analytical) and operation within a cleanroom facility that is FDA-approved.
Solid understanding of quality management systems (deviations and events, investigations and CAPAs, change control etc.).
Demonstrated strong leadership skills to influence and build effective teams, gain agreement via collaboration, and handle difficult situations with tact and diplomacy.
Pro-active, results-oriented attitude.
Excellent planning and organizational skills
Exceptional oral and written communication skills, as well as social skills.
Demonstrated ability to lead and develop a team and department staff members to act upon their goals and objectives with minimal direction.
Ability to drive accountability through effective coaching and feedback.
Demonstrated ability to thrive in a fast-paced environment
Ability to work independently or as part of a team.
Able to efficiently handle multiple tasks, issues, and projects.
If you are an individual with a disability who requires reasonable accommodation to complete any part of our application process, click here at https://jobs.thermofisher.com/page/show/eeo-affirmative-action-statement#accessibility for further assistance.
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.