The Patheon St. Louis site is a multi-product and multi-client biopharmaceutical site with manufacturing facilities for pharmaceutical products for both (pre)clinical trials and commercial applications. The technologies used are industry standard to state of the art. The St Louis facility complies with the cGMPs prescribed by the FDA and other global regulators, as well as the internal and external EH&S requirements and regulations. The production activities must be executed in an efficient and effective manner to assure overall compliance, competitiveness and customer satisfaction.
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.
The Manager, Production (Downstream) is responsible for overseeing a high-performing clinical manufacturing team performing the following activities:
- 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 Patheon 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 10+ supervisors and 60+ 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.
- Personally 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.
- Recognized 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. Live the Thermo Fisher Scientific 4Is values every day. 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.
Education & Experience:
- Bachelor’s or master’s degree in a scientific field with 7-10 years industry experience (preferably in a cGMP environment) or equivalent combination of education and experience in a (bio) pharmaceutical company.
- Experience in operations and knowledge of biotech cGMP systems and relevant process unit operations (e.g. cell culturing, protein purification).
- 5-10 years of proven management experience
- Demonstrated leadership skills
- Sound technical, hands-on Downstream process knowledge and expertise in the pharmaceutical industry, including pharmaceutical regulations from FDA, EU, ICH and PICs guidelines.
- Unquestionable integrity, dedication to EH&S and accountable.
- Demonstrated success in driving quality systems and leading change with continuous improvement and a dedication to craftsmanship and putting quality first.
- Possess a pro-active, results-oriented attitude and display strong leadership skills to influence and build effective teams, gain agreement via collaboration, and handle difficult situations with tact and diplomacy.
- Work independently or as a part of a team, distill and solve issues to deliver analytical and strategic solutions.
- Excellent planning and organizational skills and ability to efficiently handle multiple tasks, issues, projects.
- Expert in oral and written communication, as well as social skills. Computer literate with Microsoft Office tools. Quality and/or Financial software (SAP, NextDocs, ComplianceWire, etc) skills a plus.