Biopharmaceutical Production Manager: St Louis MO
No relocation package is available for this role. Candidates must be within commuting distance to St Louis
Please make sure your biologics experience is on your resume, if you have no experience in biologics you will not be considered for this role.
Bachelor’s degree required.
- 5-7 years of industry experience in a cGMP environment
- 3-7 years of proven management (leadership and talent development) experience
- Demonstrated success with continuous improvement and a dedication to craftsmanship and putting quality first.
- Understanding of production processes and the biopharma production environment
- Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms
- Understanding of cGMP quality systems (e.g. change control, deviations, investigations, risk assessments, driving GDP within all documentation and records).
- Pro-active, results-oriented attitude
- Strong leadership skills to influence and build effective teams, gain agreement via collaboration, and handle difficult situations with tact and diplomacy.
- Mechanical and technical ability/aptitude
- Analytical problem-solving skills.
- Excellent planning and organizational skills and the ability to efficiently handle multiple tasks, issues, projects.
- Unquestionable integrity, dedication to EH&S and accountable when enforcing teams to follow regulations and procedures.
- Organized, efficient, and results oriented
- Good people coaching and development skills
- Expert in oral and written communication (verbal and written in English), as well as social skills.
- Computer literate with Microsoft Office tools, including report writing and graphing.
- Quality and/or Financial software (SAP, NextDocs, ComplianceWire, etc) skills a plus.
- Manage day to day operations to ensure departmental commitments and deliverables are achieved to meet company objectives. This involves resource oversight, planning, delegation, prioritization, collaboration, etc. for Manufacturing groups.
- Maintain open communication via one-on-one and team meetings, and assure supervisory files are kept up to date.
- Encourage and oversee a culture of compliance regarding Safety, Environmental, Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards / policies. Support all site audits and inspections.
- Ensure adequate manufacturing resources are dedicated to correcting important or critical issues.
- Serve as a leader on departmental and site teams to improve and challenge processes, solve problems, initiate improvements, establish procedures, transfer new products or technologies, execute projects, etc.
- Responsible for working with the Senior Manager to mature area systems on an annual basis.
- 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.
- Be a role model. Exude optimism. Support company direction and officers. Be a supporter and an asset to your peers. Be a representative for Manufacturing on site and back up / delegate for the backup for the area Senior Manager as required.
- Select, develop, and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
Successfully manage departmental manufacturing resources to deliver on customer commitments and expectations.
Ensure right the first time and on time delivery of mammalian cell culture processes and protein purification processes to support clinical and commercial biologics manufacturing.
Demands are to be met in accordance with established safety, quality, efficiency, and regulatory standards.
Oversee all manufacturing resources including personnel and equipment. Operate cross functionally and collaborate with peers both within and outside of department.
Successfully drive disciplined performance management and talent development of direct and in-direct reports. Demonstrating proactive leadership inside of the department and strategic delivery of company goals and a continuous improvement mindset is also an expectation.