Successfully manages departmental resources in order to deliver on customer commitments and expectations. Ensure right the first time and on time delivery of process equipment, associated tubing and filter assemblies, documentation, buffers and media, as well as deliver ISO-Class cleaning to support clinical and commercial biologics manufacturing. Demands are to be met in accordance with established safety, quality, efficiency and regulatory standards. Oversees all departmental resources including personnel, equipment, and capital. Operating cross functionally and collaborating with peers both within and outside of department is necessary for success. Successfully drives disciplined performance management and talent development of direct and in-direct reports is critical to this role. Demonstrates proactive leadership inside of the department and strategic delivery of company goals and a continuous improvement mindset is also an expectation. Has a deep understanding and hands-on experience with GMP manufacturing processes within the clean room environment and associated quality systems (deviation event writing and investigations) to make appropriate tactical decisions balancing cost, quality, and risk analysis.
- 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 Production Support, Buffers and Media, and Manufacturing Systems Support.
- 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, Environmental, Quality standards as required by cGMPs, Health Authority regulations, government agencies, and company standards / policies. Support all site audits and inspections.
- Personally ensure adequate resources are dedicated to correcting important or critical issues via personal involvement, delegated resources, and/or appropriate escalation. This often involves collaborative interaction with other departments, especially Supply Chain, Quality, Process Development and Engineering/Facilities.
- Recognized 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.
- 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. Serves as a mentor to develop other leaders across the site.
- 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 Director, Manufacturing as required.
- Live the Thermo Fisher Scientific 4Is values every day. Be proactive.
- Select, develop and evaluate staff to ensure the efficient operation of the function. Work with and advise staff on administrative policies and procedures.
Education and Experience:
- Bachelor degree required
- 7-10 years of industry experience, preferably in a cGMP environment
- 5-10 years of proven Management (leadership and talent development) experience
- Knowledge -
- Understands production processes and the biopharma production environment
- Excellent understanding of cGMP and other regulatory requirements in the operation of cleanrooms
- cGMP quality systems (e.g. change control, deviations, investigations, risk assessments, driving GDP within all documentation and records).
- 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.
- Mechanical & technical ability/aptitude
- Analytical problem solving skills.
- Excellent planning and organization skills and ability to efficiently handle multiple tasks, issues, projects.
- Unquestionable integrity, dedication to EH&S and accountable when enforcing teams to follow regulations and procedures.
- Demonstrated success in driving quality systems and leading change with continuous improvement and a dedication to craftsmanship and putting quality first.
- Good business decisions using both cost and risk analysis
- 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.
- Abilities -
- Strong leadership and resourceful
- Lead change
- Reliable, accountable and disciplined.
- Handle multiple tasks, issues, projects
- Work independently or as a part of a team, distill and solve issues to deliver analytical and strategic solutions.
- Handle difficult situations with tact and diplomacy
- Distill and solve issues
- Build agreement via collaboration
- Ability to drive functional, technical and operational excellence.
- Ability to inspire and foster innovation, collaboration, transparency and team effectiveness.
- Able to sit, stand, walk, lift, push, pull
- Able to gown per cGMP requirements and work in a gowned condition for extended periods of time in a cleanroom environment (including various temperatures and noise conditions)
- Able to work with chemicals and don appropriate PPE
- Able to work potentially long, flexible hours and be reachable for consultation 24 hrs. per day.