Work ScheduleStandard (Mon-Fri)Environmental ConditionsAdherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc allowed, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.)Job DescriptionThermo Fisher Scientific Inc. leads in science services, with over $40 billion in annual revenue. Our goal is to help customers create a better world by supporting various needs.Location/Division Specific InformationLead purification in cGMP manufacturing at our St. Louis site.How Will You Make an Impact?Lead the Biologics unit, drive growth, and launch new therapies for clients and patients.What Will You Do?
Establish Health and Safety Culture: Own and be accountable for establishing a strong health and safety culture within your functional area.
Strategic Direction: Provide daily strategic direction for GMP production at the St. Louis site, ensuring compliance with global cGMP standards.
Technical Transfer and Client Partnership: Partner with clients, manufacturing sciences, process development, and program managers to facilitate technical transfer of client processes to manufacturing, including change controls, batch records, procedures, and training programs.
Staff Recruitment and Development: Recruit and develop staff to complete department functions through strong leadership, performance management, employee development, and recognition practices.
Goals and Performance Indicators: Establish department and individual goals and key performance indicators in alignment with company and operational goals; maintain and report applicable metrics.
Accountability: Drive accountability within your function and other cross-functional teams.
Continuous Improvement: Drive continuous improvement and Operational Excellence culture through self-detecting and self-correcting processes and systems, instilling strong ownership and accountability. Focusing on improving Safety, Quality, Delivery, Cost, and People metrics.
Budget Management: Develop and be responsible for the department’s annual operating budgets; partner with Finance to analyze variances and implement adjustments.
Risk Management: Proactively identify, assess, and mitigate quality, operational, and interpersonal risks; bring up key risks and issues.
Education
Bachelor’s degree with 10-12 years of related work experience, or Master’s degree with 6-8 years of work experience.
Experience
Minimum of 10 years in management/leadership positions, with experience in 2 or more functional areas preferred.
Minimum of 3 years leading cGMP operations teams in a fast-paced production environment.
Demonstrated ability to lead cross-functional teams and collaborate across the business.
Strong analytical and problem-solving skills; attention to detail and excellent decision-making.
Shown proficiency in making complex decisions drawing on data and input from key partners.
Expertise in leading small and medium technical and/or capital projects.
Excellent written and oral communication skills, both internal and external.
Knowledge, Skills, Abilities
Knowledge of working in a regulated environment, with familiarity with cGMP manufacturing and FDA guidelines.
Leadership skills are important for coordinating cross-functional teams and holding others accountable.
Outstanding planning, organization, multitasking skills.
Familiarity with gene therapy vectors and knowledge of local, state, and national regulations for working with biologics is a plus.
Strong verbal and written skills in English required.
Experience in cGMP bioprocess operations.
We offer competitive remuneration, annual incentive plan bonus scheme, healthcare, 401k, and a range of employee benefits!Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation.We offer accommodations for individuals with disabilities during the application process, job tasks, and employment benefits.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.