Sr Team Leader F&f Gmp Operations

vor 3 Wochen

Bern, Schweiz Johnson & Johnson Vollzeit

**Caring for the world **, one person at a time, inspires and unites Johnson & Johnson. J&J embraces research and science - bringing innovative ideas, products and services to advance health and well-being. Employees of the Johnson & Johnson Family of Companies work with partners in health care to touch the lives of over a billion people every day, throughout the world. J&J has more than 250 companies located in 60 countries around the world.

Are you passionate about crafting a world without disease? Do you have expertise in Health Economics and Market Access? At the Janssen Pharmaceutical Companies of Johnson & Johnson, we use heart, science and creativity to discover groundbreaking medicines. Transforming lives by finding new and better ways to prevent, intercept, treat and cure disease encourages us. We bring together the best minds and pursue the most promising science.

We are looking for a highly committed:
**Sr Team Leader F&F GMP Operations **based in **Bern**

**(Permanent)**

**Further responsibilities and duties are**
- Leading and developing the Fill & Finish Lenti Operations team (currently 13 direct reports) within GMP Operations which includes all manufacturing related activities from pre-clinical to commercial supplies.
- Supervises personnel, and equipment of the team to meet project demands.
- Hires, motivates, develops, and mentors staff to provide employee growth within the team and fosters a culture of continuous improvement.
- Timely delivery of product or intermediate product of the correct quality and quantity to meet project demands.
- Give input to and follow up on departmental goals.
- Provide input in setting the annual departmental budget.
- Define team objectives, translate them into activities and take responsibility for the overall results of those activities.
- Supports technology transfer within the Development organization and cross functional with supply chain.
- Assures that data from CTM manufacturing & Development activities is prepared, analyzed, interpreted and retained accurately.
- Write, review and approve Study Plans & Study Reports.
- Assure that the members of the team keep up to date with developments in own field and are adequately trained; represent own expertise field within and outside Janssen.
- Participates as the F&F production Subject Matter Expert in regulatory inspections and is experienced with the required GMP and regulatory guidelines.
- Maintain and continuously improve cGMP compliance within F&F area, support maintenance and improvement of cGMP compliance within the facility with relation to F&F area.
- Documentation management according to predefined responsibilities (author -reviewer or approver).
- Supporting the Technical Service, Commissioning & Qualification organization to assure that all equipment, rooms, and utilities are qualified for purpose.
- Supporting the MSIT Validation organization to assure that all processes are validated for purpose.
- Collaboration with other departments across Site Bern and external stakeholders.
- Support of LEAN implementation and continuous improvement projects.

**Qualifications**:

- MSc or bachelor’s degree in life sciences with 5-10 years of relevant experience in development and/or manufacturing of pharmaceutical products.
- Several years of experience with leading teams.
- Knowledge and experience of cGMP manufacturing of clinical trial material and/or commercial drug substance/drug product.
- Knowledge of aseptic/filling technology/viral processes.
- SME experience in Fill & Finish area including pilot scale and technology transfer.
- Advanced knowledge of goal setting, leadership, problem solving, communication, mentoring and coaching techniques.
- Knowledge and interpretation/implementation ability of cGMP and current Regulatory Compliance Guidelines.
- Fluency in German and English preferred,

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences.

That is why we in Switzerland are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”

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