Assoc Manager Usp Gmp Operations

Vor 4 Tagen

Bern, Schweiz Johnson & Johnson Vollzeit

Johnson & Johnson, through its operating companies, is the world's most comprehensive and broadly based manufacturer of health care products, as well as a provider of related services, for the consumer, pharmaceutical, and medical devices and diagnostics markets. We strive to provide scientifically sound, high quality products and services to help heal, cure disease and improve the quality of life.

Assoc ManAger USP GMP Operations (M/F/D)

(Ref: 2406221161W)

YOUR responsibilities & YOUR impact:
Aim of this role
- Leading and developing the USP 2x10L Lenti Operations team within GMP Operations which includes all manufacturing related activities from pre-clinical to commercial product supplies

General Activities
- 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.
- Management of team and responsible for the development of staff, performance of appraisals and have key role in recruitment of new hires.
- 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 GMP manufacturing & Development activities is prepared, analyzed, interpreted and retained accurately
- Write, review and approve Study Plans & Study Reports.
- Key role in writing study plans, study reports, MBRs, SOPs
- 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 USP production Subject Matter Expert in regulatory inspections and is experienced with the required GMP and regulatory guidelines.
- Maintain and continuously improve cGMP compliance within USP area; support maintenance and improvement of cGMP compliance within the facility with relation to USP area.
- Documentation management according to predefined responsibilities (author -reviewer or approver)
- Communication with internal and external parties for raw material supply as well as for purchasing and commissioning of new equipment
- Supporting the TS C&Q 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 VPAD Bern and VPAD Leiden and DPDS departments and external stakeholders
- Support of LEAN implementation and continuous improvement projects
- Active participation in the improvement of cGMP compliance, process excellence and process development aspects of CTM manufacturing
- The Sr Team Leader is the deputy for the Manager of GMP Operations for their related departmental topics
- 2x 10 L USP team members

**Qualifications**:
We would love to hear from YOU, if you have:
Essential
- MSc or bachelor's dree in life sciences with 5-10 years of relevant experience in CMC development, manufacturing of Parmaceutical products
- Knowledge and experience of cGMP manufacturing of CTM and/or commercial drug product
- Knowledge of USP technology/viral processes and aseptic processing

Key competencies required
- SME experience in USP area including pilot scale and technology transfer
- Several years of experience with leading teams
- 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 English and German preferred

This is what awaits YOU at J&J:

- An opportunity to be part of a global market leader.
- A dynamic and inspiring working environment.
- Many opportunities to work on challenging projects and assignments.
- Possibilities for further personal as well as professional development.
- Many employees benefits.

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