Description
GMP Team Leader USP/DSP JOB DESCRIPTION:supervises Process Engineers & Technicians PURPOSE OF THE JOB Responsible for defining objectives and activities related to GMP production within the process development department. Supervises those activities, personnel and equipment of the department to meet project demands. Main accountabilities (6-8) of the Jobholder
Responsibility:
* 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.
* Supervision of the team and responsible for the development of staff, performance of appraisals.
* 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 other parties.
* Assures that data from CTM manufacturing 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 of the organization.
* Participates, as the USP/DSP production Subject Matter Expert, in regulatory inspections and is experienced with the required GMP and regulatory guidelines.
* Pilot plant representative in global & cross-functional scientific project teams.
* Maintain and continuously improve cGMP compliance within USP/DSP area; support maintenance and improvement of cGMP compliance of pilot plant facility with relation to USP/DSP area.
* Working Relationships and Contacts Strong cross- functional interaction with the other Team Leaders, the Development & Investigations team and with other site Bern departments and with the Scientific Leads at the Sites in Bern.
Dimensions:
The TL USP/DSP leads a department of approx. 4 FTEs Required education & relevant experience Master's degree with 5-10 years of relevant experience in CMC development of Biologics Knowledge and experience of cGMP manufacturing of CTM and/or commercial drug substance SME experience in USP/DSP area ("Anaerobic" Fermentation, Centrifugation and Ultrafiltration) including pilot scale and technology transfer. Several years' experience with leading teams. Advanced knowledge of goal setting, leader ship, problem solving, communication, mentoring and coaching techniques. Knowledge and interpretation/implementation ability of cGMP and current Regulatory Compliance Guidelines
Non-Technical profile requirements:
Some flexibility in working hours is required - Must be able to work on multiple simultaneous tasks with limited supervision; - Quick learner, motivated self-starter; - Excellent customer service, interpersonal, communication and team collaboration skills; - Able to follow change management for internal guidelines.
Language proficiencies: English and Swiss German spoken and written;
Passport: please do only apply with a european passport or a valid work permit
Please send me your CV,
Bests,
S. Keel