stillingsbetegnelse: Manager, Process Transfer

jobbeskrivelse:
Join a dynamic and international company where everyone is responsible for delivering right on time as one team! We are looking for a Manager to lead and further develop the Process Transfer Team at CMC Biologics A/S (CMC). The Process Transfer Team is responsible for process and technology transfers for early and late phase projects from customers into CMC Biologics and between manufacturing sites. The department The department works at the interphase between customers, the remaining Process Development organization and the Manufacturing organization to oversee and facilitate seamless process transfer processes. The Department is responsible for risk mitigation of the process transfer process and uses various GAP assessment tools in additional to being responsible for the completion of a process transfer package. The department furthermore is responsible for governance of process characterization and validation activities. The work environment in the department is very informal. There is continuous collaboration across the entire organization, and all employees have a very professional and flexible attitude towards their work. The department consists of 6 dedicated and highly competent scientists with different background from development or manufacturing organizations. The Process Transfer Team is in close contact with our counterparts working at our US facility in Seattle and is involved in site transfers between Copenhagen and Seattle. Responsibilities and tasks As the Manager of the Process Transfer Team you play a key role at the interface between customers, Development and Manufacturing. You will play a key role in coordination of cross functional activities at the interphase between development and manufacturing. As the site in Copenhagen is getting ready for commercial manufacturing and associated inspections from regulatory authorities, you will be playing a key role in the preparation and coordination of such activities. You will also be responsible for developing proposals for customized development programs and bio manufacturing solution for potential new customers. As a Team Manager, you will be managing the Process Transfer Team, which includes daily management of your direct reports, tracking of multiple projects, prioritizing activities, assigning resources and tracking metrics, strategic overview, continuous improvements, and exchange of best practices between sites. You will report to the Vice President of Process Development and be a part of the Development Management Team, including responsible managers for the Upstream & Downstream Process Development, and Analytical Development areas. Experience and competencies The ideal candidate holds a PhD in Biochemistry, Biochemical or Chemical Engineering, or related scientific/technical background. In addition to that you have: • Minimum 10 years relevant experience from the industry. • Demonstrated strong expertise within relevant development process transfer area. • A solid understanding of biopharmaceutical manufacturing and GMP. • Minimum 3 years of experience as a manager including people management. • Excellent English written and oral communication is required. On a personal level we expect you to be: • A high performing team player and to be ambitious on behalf of yourself and the company. • You master the balance between speed of execution and quality of work. • You embrace change and enjoy a rapid pace of work in a positive, can-do attitude and with a good sense of humor. • You are experienced with working cross-functionally and internationally. CMC offers CMC offers a dynamic working place with good opportunities of working with a varied array of tasks and challenges. You will get insight into and experience with the way the various departments throughout a Contract Manufacturing Organization interact in order to achieve success. Exciting and challenging assignments will constantly come your way. CMC offers an informal working env

Arbejdsgiver Navn: CMC BIOLOGICS A/S

Arbejdsgiver telefonnummer: 70209470

Job kort beskrivelse:
Arbejde inden for biologi, botanik, zoologi og beslægtede områder

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark