stillingsbetegnelse: Program Lead, Manufacturing Science, Biogen (DK)

jobbeskrivelse:
- Attractive opportunity for a strong Tech Transfer profile As Program Lead/SME in Manufacturing Sciences (MS) - Device, Label and Pack, you will be responsible for coordinating and managing Technology Transfer activities and projects for both local and global programs You will manage all aspects from readiness, over execution to lessons-learned and provide clear project management leadership during the entire process. Your main areas of work will be: 1) Life-cycle management of commercial products: •Lead global process changes •2nd and 3rd line support for production floor in Hilleroed in case of potential product impact •Support in Audits and Inspections •SME/support on critical technical investigations, deviations, CAPAs, Supplier and CMO deviations, equipment/process changes, Vendor Change Notifications etc. 2) Project/Program Leadership: •Leadership and coordination of activities coming to/from site Hilleroed to external CMOs. •Leadership of/support to other major process change projects internally and at CMO’s 3) Continuous Improvement: •Partner with Technical Development for device development in relation to manufacturability •Partner with Global Pack Development for packaging platform development and standardization •Harness data-driven process analytics and structured problem solving including coaching to others •Support LEAN culture with a view to COGS improvement You will be partnering with all relevant line functions, including but not limited to Technical Device and Pack Development USA and CH, QC&QA, QM, CMC, Operations, Engineering and New Product Launch leads to ensure a coordinated approach to tasks and projects at hand across Biogen. The position reports to the Sr. Manager, MS. CANDIDATE PROFILE We are looking for a profile with solid experience from a biopharm-/pharmaceutical or medtech manufacturing environment who really knows how to manage highly complex tech transfer projects in Device Assembly and Finished Goods from development to product launch. You probably possess most of below skills and characteristics: Professional Qualifications: •At least 6 years of project management/SME experience from Device Assembly and Finished Goods manufacturing •Strong background in mechanical engineering and high volume automation •Experience in molding/assembly of molded components •Strong background in Design for Manufacturing, and Lean/Six Sigma practices •Strong background in inferential statistics, Statistical Process Control, Design for Manufacturing, Lean/6sigma practices a strong asset for this position Personal Qualifications: •High performing team player, ambitious on behalf of yourself and the company •Exceptional interpersonal skills including the ability to influence behaviors, negotiate and resolve challenges with calm, tact and diplomacy •Master the balance between speed of execution and quality of work •Well-developed organizational skills and an analytic mindset •Thrive on working cross-functionally and internationally •Embrace change and enjoy a rapid pace of work •Positive and can-do attitude As you will work in a multicultural environment Good English oral and written communication skills to all functional levels are mandatory. ABOUT BIOGEN Biogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, autoimmune diseases and hemophilia. As a company, Biogen recognizes that cutting-edge science and medicines can change the course of devastating diseases.Founded in 1978, Biogen is the world’s oldest independent biotechnology company. Their development pipeline is one of the strongest in the industry and patients worldwide benefit every day from their industry leading multiple sclerosis (MS) products. Biogen works hard to bring new therapies to market for patients with serious neurodegenerative, non-malignant hematologic and autoimmune diseas

Arbejdsgiver Navn: BIOGEN (DENMARK) NEW MANUFACTURINGApS

Arbejdsgiver telefonnummer: 77416000

Job kort beskrivelse: Ingeniørarbejde i industri og produktion

land: Danmark

region: Hovedstaden

Kontrakt varighed: Fast

Kontrakttype: Fuldtid

krævede uddannelse: Ikke angivet

Kilde til jobtilbud: AMS, Offentlige arbejdsformidlinger, Danmark