Production Lead, Contract Manufacturing - Switzerland
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|External Posting Title||Production Lead, Contract Manufacturing|
|Job Description||The Production Lead, External Manufacturing manages manufacturing operations with defined scope at CMOs and/or within a CMO site. Responsibilities include commercial and/or clinical supply and tech transfer activities, and providing support to relationship managers within International External Manufacturing. Owns contract responsibilities and manages a product within a larger supply partner relationship. The Production Lead is responsible for direct communication with contract site management on production and production issues. Based on size, may be the single management site lead, if it is a smaller tier 1 supplier. The position is also expected to work closely with internal Biogen groups (Quality, Planning, Sourcing, Manufacturing Sciences, and Technical Development).|
• Primary contact and relationship manager to specified Contract Manufacturing Organization(s) for a single product or for the entire relationship depending on the size and tier of the supplier. This includes managing site performance to BIIB expectations with specific KPIs, ensuring on time in full delivery of all products and projects. It is also expected to assist in implementing the External Manufacturing SRM concept at any site that is managed.
• This position is a member of matrix teams, in some cases may lead matrix teams, to drive projects both internally and externally as it relates to the relevant API, DP, and FG operations. These projects can include activities like Technology Transfers, process optimizations, validation activities, packaging changes, and the associated change management and project management.
• Monitoring and evaluation of CMO key deliveries and performance. Follow up on KPI’s (key Performance Indicators) and ensures the CMO (s) constantly meets standards and expectations for contract obligations, compliance, quality, and production performance and that performance is documented. Responsibilities include monitoring and follow up on Deviations, CAPA’s and Change Requests.
• Responsible for aligning with the internal planning teams to ensure production schedules are maintained with the relevant CMO or supplier.
|Job Category||Manufacturing, Operations, Technology & Innovation (PO&T)|
• Minimum 5 - 7 years of experience in biotech/pharmaceutical cGMP manufacturing industry with supplier relationship experience.
• Experience with both biologics and solids manufacturing including a mix of parenteral filling, API and solids manufacturing and, finished goods production.
• Demonstrated project leadership skills and ability to develop effective working relationships with internal/external partners and cross-functional project teams.
• Excellent communication skills both verbal and written. Ability to communicate at different levels of the organization.
• Fluency in English is a must, any other European language is a plus.
• Bachelors/Master Degree (Life Science, Quality, Engineering, Business Administration or a related field).
|About Biogen||Corporate Overview|
Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer’s disease, Parkinson’s disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.
We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.
The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek’s 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science’s list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.
All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.
Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.
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