Program Lead, Manufacturing Science - Biogen, Hillerød
Program Lead, Manufacturing Science - Biogen, Hillerød
BIOGEN (DENMARK) NEW MANUFACTURINGApS
- 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 diseases (like ALS and SMA). Moreover Biogen has started phase 3 trials of Aducanumab for the treatment of Alzheimer this was called one of the major groundbreaking innovations of the year in Newsweek in 2015. Further Biogen is one of the frontrunners in the research and production of biosimilars.
With approximately 7,500 people worldwide, Biogen is truly a global organization. Biogen’s European production site in Hilleroed has a pivotal role in the supply of medicine to patients across the globe. The site hosts a large-scale facility for manufacturing biologics, a device assembly, label and packaging facility, an engineering & facilities organization as well as quality control and quality assurance. Biogen in Hilleroed is an exciting workplace for more than 550 employees representing more than 18 different nationalities. At Biogen, science and innovation do not stop in the research lab. Biogen’s capabilities for protein manufacturing are world class in quality and scale and the company is one of a few biotechnology companies with several dedicated biological bulk manufacturing facilities around the globe.
For further information, please visit http://www.biogen.com
The position will be closed as soon as possible, so please do not hesitate to send your application, and always feel welcome to contact SAM Executive Search A/S for further details.
