Manager / Sr Manager, Contract Mfg - United States
- The Contract Mfg Manager 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. Owns contract responsibilities and manages a product within a larger partner.
- Has direct communication with contract site management.
- Responsible for 1-2 small to mid-size CMOs and/or 1-2 product-specific manufacturing processes with a Strategic Partner within the continent
- Teams: Leads matrix teams within a product program. May also drive project initiatives.
- Governance: Drives identification of key business areas that require established governance and leads governance activities.
- Budget: Manages production budget for a product at a contract site and is able to negotiate contract pricing effectively.
- Establishes high performing, stable, compliant and cost effective relationships with CMOs.
- Proactively manages risks/capability and develops mitigation plans. Identifies and communicates risks and issues that impact quality, compliance, project timelines, resource requirements, finances or the overall business relationship.
- Manages contract items from negotiation to termination.
- Defines and ensures that supply level agreements are set and achieved.
- Measures performance of CMOs through implementation and trending of key performance indicators and generates improvements plans as needed.
- Proactively identifies and leads improvement projects covering quality, service, cost and innovation.
- Participates in due diligence activities by preparing needed information.
- 3-6 years of experience in biotech/pharmaceutical manufacturing industry in a technical area (development, manufacturing, manufacturing sciences, etc.)
- Experience working in a GMP regulated environment.
- Demonstrated project leadership skills and ability to develop effective working relationships with internal/external sites and cross-functional project teams.
- Solid project management experience to enable effective management of projects and teams.
- Experience managing project budgets
- Experience creating presentations and presenting to varying audiences.
Bachelors/Masters Degree (Life Science, Quality, Engineering, Business Administration or a related field)
- Through cutting-edge science and medicine, our company discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases.
- Our company 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).
- Our company 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.
- Our company was founded in 1978 and today serves patients in nearly 70 countries.
- 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.
- For nearly two decades our company has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world.
- Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease.
- We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer’s disease, Parkinson’s disease, and ALS.
- As we uncover new insights into human biology, our company is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.
- Our company is revolutionizing biologic manufacturing, developing the industry’s most advanced plants and processes.
- This expertise is used to produce both original innovative therapies and bio similar that expand patient access to lower-cost medicines.
Our Corporate Citizenship
- 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.