Director Commercial Manufacturing Operations - Marlborough , MA | Biospace
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Director Commercial Manufacturing Operations


Marlborough , MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:
Biology, Chemical Engineering,

Job Description

The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and focused on the development and commercialization of stem cell and regenerative medicine therapies. Astellas is an R&D-driven global pharmaceutical company whose philosophy is to contribute to the improvement of people's heath around the world through the provision of innovative and reliable pharmaceutical products.

Astellas is the bright spot in the pharmaceutical industry -- not just because of what we do, but in the way we do it. If you are looking for a company where you can change a life, make a dream come true, and light the way for a better tomorrow, Astellas is the place where you can shine.

AIRM has a world-class R&D team, and is pursuing a diverse range of disease indications, ranging from macular degeneration (currently in clinical trials) and other ocular indications to vascular and autoimmune disease. AIRM's intellectual property portfolio includes pluripotent stem cell platforms -- both embryonic and induced pluripotent stem cells as well as other cell based therapy research programs. AIRM is headquartered in Marlborough, Massachusetts.


We are seeking a Director Commercial Manufacturing Operations for Regenerative Medicine that will be responsible for developing strategic and tactical plans for manufacturing and supplying of commercial Regenerative Medicine (RM) products and late stage clinical support efforts. This individual will:

•   Assure implementation of initial commercial manufacturing operations for the cell therapy and regenerative medicine business by working in collaboration with AIRM and other stakeholders, cross functionally
•   Establish a commercial supply chain team to achieve goals and objectives for late stage clinical development and commercial stage of RM
•   Demonstrate success in scale up and stable supply of product in late stage clinical trials and commercial launch of RM products which is critical
•   Provide technical input and expertise to cross-functional project teams, creating a competitive advantage through superior service, increased revenue, reduced costs and establishment of an order to cash process within the AUST organization.

Major Duties and Responsibilities:

•   Create a strategic and tactical plan for commercialization of RM products
•   Establish manufacturing capabilities of RM late stage CTMs/commercial products for all Astellas groups
•   Thorough knowledge of development, manufacturing, process automation and distribution for cell therapy production
•   Ensure the necessary supply to support late stage clinical and commercial activities, throughout various stages of development
•   Solid knowledge of regulatory requirements for biopharmaceutical processing, GLP and cGMPs
•   Aligns priorities across functional groups and external contractors / consultants.
•   Obtain GMP certificates for the manufacturing facility from regulatory and local authorities and establish a framework of stable manufacturing of RM late stage CTMs/commercial products
•   Recruit and hire employees for manufacturing RM late stage CTMs/initial commercial products
•   Manage appropriate external contract manufacturing organizations for the supply of RM late stage CTMs/initial commercial products where it is more feasible than internal manufacturing
•   Carry out technical transfer proactively with RM process/analysis development function and scale up to commercialization in RM manufacturing with required level of GMP and stability
•   Support preparation of CTD documentation and NDA submission for RM products in collaboration with relevant functions
•   Strong ability to develop staff through effective coaching and instructing
•   Cross train to establish redundancy within a small team
•   Must have strong collaborative skills and foster team success
•   Requires excellent problem solving skills, and experience leading and managing groups and cross-functional project teams
•   Develop a global supply chain strategy in US, and other regions as necessary
•   Ensure the necessary supply to late stage clinical trials and commercial activities, in the RM business collaborating with Finance, Legal, CMOs, Marketing and Sales
•   Solid knowledge of regulatory requirements for biopharmaceutical processing, GLP and cGMPs
•   Ability to write clear and succinct SOPs for process, equipment, and facility procedures that fulfill operational, compliance and safety requirements
•   Strong interpersonal, supervisory, oral and written communication skills with the ability to create a high level of teamwork and team/individual accomplishment
•   Detail oriented with proven organization and coordination skills in a dynamic situation while maintaining the ability to troubleshoot and 'think outside the box.



•   BS in Biological Science or Biochemical / Chemical Engineering and advanced degree in Science or Business with 7 years relevant biopharmaceutical industrial experience in Manufacturing Science, Manufacturing, Quality and / or Process Development (with cGMP support expertise)
•   Expertise in regulatory requirements and related subjects is essential
•   Experience in understanding and supporting Technical Operations, QC, QA, G&A and HR
•   Knowledge of laboratory and clean room design requirements
•   Experienced in regulatory regulations (FDA, EMA, ISO) and providing direction and support of operational methods and systems
•   Strong background in capital portfolio forecasting, planning, and management
•   Demonstrated ability to build sustainable organizations and to hire, develop, motivate, and retain talent
•   Ability to interact with customers internal and external to Astellas.


•   Proven organization and coordination skills. Ability to manage multiple projects in a dynamic situation while maintaining the ability to troubleshoot and think outside the box.
•   Successful collaboration on multidisciplinary teams; established track record for cross-functional leadership and facilitation
•   Operations management experience in regenerative medicine platforms
•   Knowledge of US and EU aseptic processing regulations as they apply to commercialized cell therapy and regenerative medicine
•   Strong understanding of contamination control and cGMP requirements for facility design and operation.


The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled.