Quality Control Manager, Analytical, Technical Operations - Astellas - Marlborough, MA | Biospace
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Quality Control Manager, Analytical, Technical Operations - Astellas

Astellas

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Location:
Marlborough, MA
Posted Date:
7/25/2017
Position Type:
Full time
Job Code:
1750041093
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:

Job Description

The Astellas Institute of Regenerative Medicine (AIRM) is a wholly-owned subsidiary of Astellas Pharma and is 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.

Description:

AIRM is seeking a highly motivated individual to join us as a Quality Control Manager, Analytical. This position plays a key role in managing Quality Control (QC) product testing and method validation functions in support of AIRM's program goals and regulatory submissions.

•   Must work cooperatively with Analytical Development, Manufacturing, Regulatory and Quality Assurance departments
•   Individuals experienced with cell culture, RT-qPCR, Immunofluorescence, Flow Cytometry and cell based assays preferred.

Essential Responsibilities:

•   Oversees overall day-to-day work operations in the QC Analytical lab; in-house and external product testing across product lines, associated support lab functions, and ensures documentation completed in accordance with cGMPs
•   Partners with analytical development to achieve method readiness to initiate validation, write validation protocol, gather and interprets data generated by analytical development/QC labs and writes/reviews validation reports
•   Participates in execution of method validations and transfers within and outside of AIRM
•   Interacting with contract laboratories to support sample testing, data analysis and investigations as required
•   Oversees QC equipment validation, maintenance and calibration, and QC laboratory scheduling and maintenance
•   Establish personal and QC analytical group goals to meet deliverables based on issued objectives
•   Author and approve SOP's, protocols, reports, data summaries and quality systems internally as well as at CROs and CMOs
•   Monitor and trend QC data; complete routine record review of test data and related documents for in-process testing, drug substance and drug product release and stability testing
•   Collaborate with regulatory to support IND/NDA/MAA filings/amendments on CMC sections
•   Support regulatory PAI and GMP inspections in a global environment
•   Implement GMP systems in QC and ensure compliance with documented policies
•   Interacts with all levels of management on a routine basis and will oversee the development of the QC Analytical function
•   Works on complex and diverse problems giving guidance and suggestions
•   Actions may have implications on operations, budget and credibility.

Requirements

Requirements:
   
Required:

•   PhD, MS or BS in Molecular Biology, Chemistry, Pharmaceutical Sciences, Life Sciences or equivalent
•   PhD + minimum 5 years or MS/BS + minimum 10 years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry
•   Excellent knowledge of cGMP, ICH, USP and global compendial regulations and guidance
•   Possesses a positive, can-do attitude and creatively solves problems.

Preferred

•   PhD
•   Individuals experienced with cell culture, RT-qPCR, Immunofluorescence, Flow Cytometry and cell based assays
•   QC experience in the biotech and/or pharmaceutical industry.

Disclaimer

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.