Quality Control Manager, Microbiology, Technical Operations - 1750042164 - Marlborough, MA | Biospace
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Quality Control Manager, Microbiology, Technical Operations - 1750042164

Astellas

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Location:
Marlborough, MA
Posted Date:
8/11/2017
Position Type:
Full time
Job Code:
1750042164
Salary:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

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.

Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture. There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.

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, Microbiology. This position plays a key role in managing Quality Control (QC) Microbiology laboratory operations, personnel, microbiology product testing, validation and environmental monitoring program in support of AIRM's program goals and regulatory submissions.

We are looking for strong experience with implementing an environmental monitoring program and hands-on experience with implementing endotoxin, sterility testing and microbial identification in a QC environment.

Essential Responsibilities

* Oversees overall day-to-day work operations in the QC Microbiology lab; in-house and external product testing across product lines, associate support lab functions, and ensures documentation completed in accordance with cGMPs
* Oversee the environmental monitoring (EM) program at AIRM and lead alert/action limit excursion investigations
* Monitor and trend EM data and update management on environmental trends. Implement corrective action plans when necessary
* Implement microbial identification program using Vitek with required validation within QC Microbiology function
* Implement sterility testing program at AIRM using BacT with required validation within QC Microbiology function
* Implement endotoxin testing at AIRM with required validations within QC Microbiology function
* 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 Microbiology group goals to meet deliverables based on issued objectives
* Autho 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
* This position interacts with all levels of management on a routine basis and will oversee the QC Microbiology function
* Works on complex and diverse problems giving guidance and suggestions
* Actions may have implications on operations, budget and/or credibility

Requirements

Required

* PhD, MS or BS in Microbiology or equivalent
* PhD + minimum 3 years or MS/BS + minimum 10 years of relevant experience in QC or equivalent experience in commercial pharmaceutical industry
* Demonstrated successful management of Environmental monitoring, Personnel monitoring in manufacturing suites, Gowning and Aseptic Qualifications and QC Microbiology labs
* Strong experience in developing Microbiological assays, (Sterility, Mycoplasma, Endotoxin, Morphology, Gram Stain and Microbial Identification) and managing testing by compendial methods
* Possesses a positive, can-do attitude and creatively solves problems

Preferred

* PhD
* Individuals experienced with implementing environmental monitoring programs
* QC Microbiology experience performing and validating endotoxin assay and sterility testing in the biotech and/or pharmaceutical industry
* Implementing a microbial identification program using Vitek
* Excellent knowledge of GMP, ICH, USP and global compendial regulations and guidance

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.

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