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Senior Manager of Quality Control - Biochemistry

Company: Shire Pharmaceuticals
Location: Lexington
Posted on: June 14, 2018

Job Description:

Primary Role:

The Biochemistry Manager will oversee all activities in the Quality Control Biochemistry laboratory. This includes prioritization of testing and managing to standard turnaround times, personnel management and development, method transfer and equipment qualification activities. The individual will also support new projects and continuous improvement activities.

Job Summary/Operations Involvement:

Functions as an advisor to a unit regarding tasks, projects, and operations. Becomes actively involved in daily operations only when required to meet schedules or to resolve complex problems.

Discretion/Latitude:

Erroneous decisions or failure to achieve goals results in additional costs and personnel, and serious delays in overall schedules.

Impact:

Ensures that projects are completed on schedule and within budget. Erroneous decisions or recommendations or failure to complete assignments would normally result in serious delays to assigned projects resulting in considerable expenditure of additional time, human resources, and funds.

Responsibilities:

30-50%:

Management of daily/weekly/monthly and longer term activities of staff and operational oversight of group, data review, scheduling, oversight of group training

20-40%:

GMP documentation related activities (ex. SOP revisions, quality systems related events, method related project documents as required), oversight of group metrics

20-40%:

Involvement in various departmental and cross-functional teams and initiatives; inspection and regulatory support

Specific Biochemistry Focus Areas:

Role is responsible for biochemistry laboratories performing a broad range of techniques such as enzyme assays, PCR, SDS-PAGE, and compendial tests in order to support in-process, release and stability testing. Provides leadership on a daily basis to ensure routine testing is performed within defined turnaround times.

Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.

Maintaining labs in an inspection-ready, GMP-compliant state is critical to this role.

Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.

Role is responsible for biochemistry laboratories performing a broad range of techniques such as enzyme assays, PCR, SDS-PAGE, and compendial tests in order to support in-process, release and stability testing. Provides leadership on a daily basis to ensure routine testing is performed within defined turnaround times.

Role supports commercial and clinical testing for defined site-based and external programs, as well as method transfer and validation. Introduction of new equipment and technology to improve sustainability and compliance is expected.

Maintaining labs in an inspection-ready, GMP-compliant state is critical to this role.

Additionally, the role provides support for Quality projects and implementation of operational excellence initiatives.

Education and Experience Requirements:

Typically requires a minimum of 10+ years of related experience.

Advanced degree in a scientific discipline is preferred, but B.S. degree will be considered depending on overall experience

Additional Specific Experience:

Relevant supervisory experience required.

Excellent communication, interpersonal and organizational skills.

Proactive at keeping current with literature and latest technologies.

Ability to work well both independently and in a team environment.

Ability to prioritize work and multitask.

Conducts work in compliance with cGMPs, safety and regulatory requirements

Other Job Requirements:

Limited to no travel expected. Travel between sites is required.

The following physical abilities are required in order to fulfill the job duties:

-Repetitive bending and reaching to setup and break-down equipment (if required by specific activity)

-Ability to work around chemicals (if working around the laboratories)

-Ability to wear personal protective equipment such as gloves, gowning, and respiratory protection in some cases

-Ability to walk and stand for periods of time

-Individual may be required to participate in environmental chamber monitoring program which would include the use of an on-call mobile phone as well as on-site support during non-business hours

Keywords: Shire Pharmaceuticals, Boston, Senior Manager of Quality Control - Biochemistry, Executive, Lexington, Massachusetts

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