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MFG Cell Culture Supervisor LEX- Wed-Sat 1st Shift

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POST DATE 8/18/2016
END DATE 10/27/2016

Shire Pharmaceutical Lexington, MA

Lexington, MA
AJE Ref #
Job Classification
Full Time
Job Type
Company Ref #
Mid-Career (2 - 15 years)
Bachelors Degree


Job Description
Delivers leadership and excellence in manufacturing processing and scheduling to meet site demands. Manages the floor operations to ensure safety and compliance with cGMPs are maintained at all times. Oversees the planning, implementation and maintenance of manufacturing operations for new and/or existing products and technologies in a cGMP environment. Collaborate with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Integrate best practices, where appropriate, into manufacturing. Ensures the efficiency of material, equipment and personnel in day to day operations. Monitor departmental operating expenses (OT, Equipment, Supplies) and assist in developing budgets.

* Responsible for daily operations on the production floor, including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance with applicable MBRs/FPs, SOPs, and safety guidelines.
* Develop technical expertise in area of responsibility and provide technical instruction on new/improved processes to appropriate audiences, primarily
Manufacturing personnel
* Will monitor and control labor (absence, vacation and OT) and other group

* Responsible for interviewing and selecting candidates
* Provide effective leadership through:
o Assess performance and make recommendations for annual programs such as Talent Review and Year End Compensation
o Individual goal setting/performance reviews
o Ensure appropriate staffing levels and skill sets are maintained
o Effectively manage employee performance issues and corrective actions
o Ensure the use of safe work practices and behaviors
o Recognize and appreciate employee contributions and support workforce diversity
o Ensure that employees are working in a safe and compliant manner
* Training:
o Ensure that staff Individual Training Record (ITR s) targets are met
o Schedule and track training attendance
o Evaluate training effectiveness
o Day to day training and coaching employees

* Issue deviations or investigations of various complexities and work with
cross-functional departments to evaluate root cause, close them and implement appropriate corrective actions.
* Provide technical expertise to resolve manufacturing issues and interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.
Ensure operational metrics and business systems (ERP, Inventory) are
* Revise, author and review Standard Operating Procedures/Batch Records

Bachelor s of Science degree and 2-4 years related industry experience or an equivalent level of education and/or related experience is acceptable.
* Experience as a Lead or Supervisor in a GMP Manufacturing facility required
* Experience in executing moderate to complex schedules preferred
* Experience with systems such as SAP, LIMS and TrackWise is a plus

Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We have best-in-class products available in more than 100 countries across core therapeutic areas including Hematology, Immunology, Neuroscience, Lysosomal Storage Disorders, Gastrointestinal / Internal Medicine / Endocrine and Hereditary Angioedema; a growing franchise in Oncology; and an emerging, innovative pipeline in Ophthalmics.

Our employees come to work every day with a shared mission: to develop and deliver breakthrough therapies for the hundreds of millions of people in the world affected by rare diseases and other high-need conditions, and who lack effective therapies to live their lives to the fullest.

Shire is an equal opportunity employer. Shire evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.

EEO is the Law
EEO is the Law - Supplement
Pay Transparency Policy

Reasonable Accommodations
Shire is committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please call 484-595-8400 and let us know the nature of your request and your contact information.