Description 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.
The Manufacturing Supervisor is responsible for overseeing daily activities and personnel on the 1 st and 2 nd shifts in Shire's Milford (MA) Purification production area. Shire's Milford biomanufacturing facility produces Obizur, an FDA-approved biologic treatment for Hemophilia A. In addition to being fully trained in the Obizur production process, the hands-on Supervisor ensures that manufacturing is done in strict compliance with current Good Manufacturing Practices (CGMP), environmental health and safety (EHS) guidelines and any other regulations that may apply.
Due to the production schedule, the work schedule for this position varies month to month. Typical schedule demands are:
- Weekly Monday - Friday, 7:30am - 4:00pm
- 1 to 2 days/month - Monday 6pm - 3am
The weekly schedule does not exceed 40 hours/week and is designed so never to require a night shift followed by a day shift (back to back).
- Hands-on supervision of manufacturing staff including hiring, coaching, goal-setting, professional development, and overall performance management and assessment. Act as a resource and facilitator for all manufacturing employees as needed.
- Complete the necessary training to be able to perform Purification operations on an As Needed basis.
- Support multiple project initiatives, including driving Business Excellence and Continuous Improvement initiatives using Operational Excellence tools and leading metrics.
- Work closely with other Manufacturing groups to align overlapping processes including shared work areas, management of consumables, deviations, corrective actions.
- With Shift Lead s , schedule and allocate department employees, materials, and equipment on a daily basis to support uninterrupted processing of high quality product.
- Author, revise and approve SOP's, batch records, deviations and other documentation as required to ensure compliance.
- Perform real-time review of completed Manufacturing documentation (batch records, forms, etc.)
- Communicate Manufacturing process status with relevant critical data and details to manufacturing management, staff, and other internal departments.
- Support and emphasize the Safety and Quality commitments of the department - make decisions concerning these commitments within the area.
- Facilitate and verify appropriate training for employees in the area (including but not limited to GMP, job skills, safety).
- Ensure compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
Support Manufacturing department during internal and external audits.
- Demonstrated interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
- Strong understanding of GMPs and other regulatory guidelines applicable to commercial pharmaceutical manufacturing.
- Ability to manage multiple priorities in a fast-paced manufacturing plant setting.
- Strong writing skills and ability to prepare technical reports.
- Strong problem assessment and troubleshooting skills.
- Demonstrated ability to interact with all levels of personnel to analyze and solve problems related to manufacturing, Quality, documentation, and personnel issues.
- Ability to analyze data and information to determine paths for process improvement and potential root cause/corrective actions in the case of exceptions.
- Ability to respond to detailed inquiries, and present information to groups with varying levels of scientific knowledge and to senior management.
- Good computer skills including Word, Excel and PowerPoint.
- Flexibility with work schedule to ensure adequate oversight and support for direct reports also required.
Bachelor's degree in a scientific or engineering discipline with previous biomanufacturing experience and demonstrated knowledge of GMP. Previous supervisory or Lead experience strongly preferred. Equal Employment Opportunity
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
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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.
A little about us:
At Shire, we help people with rare diseases and specialized conditions live their lives to the fullest.