Shire Regenerative Medicine's Brave culture offers employees with diverse backgrounds the opportunity to enable those with life altering conditions to lead better lives.
Shire Regenerative Medicine develops and commercializes living cell therapies, a cornerstone technology in the field of regenerative medicine. Shire Regenerative Medicine participates in the rapidly growing diabetes market through the manufacturing and marketing of its lead cell-based therapy, Dermagraft®, a bio-engineered skin substitute that assists in restoring damaged tissue and supports the body's natural healing process. Dermagraft is FDA approved to treat diabetic foot ulcers and is the focus of an ongoing pivotal trial for the treatment of venous leg ulcers.
The Manufacturing Supervisor, Growth Systems is responsible for the commercial manufacturing cell culture growth activities in the production of Drug Substance (mammalian based tissue for packaging) in an FDA approved cGMP cleanroom manufacturing facility. The growth group is responsible for inoculation, expansion and sustained production of Drug Substance (mammalian based tissue for packaging).
Oversees the planning, implementation, and maintenance of events and equipment used in the growth area. Provides leadership and knowledge to meet plant cell production requirements, and interacts with groups such as MTS, Engineering, Facilities, Calibration, Validation, and Quality to ensure accurate, well managed, and compliant operations.
Supervises the floor operations to ensure safety, compliance, and aseptic operations. Ensures the effective use of materials, equipment, and personnel during the production of high quality products and services. Monitors and controls labor (absenteeism, vacation, overtime, etc.) and other group expenses.
Directly supervise a group of 6+ employees. Lead tissue growth floor activities and assignment of roles in the tissue growth area to ensure timely completion of tasks in a GMP plant. Interact with support groups to ensure production targets are met and product and process comply with cGMPs, product licenses and corporate policies.
Provide technical expertise to resolve manufacturing issues in the tissue growth area. Ensure that operations and documentation conform to cGMP standards and that all SOPs and Batch Records are maintained to reflect current manufacturing methods. Utilize technical writing skills to initiate quality event reports as required. Ensure that training is maintained current, and that quality events and CAPA’s related to product quality and/or disposition are addressed and closed in a timely manner.
Develop team capabilities and enable continued staff development. Uphold and maintain clear and consistent performance management practices and expectations.
Maintain a safe work environment. Ensure Safety and Housekeeping audits are conducted. Ensure that Departmental Safety Training is performed and current.
Represent growth department in support of plant cross functional sub-teams meetings such as: Project Teams, Safety, and Tactical Operations Team. Lead efforts to communicate and address daily atypical events reporting.
A Bachelor’s of Science degree in a life science or other technical area, or an equivalent level of education and / or experience. Requires a minimum of 4-5 years of prior work experience, including 1-2 years in a lead or supervisory capacity, in a GMP Manufacturing facility (Biotechnology or Pharmaceutical industry).
Experience with cell culture operations and familiarity with execution of moderate to complex scheduling activities is highly desired.
Key Skills, Abilities, and Competencies:
• Must possess the ability to inspire and motivate a manufacturing team through leadership and implementation of effective management tools.
• Must understand the needs of key collaborators and internal customers, and interact effectively intra- and interdepartmentally to achieve alignment.
• Must be responsible and accountable for delivering functional area objectives on time and within budget.
• Must be self-motivated and driven to independently establish and accomplish departmental goals and objectives.
• Must possess solid technical writing and presentation skills.
Complexity and Problem Solving:
Incumbent will be required to make, or at times appropriately delegate, process related decisions such as with trouble shooting of equipment, root cause analysis, developing corrective actions for deviations, change control management, material dispositions, and scheduling adjustments.
Internal and External Contacts:
Interacts regularly with Manufacturing plant internal customer and support groups such as the following:
• Central Services(Solution Prep, Production Support), Cell Expansion, Packaging
• Warehouse and Distribution
• Planning and Scheduling
• Engineering and Facilities
• Quality Assurance and Quality Control
In addition, effective collaboration with business partners from Human Resources and Finance is expected.
Other Job Requirements:
Incumbent will be provided with a mobile phone device and is required to make be available as needed in order to support plant operations. May be required to push vessels and lift up to 40 lbs. Holiday work is required in order to provide support to the team.
We are an Equal Opportunity and Affirmative Action Employer.
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