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Shire Manufacturing Lead in Lexington, Massachusetts
With minimal supervision this individual will deliver leadership and excellence in manufacturing processing as well as scheduling to meet site demands. Oversees and executes floor operations to ensure safety, aseptic operations and compliance with cGMPs are maintained at all times. Ensures efficient use of material and equipment and assigns personnel as appropriate in the execution of day to day operations. Provide technical support through interactions with support groups to ensure accurate and well managed transfer of process changes/improvements to floor operations. Provide support to integrate best practices, where appropriate, into manufacturing.
Primary contact for troubleshooting and issue resolution or escalation
Create and follow-up on work orders
Communicate/ coordinate days scheduling and staffing plan
Re-allocate staff as needed during the day (breaks, lunch, training, etc)
Oversight and execution of all routine and critical operations as well as commissioning and validation activities
Ensure documentation is complete, reviewed and meets good documentation practices (forms, logbooks, form preps, batch records, etc.)
Responsible for floor inventory and communicating schedule changes as needed
Monitor material consumption and coordinate all materials deliveries
Recommend/Implement process changes/improvements or safety/ergonomic improvements.
Ensure work is carried out in a safe manner, notifying management of safety issues and risks
Responsible for interviewing candidates
Provide timely feedback on staff’s performance
Address minor personnel issues timely
Escalate major personnel issue to the supervisor
Ensure staff compliance with all relevant SOPs, BR, FP and safety guidelines
Act as a role model (Lead by Example) o Act as a resource/SME for staff
Ensure the use of safe work practices and behaviors
Conduct training and assess effectiveness
Help identify training needs
Assess staff skill sets and provide feedback to Supervisor.
Develop training material
Initiate deviations or investigations of various complexities and work with cross-functional departments to identify root cause
Implement appropriate corrective actions
Complete action items for GMP investigations and CAPA’s
Assist supervisor/engineer/facilities with investigations
Revise and author Standard Operating Procedures/Batch Records
Communicate any quality issues/concerns to Supervisor and QA
Education and Experience Requirements:
Normally requires a high school diploma and 6+ years related industry experience or an Associates Degree in Life Sciences/Engineering field with 5 years of GMP Manufacturing experience. Biotech Certificate and prior leadership experience preferred. Experience with systems such as SAP, LIMS and TrackWise is a plus
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shire’s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire will only pay a fee for candidates submitted or presented where there is a fully executed contract in place between the Employment / Recruitment agents and Shire and only if the candidate is submitted via the Agency Portal. Candidates submitted or presented by Employment / Recruitment Agents without a fully executed contract or submitted through this site shall not be deemed to form part of any Engagement for which the Agency may claim remuneration.
Equal Employment Opportunity
Shire is an Equal Opportunity Employer committed to a diverse workforce. Shire will not discriminate against any worker or job applicant on the basis of race, color, religion, gender, gender identity, national origin, ancestry, age, sexual orientation, marital or civil partnership status, pregnancy, gender reassignment, non-job related mental or physical disability, genetic information, veteran status, military service, application for military service, or membership in any other category protected under law.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
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.
Shire is the leading global biotechnology company focused on serving people with rare diseases and other highly specialized conditions. We strive to develop best-in-class products, many of which are available in more than 100 countries, across core therapeutic areas including Hematology, Immunology, Neuroscience, Ophthalmics, Lysosomal Storage Disorders, Gastrointestinal/Internal Medicine/Endocrine and Hereditary Angioedema; and a growing franchise in Oncology.
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.