Shire Manufacturing Lead in Cambridge, Massachusetts

Primary Duties:

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.

Responsibilities

70% Processing

 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

 Carry out work in a safe manner, notifying management of safety issues and risks

20% People

 Responsible for interviewing candidates

 Provide timely feedback on staff’s performance

o Address minor personnel issues timely

o Escalate major personnel issue to the supervisor

o Ensure staff compliance with all relevant SOPs, BR and FP

o Act as a role model (Lead by Example)

o Act as a resource/SME for staff

o Ensure staff are working safely at all times

 Training

o Conduct training and assess effectiveness

o Help identify training needs

o Assess staff skill sets and provide feedback to

Supervisor.

o Develop training material

o Provide training

10% Quality

 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

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, 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.

EEO is the Law - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf

EEO is the Law – Supplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCPEEOSupplementFinalJRFQA508c.pdf

Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf

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.

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.