Primary Role: 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.
Responsibilities: 60% Processing:
sponsible 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.
velop technical expertise in area of responsibility and provide technical
instruction on new/improved processes to appropriate audiences, primarily
Manufacturing personnel
ll monitor and control labor (absence, vacation and OT) and other group
expenses.
25% People:
sponsible for interviewing and selecting candidates
ovide 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
aining:
o Ensure that staff Individual Training Record (ITRtargets are met
o Schedule and track training attendance
o Evaluate training effectiveness
o Day to day training and coaching employees
15% Quality:
sue deviations or investigations of various complexities and work with
cross-functional departments to evaluate root cause, close them and
implement appropriate corrective actions.
ovide 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
maintained.
vise, author and review Standard Operating Procedures/Batch Records
Education and Experience Requirements Bachelorf Science degree and 2-4 years related industry experience or an equivalent level of education and/or related experience is acceptable.
perience as a Lead or Supervisor in a GMP Manufacturing facility required
perience in executing moderate to complex schedules preferred
perience with systems such as SAP, LIMS and TrackWise is a plus
Key Skills, Abilities, and Competencies
Must possess effective leadership skills
erational knowledge of aseptic technique, clean-in-place (CIP) and steam-in-place (SIP)
and general biopharmaceutical production equipment
owledge of cGMPnd applicable agency regulations (such as the FDA, EMEA) to
ensure inspection readiness of department.
od interpersonal skills and ability to work in a team environment
fective communication skills throughout all levels of the organization
oven organizational and time management skills.
monstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
Complexity and Problem Solving
Responsible for technical problem solving, operational improvements, and efficiency
improvements
ovide technical support through interactions with support groups to ensure accurate and
well managed transfer of process changes/improvements to floor operations.
monstrated application in practical root cause analysis methodologies
Internal and External Contacts
Advises, consults and collaborates with cross-functional teams including but not limited to:
Facilities and Engineering, Manufacturing Sciences and Operations Support, Quality, Validation, PMO Process Development and Health, Safety & Environment.
Notice to Employment / Recruitment Agents:
Employment / Recruitment agents may only submit candidates for vacancies only if they have written authorization to do so from Shirealent 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, 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 pplement - https://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.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.
