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:Job Function and % of Time
- 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)
- 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
- Provide training
- 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
Key Skills, Abilities, and Competencies
- Ability to perform manufacturing and sampling operations using aseptic technique
- Operational knowledge of Clean-in-Place (CIP) and Steam-in-place (SIP) Systems and general production equipment such as Autoclaves, water baths, pH/Conductivity meters etc.
- Knowledge of cGMP s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
- Good interpersonal skills and ability to work in a team environment
- Effective communication skills to all levels throughout the organization
- Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
- Self motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner. In the absence of the supervisor they are the person of authority.
- Expected to act on behalf of the supervisor while on the floor
- Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times.
- Ability to wear personal protective equipment such as safety glasses/goggles, gloves and safety shoes.
- Ability to gown and gain entry to biotechnology/pharmaceutical manufacturing areas.
- Ability to lift, pull or push equipment requiring up to 25-50 lbs of force.
- Ability to stand for 6 hours in a production suite.
- Ability to climb ladders and work platforms.
- Stooping or bending to check or trouble-shoot equipment operations.
- Ability to work around chemicals (alcohols, acids & bases).
Complexity and Problem Solving
- The incumbent will be responsible for technical problem solving and recommending efficiency and/or operational improvements.
- Required to make process decisions, with the help of supervision and support roles, including the trouble shooting of equipment, corrective action to process deviations.
- Individual will be required to understand operations and contact appropriate support to ensure issues are appropriately resolved.
Internal and External Contacts
- All Internal Manufacturing, Materials Management Facilities Management and Health, Safety & Environment with limited exposure to support groups (Validation, Quality Control, etc).
- Will require minor external contact with equipment and supply item vendors.
Other Job Requirements
Prior experience or exposure in the following activities required:
- Standardization and measurements utilizing bench top equipment
- Aseptic processing
- Cell culture inoculation and scale up processes
- Use of bioreactors and centrifuges in the growth of cell cultures
- Process automation
- SAP Enterprising Resource Platform
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, a wholly-owned subsidiary of Takeda s Talent Acquisition department. Any agency candidate submission may only be submitted to positions opened to the agency through the specific Agency Portal. Shire, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda 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, a wholly-owned subsidiary of Takeda, is an Equal Opportunity Employer committed to a diverse workforce. Shire, a wholly-owned subsidiary of Takeda, 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.
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Pay Transparency Policy - https://www.dol.gov/ofccp/pdf/pay-transp_formattedESQA508c.pdf
Shire, a wholly-owned subsidiary of Takeda, 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.