Primary Objectives of this Job
With minimal supervision and guidance, 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.
% of Time
Job Function and Description
Responsible for daily operations on the production floor (Cell Culture or Purification), including scheduling, staffing, training, material use and troubleshooting to ensure that all operations are in full compliance with applicable MBRs, SOPs, and safety guidelines.
- Primary contact for troubleshooting and issue resolution or escalation
- Make process decisions, with the help of support roles, including the trouble shooting of equipment, corrective action to process deviations
- Understand operations and contact appropriate support to ensure issues are appropriately resolved
- 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)
- Responsible for area 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 and staff, with guidance from HR or Senior Supervisor
- Provide effective leadership through:
- Provide timely feedback on staff s performance
- Individual goal setting/performance reviews, with guidance from HR or Senior Supervisor
- Address minor personnel issues timely
- Escalate major personnel issue to the Senior Supervisor
- Ensure staff compliance with all relevant SOPs, MBRs 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
- Support Training Compliance through:
- Ensure that Team s Training targets are met
- Help identify training needs
- Schedule and track training attendance
- Evaluate training effectiveness
- Provide training and coaching when necessary
- 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, author and review Standard Operating Procedures/Batch Records
- Communicate any quality issues/concerns to Supervisor and Quality
Staff Technical Training and Development
- Meet and maintain training requirements
- Develop and maintain personal development plan
- Provide annual performance self-assessment on development plan
- Responsibility to adhere to any applicable EHS requirements.
- Commitment to a fair and respectful relationship to others and behavior in accordance with Takeda s Code of Conduct.
- Any other duties as assigned by supervisor.
Education and Experience Requirements
- Degree in Chemical Engineering / Bioengineering / Chemical & Biomolecular Engineering / Pharmaceutical Engineering or equivalent and possesses minimally 4 years of relevant experience in the biotechnology or pharmaceutical industry
- Diploma in Applied Chemistry / Biomedical Sciences / Chemical Engineering / Food Science & Technology / Biologics & Process Technology / Chemical & Pharmaceutical Technology/ Food Science & Nutrition / Molecular Biotechnology / Biotechnology / Chemical & Biomolecular Engineering / Pharmacy Science or equivalent and possesses minimally 6 years of relevant experience in the biotechnology or pharmaceutical industry
- Nitec in Biotechnology / Chemical Process Technology or equivalent with minimally 8 years of relevant experience in the biotechnology, pharmaceutical industry
- Experience as a Lead or Supervisor in a GMP Manufacturing facility required
- Experience in executing moderate to complex schedules preferred
- Experience with systems such as SAP, LIMS and TrackWise is a plus
- Flexibility to work according to the production schedule. This position will require weekend, holiday and overtime work at times
- Knowledge of Lean and Six Sigma methodologies will be advantageous
Key Skills and Competencies
The individual should have little to moderate understanding of general job aspects and some understanding of the detailed aspects of the job.
- Ability to perform manufacturing and sampling operations using aseptic technique
- Basic knowledge of cGMP s and applicable agency regulations (such as the FDA, EMEA) to ensure inspection readiness of department.
- Operational knowledge of aseptic technique, clean-in-place (CIP) and steam-in-place (SIP) and general biopharmaceutical production equipment
- Good interpersonal skills and ability to work in a team environment
- Demonstrates appropriate level of adaptability, maintains positive outlook, and demonstrates composure under pressure.
- Possess effective communication skills to all levels throughout the organization
- Self-motivated individual with the ability to complete and manage multiple floor activities in an effective and compliant manner.
- 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
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.