Manufacturing Operations Manager

Work Schedule

12 hr shift/nights

Environmental Conditions

Adherence to all Good Manufacturing Practices (GMP) Safety Standards, Cleanroom: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair etc... allowed, Office

Job Description

As part of the Thermo Fisher Scientific team, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. We provide our global teams with the resources needed to achieve individual career goals while helping to take science a step beyond by developing solutions for some of the world’s toughest challenges, like protecting the environment, making sure our food is safe or helping find cures for cancer.

The incumbent will lead and manage a manufacturing team, to meet the production objectives and targets of the assigned department in terms of quality, quantity, time, cost and safety. The incumbent shall lead by example and maintain high standards of quality, cGMP, Safety and Occupational Health for the team.

Responsibilities:

Following will be the responsibilities:

Production

• Supervise and co-ordinate the production personnel under their team and ensure that the production schedule, output targets, yield efficiencies and satisfactory quality products are achieved in timely manner. 

• Plan the team's activities to ensure that all processes are adequately manned in order to achieve the production requirements with minimal disruption to work-flow or process consistency. 

• Participate in process hand-over in an efficient, clear and concise manner. Process should be hand-over in a safe state as well. 

• Develop, revise and review SOPs as needed to cover routine production activities. 

• Lead in team training and development, to function as one professional team.

• Verify that each shift delivers process documentation that is thorough and accurate.

• Responsible for the notification and problem resolution process related to production and assist in production investigation especially those associated with process deviations. Front line to troubleshoot any process / equipment problems and to take action to prevent re-occurrence.

• Lead/participate in activities to instil continuous improvement mindset in the Operation team.
• Maintain high standard of housekeeping and general facility maintenance in the plant at all times.
• Liaise with maintenance Manager or relevant team member for all maintenance matters, ensuring that equipment is properly prepared and isolated, that proper permits have been Issued and that proper supervision and capabilities are present. Ensure that all maintenance activity is coordinated with production plans as far as possible
• Develop, revise and review cleaning batch sheets, and other process-related documents. Support and assist in projects, technology transfers and other non-routine activities.
• Assist in the recruitment of appropriate caliber staff
• Supervise and oversee Third Party Contractors, where applicable.
• Any other duties as and when assigned by the Manager.

Quality

• Responsible to maintain the quality compliance posture of the team and confirming the team is always in compliance with company quality standards, via supervision of the team, following the application of SOPs and procedures and the definition of corrective actions. 

• Participate in audit and inspections.

• Responsible for timely batch record review and submission to QA.

• Liaise with Quality Control Department with regard to samples and tests, receipt and Interpretation of test results, and resolution of inconsistencies.

Safety

• Responsible for compliance with the company Environmental, Health and safety rules and regulations by all operations employees, employees outside direct supervision, and visitors to the production areas.

• Be aware of and promote awareness of the safety and risk of hazardous nature of the chemicals, equipment and processes in the area, ensuring appropriate precautions are observed.

Knowledge, Skills, Abilities:

• Good understanding of cGMP requirements of Biologics/Pharmaceutical plants

• Good understanding of process and having continuous improvement mindset

• Leadership

• Excellent interpersonal and communication skills 

• Able to work in shifts.

Education:

• Degree/Diploma in Science/Pharmaceutical/Engineering or relevant field

Experience:

• Advanced degree plus 6 years of experience, or Bachelor's degree plus 8 years of experience, in cGMP manufacturing environment, preferably in pharmaceutical or diagnostic manufacturing
• Minimum 5 years as people manager, in pharmaceutical industry. Aseptic processing experience will be preferred. 

• For Diploma candidate, minimum 6 years of people manager experience is required.