Technical Operations Manager (MSAT)

thermo fisher biopharma services pte. ltd.; Singapore; On-site; SGD 90,000 - 130,000; Full time

Job summary

Thermo Fisher Scientific Inc. is seeking a seasoned professional to lead and manage a technical operations team in Singapore.

You will oversee quality, safety, and performance targets, while guiding development plans and cross-functional collaboration to support NPI and commercial production. The role emphasizes strong GMP knowledge, process quality investigations, change controls, and CPV/APR activities, with a focus on sterile pharmaceutical manufacturing.

Qualifications

• Minimum Bachelor's degree in engineering, biological/chemical sciences or related disciplines.
• 3 to 6 years of Pharmaceutical experience is preferred; people managing experience is preferred.
• Strong knowledge of GMP, CPV and APR processes and their application in manufacturing.

Responsibilities

• Oversee and coach the technical operations team; establish priorities for the department and site.
• Develop robust development plans to grow the team.
• Lead and manage quality investigations, change controls and CAPA activities.
• Provide technical expertise for NPIs and existing products; support for process development and qualification activities.
• Ensure compliance with EHS standards; monitor safety and process safety activities.
• Act as technical approver for critical documentation and process changes.

Skills

Pharmaceutical processes

GMP knowledge

Statistical process controls

Problem solving

Leadership

Team mentoring

Open to change

Sterile injectable production exposure

Packaging & visual inspection

Education

Bachelor's degree in engineering or sciences

Job description

How Will You Make an Impact?

Thermo Fisher Scientific Inc. (NYSE: TMO) is the world leader in serving science, with annual revenue of approximately $40 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer.Whether our customers are accelerating life sciences research, solving complex analytical challenges, increasing productivity in their laboratories,improving patient health through diagnostics orthedevelopment andmanufacture of life-changing therapies, we are here to support them. Our global teamofmore than 100,000colleaguesdelivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, Invitrogen, Fisher Scientific, Unity Lab Services, Patheon and PPD. For more information, please visit www.thermofisher.com.

What will you do?

The incumbent will lead and manage a technical operations team, to meet the 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

• Must provide oversight, coaching of the technical operations team and work effectively with cross-functional teams in establishing priorities for technical operation department and site. Must provide technical and quality and safety guidance to their team to manage the activities.

• Manager is expected to development the team with robust development plans.

• Accountable for ensuring team is highlighting the problem, making the results visible and addressing the issues systematically and scientifically.

• Provides oversight for technical support for NPI (New Product Introduction) or existing product by supervising and coaching the team in development studies, cleaning process development and qualification activities of products and processes, re-qualification activities and quality investigations.

• Demonstrate in-depth knowledge of change controls, cleaning validations, qualifications and process performance trending and reporting.

• Responsible to lead complex and/or significant quality investigations and change controls. Will be a change owner.

• Will be a technical approver for quality investigations, validations/qualification protocols/reports, risk assessment, change controls and other technical documents, where applicable.

• Responsible to author technical Operations protocols, reports and other documentations related to existing product or NPI at site.

• Act as point of contact and mentor to guide engineers to manage NPI, quality investigation and complaints, CPV, problem solving and statistical and problem-solving tools.

• Provide technical expertise for day-to-day production activities of commercial products, e.g. Support in identifying root causes of problems; changes and improvements to processes; implementation of new production technologies etc.

• Provides technical expertise for quality compliance activities (for e.g. documentation update to batch records, SOPs, risk assessments etc), change control, investigations and CAPA and support for health authorities' inspections.

• Proactively supervise and approve Continuous Process Verification (CPV) and Annual Product Review (APR) activities to trend, monitor and analyze and adjust and shift in process parameters, critical quality attributes (CQAs) and process and equipment performance.

• Participates in critical technical projects related to the production of commercial sterile pharmaceuticals.

• Ensures that new products/processes introduced into production are robust and efficient. It follows and supports from a technical point of view or the engineering and validation batches in order to ensure the robustness and efficiency of the transferred processes.

• Participation in project meetings, aimed at transposing the production processes requested by the customer, the approval of the instructions regarding production operations, any support in the event of anomalies with respect to production standards.

• Demonstrate and promote EHS safe practices as per safety standards SOPs. Ensure all the activities are carried out as per EHS standard and site safety SOPs. Participate in safety activities, HAZOPS and process safety activities related to the product at site

• Any other duties assigned by manager.

How will you get here?

Education

• Minimum Bachelor's degree in engineering, biological/chemical sciences or related disciplines

Experience

• 3 to 6 years of Pharmaceutical experience is preferred. People managing experience is preferred.

Knowledge, Skills, Abilities

• Pharmaceutical manufacturing processes

• Knowledge of GMP

• Knowledge of Statistical Process Controls and related tools

• Good computer skills

• Knowledge of laws and regulations relating to safety and conservation of the environment

• Flexibility, Leadership and Relationship skills

• Openness and attentive

• Specific experience in the production of sterile injectable drugs is preferred

• Specific experience in packaging and visual inspection activities is preferred.

• Highly motivated to work in pharmaceutical Industry.

• Able to work as a team.