Work Schedule
Standard (Mon-Fri)
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, Cold Room/Freezers -22degreesF/-6degrees C, No contact lens allowed; prescriptive glasses will be provided, Office, Some degree of PPE (Personal Protective Equipment) required (safety glasses, gowning, gloves, lab coat, ear plugs etc.), Warehouse
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 or the development and manufacture of life-changing therapies, we are here to support them. Our global team of more than 100,000 colleagues delivers 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.