Manager, Process Manufacturing

Manage cGMP drug substance manufacturing in a state-of-the-art chemical API facility with 130 m3 of total reactor volume and Highly Potent Compound capabilities. Utilize multi-purpose equipment to carry out chemical reactions, isolations, and drying operations to produce intermediates and active pharmaceutical ingredients for both clinical and commercial compounds in a safe and compliant manner.   Manager assignments could include Large Scale Manufacturing, Small Scale Manufacturing, Pilot Plant, HAS Mini-plant, Spray Dryer, or Milling as examples.

EssentialFunctions:

• Manage all technical aspects of pharmaceutical drug substance production, including campaign preparation (e.g.,process fits, process flow diagrams, process hazard analysis, etc.), oversight of daily production (e.g., batch operation of chemical reactions, isolations, drying, etc.), and closeout of manufacturing campaigns (e.g., campaign summary reports, equipment change-over / cleaning, etc.).

• Partner with lab scientists, business managers, and customers to plan campaigns, report results, and improve processes while focusing on the best solutions for our customers success.

• Drive continuous improvement in EH&S/Quality/Efficiency to ensure compliant, right-first-time production.

• Act as equipment and process owner for lifecycle documents such as P&IDs, criticality assessments, Quality Risk Assessments, Qualification/Validation documentation, and EH&S Process Hazards Analysis.

• Oversee production downtime activities including qualification, cleaning, maintenance, and calibration in close collaboration with all relevant stakeholders including Quality, Engineering, Maintenance, and Logistics.

• Oversee relevant compliance activities including discrepancy management, safety and quality investigations, and technical change management.

• Participate in audits and assessments as the Manufacturing representative and account for critical documentation used in regulatory (e.g., FDA, EMA, PMDA), 3rd party, and internal inspections. Define and ensure corrective actions resulting from inspections.

• Lead startup activities for new equipment installations.

• Carry out supervisory responsibilities in accordance with the organization's policies and applicable laws. Responsibilities include interviewing, hiring and training employees; planning, assigning and directing work; appraising performance; rewarding, developing and disciplining employees; addressing complaints and resolving issues.

• Administer, document and maintain the Patheon Quality Systems and tools. Conform to regulatory requirements and company policies where appropriate through effective utilization of Patheon's Quality Systems and tools, as well as direct actions.

Education:

To competently perform this job, a candidate will need the education generally obtained with abachelor’s degree in chemical engineering, Chemistry, or related field.

Experience:

• Eight years’ experience in the pharmaceutical or a related industry preferred.

• Experience in working with process equipment (multi-purpose reactors, centrifuges, dryers, et. al.) and unit operations (liquid separations, filtration, drying, et. al.) commonly used in the manufacturer of small molecule organic compounds. 

• Ensure a safe and compliant work environment.

• Proven record of achievements in a cross-functional environment.

• Demonstrated increase in accountabilities and supervisory responsibilities.

• Experience working in a cGMP environment strongly preferred.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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