Job Title: Manager/Associate Director
FLSA Status: Exempt
Job Number: 11290907 (CO20)
Department: Chemical Operations
Description: Manage API manufacturing operations in a state-of-art GMP kilo-lab and pilot plant equipped with Delta V controls and high containment systems.
Essential Duties and Responsibilities:
- Provide input to development chemists regarding commercial feasibility and safety of new chemistry routes
- Perform cost calculation for pilot plant and projected manufacturing cost based on small scale data and information
- Develop Master Batch Records with development team for execution in the plant
- Demonstrate expertise of cGMP concepts
- Develop work plan and shift schedule for 6 operators
- Manage raw material inventories necessary to accomplish multiple campaigns
- Improve work process efficiency by analyzing existing SOPs and best practices and identifying areas of improvements or as necessary develop new work process to address unmet needs
- User to expert level in Delta V process control software
- Familiar with typical analytical equipment used in pilot plant manufacturing (HPLC, GC, FTIR, KF, LOD, DSC, PXRD, and NMR)
- Demonstrated ability to analyze data from plant runs and apply such analytical approach in writing effective technical reports such as campaign reports and development reports
- Understanding of unit operation equipment typically utilized in small molecule synthesis (reactors, condensers, filters, separators, dryers, and mills)
- Experience in interacting with Process Chemists, Analytical Chemists, EH&S, QA, QC and Facilities
Job Requirements:
Education: BS Chemical Engineering or Chemistry.
Experience: 5+ years ideally in the pharmaceutical industry.
Specific Skills: Managing cGMP chemical manufacturing of APIs and intermediates.
Supervisory Responsibilities: Yes.
Physical Demands/Work Environment: This position requires the large majority of the time spent in an office environment, sitting, keyboarding and talking on the phone, and may also require other office related activities. Some time may be spent in the laboratory (generally less than 10%) where certain hazards such as radioactivity and biohazards are present.
