Job Description

Job Description

Chemical Operator – Malvern, PA

The Chemical Manufacturing Operator is responsible for the batch-wise manufacture of active pharmaceutical ingredients in a safe and GMP compliant manner. The Chemical Manufacturing Operator carries out tasks associated with chemical manufacturing utilizing batch logs, standard operating procedures, and work instructions under cGMP guidelines. The Chemical Manufacturing Operator adheres to all safety, quality, and compliance regulations, procedures, and guidelines, with special care given to protect the environment in which we operate.

• ESSENTIAL DUTIES AND RESPONSIBILITIES: Complies with company policies and procedures, established safety procedures, and maintains a safe and clean working environment.
• Manipulate the equipment and reactors in the pilot plant to complete chemical reactions and isolations.
• Assist with or lead the manipulations in the kilo lab to complete successful scale up campaigns.
• Assist with or lead the manipulations in the highly potent compound suite to complete successful scale up. This includes gowning up, using PAPR respirators, and following strict guidelines and SOPs for safely operating in the suite.
• Oversees manufacturing process composed of steps such as set-up, loading, unloading, processing, drying, documentation, and follow-up.
• Accurately completes batch logs and other documentation to produce product efficiently and in compliance with cGMP and standard operating procedures.
• Proper operation of process controls, pneumatic, hydraulic and electrical equipment as detailed in procedures to product materials in a safe and cGMP environment.
• Recognizes and documents “abnormal” operating conditions with proper response including immediate notification of supervision.
• Inspects components and products of the production cycle for compliance with applicable standards.
• Makes good use of hold periods for subsequent processing steps. Utilizes idle processing time to perform other production related activities (housekeeping, lean initiatives, training, etc.)
• Participate in safety evaluation meetings and process development discussions with process chemists to provide feedback and support successful scale up.
• Collaborate with analytical chemists, process chemists, and QA to ensure successful completion of campaigns and release of raw materials, intermediates, and final products.
• Clean and assist in maintaining the equipment in the pilot plant and kilo lab.
• Coordinate removal of hazardous waste

• QUALIFICATIONS, EDUCATION, and/or EXPERIENCE High school diploma or general education degree (GED).
• Work experience in a chemical and/or pharmaceutical environment.
• Five or more years related experience and/or training or equivalent combination of education and experience.
• Mechanical aptitude of production equipment and processes
• Use computer software applications including Microsoft office suite
• PHYSICAL DEMANDS While performing the duties of this job, the employee is regularly required to stand, walk, climb, band, and stoop. The employee uses hands to handle and feel and must reach with hands and arms.
• The employee frequently is required to talk, hear, taste, and smell.
• The employee must occasionally lift and/or move up to 50 pounds.
• The employee must be able to move 55-gallon drums.
• The employee must be able to qualify for and use respiratory protective equipment.
• Specific vision abilities required by this job include close vision, distance vision, color vision, depth perception, and ability to adjust focus.

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