High Potency API Lead

Job Description

The High Potency API Lead will be responsible for the manufacturing of highly potent API pharmaceuticals in kilogram-scale lab (Glass equipment ranging from 5L-100L) in accordance with customer and internal specifications.

Key Responsibilities / Accountabilities

• Assistance in the execution of Quality and Safety inspections, trainings, and programs for the Production group. Works collaboratively with SMEs in Safety, Quality, Maintenance, Training, etc. to translate objectives to Production.

• Completes batch records in accordance with FDA and Current Good Manufacturing Practices (cGMP) guidelines

• Provide process support and troubleshooting necessary to meet all customer requirements

• Maintain the facility in excellent FDA/cGMP posture

• Responsible for safety equipment and active participation in safety program and hazard analysis. Wears appropriate PPE for task.

• Ensures that waste is appropriately characterized, labelled, stored and disposed in compliance with all Company, state and federal regulations. Works collaboratively with Environmental, Health & Safety, as appropriate.

• Assures all production/support equipment is in proper operating condition and that all production equipment is appropriately labelled with a current status tag. Works collaboratively with Maintenance, as appropriate.

• Ensures the security and safe handling of all controlled substances at all times. Strictly adheres to all Company and DEA regulations.

• Active member of Emergency Response Team. Participate in Emergency Response Training and related activities.

• Promotes a positive work environment by maintaining a safe work area and ensuring that their team members have the knowledge, skills and appropriate tools to perform their assigned duties and a thorough understanding of their performance expectations.

• Demonstrates a professional and positive attitude, integrity and a strong work ethic and encourages team members to do the same.

• Cooperate with all root cause investigations and follow corrective actions and compliance with Company policies and procedures, and all state and federal regulations occurs within department.

• Operates machines and equipment that involves set up and making adjustments to regulate temperature, pressure, flow and reactions or materials safely and in accordance with batch record and work instructions.

• Able to complete basic mechanical work required to keep operation moving

• Resolve regular technical problems and takes action to ensure the production plan continues to move

Qualifications

• High School Diploma with 5-10 years of experience in highly potent API Manufacturing OR

• AA in Chemistry, Engineering, or other related technical field with 3-5 years of experience OR

• BS in Chemistry, Engineering or other related technical field with 1-2 years of experience

• Solid understanding of GMP and FDA

• Safety awareness & effective communication

• Ability to independently apply scientific and/or technical knowledge in the performance of job duties

Special Factors

• Walking, standing for long periods of time while in plant, reaching, handling, twisting, and bending spine at waist when operating equipment.

• Obtain and maintain certification as forklift operator

• Able to lift 50lbs

• Must be willing to work a rotating shift