Lead Formulation Technician (12hr days, 2-2-3 rotation)

About the role

The Lead Formulation Technician will be responsible to produce sterile injectables and work on problems of moderate scope where analysis of situations or data requires a review of a variety of factors. This colleague follows written and verbal instructions when performing the following duties. Shift hours are 6am-6pm on a 2-2-3 rotating schedule.

Responsibilities

• Lead and oversee the preparation of complex formulations as well as automated filling and prep equipment ensuring adherence to precise specifications and quality standards.
• Mentor and train team members on advanced formulation, automated filling and prep equipment set-up and operation procedures, and troubleshooting methods.
• Collaborate with cross-functional teams to optimize production processes (SOP's, OJT's, and FWO) and implement continuous improvement initiatives.
• Ensure pharmaceutical products are manufactured in accordance with area SOPs and current cGMP.
• Verify and document production activities in batch records, logbooks and controlled forms.
• Complete tasks vital to manufacture drug products in an aseptic filling area, including:
  • Cleaning cGMP Areas
  • Perform line changeovers
  • Parts Preparation
  • Filter Integrity Testing
  • Operating Parts Washers and Autoclaves
  • Performing Tray Loading and Unloading
  • Operating the Filling Isolator
  • General Material Handling
  • Troubleshooting Equipment Alarms

Qualifications

• High School Diploma or equivalent required.
• Associate's with 1 year manufacturing experience preferred.
• Bachelor's preferred with no manufacturing experience.
• Minimum of three (3) years of experience in pharmaceutical, biopharmaceutical, or sterile manufacturing, four (4) years preferred.
• Equivalent combinations of education, training, and relevant work experience may be considered.
• Hands-on experience in aseptic or sterile product formulation and using SAP or other manufacturing systems strongly preferred.

Skills

• Strong technical expertise in formulation processes and quality control
• Strong technical expertise in sterile filling and filling prep processes and quality control
• Excellent problem-solving and decision-making skills
• Demonstrated ability to lead and mentor team members
• Effective communication and interpersonal skills
• Ability to drive continuous improvement and innovation in processes
• Strong organizational and time management skills

Physical Requirements & Work Environment

• Ability to stand for extended periods (up to 12 hours per shift) and walk frequently throughout the production area
• Capable of lifting and carrying up to 25 pounds occasionally and up to 10 pounds frequently
• Manual dexterity to operate various manufacturing equipment and instruments with precision
• Visual acuity to read detailed instructions, computer screens, and equipment displays
• Ability to wear personal protective equipment (PPE) for extended periods, including cleanroom suits, gloves, masks, Grade C gowning, and safety glasses
• Work is performed in a controlled cleanroom environment with exposure to pharmaceutical ingredients and chemicals
• Must be comfortable working in an environment with strict adherence to safety protocols and contamination control procedures
• May be required to work in areas with loud equipment or machinery
• Ability to work flexible hours, including potential mandatory overtime, weekend, or holiday shifts as needed to meet production demands
• Cleanroom restrictions: no hair products, jewelry, makeup, nail polish, perfume, exposed piercings, facial hair, etc. allowed