Shifts: M-F, 1st (7AM to 4PM) and 2nd (3PM to 12AM) Available
Pay: $100K - $125K annually, based on experience
Qualifications:
Thorough understanding of cGMP, FDA guidelines, and multinational regulatory standards.
At least 2 years of prior management/leadership experience.
Minimum of 4 years Aseptic Production experience.
Prior experience with regulatory authorities preferred.
Bachelor's degree in Life Sciences or related field, or equivalent work experience.
Responsibilities:
Provide leadership to Aseptic Manufacturing Associates of various levels, including hiring, managing, motivating, coaching, and mentoring.
Ensure oversight of Aseptic Manufacturing operations across shifts, including weekend support as needed.
Complete internal batch record review and assist with authoring and implementing manufacturing procedures and batch records.
Lead routine manufacturing activities, including day-to-day scheduling and management of raw materials/consumables.
Perform component and equipment preparation, bulk drug formulation, and aseptic filling duties while accurately documenting data and completing batch records.
Successfully complete facility's gowning and media fill qualification program.
Train other employees in various manufacturing tasks, including Component Preparation, Formulation Operations, Lyophilization Processes, Product Accountability, and Sterile Filling.
Operate and assist with the maintenance of production equipment, performing duties in cleanroom areas and helping to maintain cleanliness.
Ensure personnel on shift are trained on all applicable procedures and master batch records prior to execution.
Initiate revisions to cGMP procedures and master batch records, and assist in scheduling and performing routine maintenance and calibration of production equipment.
Participate in client communications, problem-solving, schedule development, and project status updates.
Interface with auditors, including client representatives and regulatory agencies.
Perform Manufacturing review and approval of cGMP documentation in support of continuous improvements.
Support Agency, customer, and vendor audits as needed while exhibiting professional behavior.
Perform all other tasks, projects, and duties as assigned.