DescriptionYour Role:The
Sr. Supervisor, Manufacturing Formulation is responsible for the supervision of manufacturing staff and operations as well as regularly performing hands on operational activities. This includes ensuring that production is maintained in full cGMP compliance through on the floor observation, direction, and participation.
Key Responsibilities:
- Schedule, plan and coordinate production activities.
- Operate and maintain Manufacturing production support equipment including but not limited to autoclave, depyrogenation oven, Cozzolli vial/bottle washer, Sartocheck filter integrity testers, pH/conductivity meters, Laminar Flow Hoods and Biosafety Cabinets.
- Support cell culture and bioreactor operations from thaw through TFF on the production floor, as required.
- cGMP documentation.
- Revise initiate and review Batch Production Records (BPRs), Standard Operating Procedures (SOPs), forms and Batch History Records (BHRs).
- Identify, escalate, and write deviation reports (IRs/DRs/CAPAs). Follow through on corrective and preventative actions to ensure cGMP compliance.
- Manage the development of SOPs to ensure all manufacturing operations comply with internal and external regulatory agencies.
- Coordinate manufacturing, validation, and maintenance activities with supporting departments.
- Oversee the setup of new manufacturing processes and critical equipment.
- Performing daily monitoring of equipment and equipment cleaning - manual cleaning.
- Identify the technical, procedural and equipment issues that hinder production and compliance.
- Communicate with team members, supervisor and members of other departments, as appropriate, to assure prompt resolution of problems.
- Assist in the transfer of technology from Process Development to GMP Manufacturing.
- Assist with technical and compliance investigations, inspections and audits.
- Report all unsafe activities to department manager, EHS and/or Human Resources.
- Participate in proactive team efforts to achieve departmental and company goals.
- Manage direct reports and escalate issues to manager as needed.
- Directs activities of functional areas through associate level employees.
- Perform other duties as assigned.
Minimum Qualifications:- Related Bachelor's degree (i.e. Biology, Biotechnology, Chemical Engineering) plus 3 - 5 years cGMP support and formulation experience plus 1 - 3 years leadership experience or equivalent combination of experience.
Position Type/Expected Hours of Work:This role is a full-time onsite position. Days and hours of work are Wednesday through Saturday, 4 day x 10 hours unless otherwise stated by Supervisor. The employee must also have the ability to work overtime and/or weekends when necessary.
Compensation: We offer competitive compensation packages for this role, including a base salary, performance-based bonuses, and comprehensive benefits such as health, dental, and vision insurance, 401(k) matching, and paid time off.
The compensation range for this role is TBD annually depending on experience and qualifications. Additionally, we offer opportunities for career growth and development as well as a supportive and inclusive work environment.
Who you are: - You have a "bring it on!" team player approach and an unshakable positive attitude, always ready to tackle anything that comes your way.
- Your written and verbal skills are out of this world, and you communicate with clarity and confidence.
- You have exceptional multitasking skills and an unparalleled attention to detail that ensure the smooth running of everything.
- You are a master at building relationships, capable of establishing connections with anyone, be it team members, clients, vendors, or suppliers.
Physical Demands & Work Environment: In this dynamic role, expect a blend of regular activities like sitting, standing, and walking, with occasional physically engaging tasks such as lifting objects up to 25 pounds. The work environment might expose you to electrical shocks, toxic chemicals, vibrations, or loud noise levels occasionally. However, reasonable accommodations are available to enable individuals with different abilities to perform effectively, ensuring a supportive and adaptable work setting. Your visual acuity, including close, distance, and color vision, will be essential in navigating through the diverse day-to-day demands of this position.
