DescriptionYour Role:The
Supervisor, Manufacturing Downstream is responsible for the supervision of Downstream 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.
- Schedule, plan and coordinate production activities.
- Perform purification operations (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.) 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.
- 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.
- Perform other duties as assigned
Minimum Qualifications:- Bachelor's degree in biology, Biotechnology, Chemical Engineering or related field plus 3 - 5 years' cGMP purification experience or equivalent combination of experience and education.
- A minimum of 3 years of supervisory experience specifically in downstream processing is required. The ideal candidate will be a self-driven leader with a proven track record of building strong and efficient floor operations.
Preferred Qualifications:- Bachelor's degree in life sciences or related field.
Position Type/Expected Hours of Work:This role is a full-time position with a Sunday through Wednesday or a Wednesday through Saturday schedule, working 10 hours each day (4 days x 10 hours), with operating hours from 5:00pm to 4:00am. During the initial training period, working days and hours will be Monday through Friday 7:00am to 4:00pm.
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 $75,000 - $95,000 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 20 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.
