Supervisor, Manufacturing Downstream

• 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

• 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.  

• 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.