Manufacturing Supervisor, Downstream

Job Description

BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Manufacturing Supervisor, Downstream to work for an Orange County area biopharmaceutical company.

Salary: $90-120k depending on experience

Summary:

The Downstream Manufacturing Supervisor 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.

Responsibilities:

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.

Qualifications:

Bachelor’s degree in biology, biochemistry, or related life sciences field with 3+ years of industry experience

CHO Cell Manufacturing experience in a GMP Biologics environment

3+ years of Purification (column chromatography, nano-filtration, tangential flow filtration, aseptic bulk fills, etc.)

3+ years of experience writing BPRs and Deviation reports

Ability to work overtime and weekends as required

Ability to work 4/10 schedule

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