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Supervisor, CGMP Biomanufacturing Upstream

Madison, WI

Posted: 02/16/2021 Industry: R&D Scientist Job Number: JN -022021-12536

Job Description

Supervisor, CGMP Biomanufacturing Upstream

(This is NOT an HR position. This position provides guidance and ensures compliance in GMP training practices, documentation and Environmental Health and Safety)

SRG offers flexible staffing solutions with a national presence. We provide contract, contract-to-hire, direct hire, and executive search services. SRG utilizes an innovative approach to identify and qualify talent that is unique to the Staffing industry, featuring a cutting-edge platform that allows us to match professionals rapidly and precisely to client requirements. We have a proprietary database of over one million candidates and maintain continuous contact with our qualified talent.
  • Title: Supervisor, CGMP Biomanufacturing Upstream
  • Location: Madison, WI
  • Industry: Pharmaceutical
  • Hours: SHIFIT Sun-Wed, 6am-4pm
  • Salary: $33.65hr (Paid Weekly - Benefits Available)
  • Employment Type: Long Term Contract
Environment: This client manufactures thousands of pharmaceutical, biologic, consumer health and beauty products utilizing superior and innovative drug delivery technologies to improve their value to patients and consumers. Our customer believes in a Patient First culture putting patients at the center of their work to ensure the safety, reliable supply, and optimal performance of our products.

Job Summary:
The Supervisor spends most of the time assigning, reviewing, checking work, assisting in the manufacturing suites, and eliminating ordinary difficulties. This person also recommends candidates for hiring, termination, prepares and conducts performance reviews and salary reviews, and applies company policies. The position is expected to follow detailed instructions and established procedures with minimal supervision.

Job Scope:
This is a Supervisor role for the biomanufacturing department. This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufacturing operations, while adhering to SOPs and working in a cGMP compliant environment. Analyze and interpret results in written and oral format. Other duties will include Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of (including contributions to performance management) staff and driving process improvement initiatives. The role will also ensure that staff continues to be developed to keep pace with department goals and growth. This is a Supervisor role for the biomanufacturing department. This position requires a variety of skills necessary for a cGMP Biomanufacturing environment. Independently perform Biomanufacturing operations, while adhering to SOPs and working in a cGMP compliant environment. Analyze and interpret results in written and oral format. Other duties will include Batch Production Record/data review, drafting technical documents protocols and reports, training/mentorship of (including contributions to performance management) staff and driving process improvement initiatives. The role will also ensure that staff continues to be developed to keep pace with department goals and growth. This position generally supervises one to ten direct reports. The Supervisor spends the majority of the time assigning, reviewing, checking work, assisting in the manufacturing suites and eliminating ordinary difficulties. This person also recommends candidates for hiring, termination, prepares and conducts performance reviews and salary reviews, and applies company policies. The position is expected to follow detailed instructions and established procedures with minimal supervision. Supervise cGMP

Specific Duties, Activities, and Responsibilities:
Author and revise Standard Operating Procedures (SOP), Batch Production Records (BPR) and Job Aid (JA)
Maintain effectiveness of Quality system
Supervise general cleanroom housekeeping, including room and equipment cleaning(s), disposal of trash and recyclables, and adherence to 5S standards
Train, monitor and mentor direct reports on Biomanufacturing activities
Act as Subject Matter Expert (SME) on Biomanufacturing activities
Supervise continuous process improvement initiatives
Coordinate with Manager/Director to prioritize and schedule activities to meet deadlines
Supervise, execute and document cGMP Biomanufacturing activities
Supervise operation of cGMP Biomanufacturing equipment such as pH/conductivity meters, mixing tanks (SUMs), tubing fusers/sealers, filter integrity testers, peristaltic pumps, balances and BioSafety Cabinets (BSC) or Laminar Flow Hoods (LFH)
Supervise/Stage raw materials/components for use within cGMP Biomanufacturing
Supervise completion of routine and preventive maintenance on Biomanufacturing equipment
Supervise/lead deviation investigations and change control/protocol execution in a time sensitive fashion
Supervise/execute equipment qualification/validation protocols, as required
Supervise Media/Solution Preparation, as required
Ability to work scheduled shift and other off-shift coverage as required
Upstream Mfg responsibilities include:


Education Requirements:
PhD in Biotechnology, or related field, with minimum of 2 years experience in related work or related experience with demonstrated career progression including leadership responsibilities
M.S./M.A. in Biotechnology, or related field, with minimum of 3 years experience in related work or related experience with demonstrated career progression including leadership responsibilities
B.S./B.A. in Biotechnology, or related field, with minimum of 6 years experience in related work or related experience with demonstrated career progression including leadership responsibilities
Associates Degree, minimum of 8 years experience in in related laboratory work or related experience with demonstrated career progression including leadership responsibilities

Experience Required:
Clean room, aseptic technique, and general lab equipment experience
cGMP, Good documentation practices (GDP), Good Laboratory Practices (GLP) knowledge
Following standard operating procedures
Experience operating, maintaining and troubleshooting Biomanufacturing-related equipment

Technical Requirements:
Ability to transfer knowledge to others via training or mentoring of staff; demonstrated ability to guide others through communication and learning.
Ability to understand opposing points of view on highly complex issues and to negotiate and integrate different viewpoints.
Ability to make decisions which have significant impact on the department s credibility, operations, and services.

EOE/ADA




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