Bioprocessing Supervisor

Overview

Cook MyoSite, Inc. is on a mission to make regenerative medicine a part of everyday medicine. We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders. We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours. Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose. If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.

The Bioprocessing Supervisor at Cook MyoSite, Inc. provides oversight and schedule daily activities associated with manufacturing cellular products which meet company Quality System standards, standard operating procedures, and regulatory requirements.

Responsibilities

• Provide direct guidance to employees to ensure products and operations meet the company Quality System, cGMPs, and safety standards• Schedule resources to ensure that all daily tasks are completed, filling in manufacturing responsibility gaps as necessary• Delegate work to employees, track progress and provide constructive feedback throughout projects and tasks• Organize workflow and ensure that employees understand their duties or delegated tasks• Act as functional point person for troubleshooting, coordination with other functional groups, and providing decision points for product and operational concerns• Able to obtain and maintain required internal company qualifications, including but not limited to: gowning qualification, aseptic qualification• Follow proper cleanroom behavior and aseptic practices while working inside the manufacturing suite and cleanroom environments• Initiate, author, and perform departmental review of quality system records and documentation (i.e. investigations, batch records)• Document and review required information in Production batch records and associated forms in a timely fashion• Assist department in improving/optimizing manufacturing processes• Assist with addressing problems with work quality, issues between employees and other concerns in an effective, timely manner• Perform preparation of media, bulk solutions, filling and labeling of vials under sterile conditions• Perform dissociation of human tissue to establish cell cultures• Perform routine cell culture maintenance (media changes and passages)• Perform terminal cell culture harvesting, formulation, and filling for releasable products• Collect and submit product generated and environmental monitoring samples• Perform established cell count and viability assays using a flow cytometer• Perform routine daily culture monitoring of products; both manually, and using an automated system• Quarantine and store manufactured products• Assist with routine sanitizations of laboratories and the manufacturing suite with required use of half-faced respirator and/or PAPR along with additional PPE• Assist with routine sanitizations of manufacturing laboratory equipment in accordance with set procedures• Assist with inventory management, and ordering, to maintain an adequate supply of resources for manufacturing of products• Assist with performing established processing area preparation and change over procedures for product interventions, routine sanitization of BSHs, and product lot clearance

Qualifications

• Undergraduate degree in any Life Sciences or Engineering field or 6 years direct, relevant experience in a laboratory / manufacturing environment to provide a comparable background

• Minimum of 6 years' experience in a biologics /medical device / biopharmaceutical manufacturing environment is preferred

• Knowledge and application of industry standards and guidelines/regulations related to the manufacturing of sterile injectable drug and biologic products (21 CFR 210 and 211) and cGMPs

• Advanced proficiency in MS Office, specifically, advanced knowledge of Project, Adobe, OneNote, Excel, Word and PowerPoint; Expert in Outlook• Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing

• Demonstrates strong interpersonal skills resulting in exceptional rapport with people. Proven success initiating, promoting and maintaining strong interpersonal relations• Is a teacher and trusted leader.• Identifies and effectively manages conflict.

Physical Requirements:

• Laboratory Setting (Production): General office, warehouse and laboratory setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II.

• Ability to conduct and hear ordinary conversation and telephone communication.• Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.• Ability to work under specific time constraints.• Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time on a regular basis and periodically for up to 3 hours at time.• A minimum of 20/20 vision with or without correction with both eyes on the Pocket Vision Screener from 14 inches. A minimum of 20/20 vision with or without correction in both eyes on Graham Field Eye test chart from 10 feet. Must be able to identify colors on the Ishihara Charts of Color Deficiency.• Ability to spend majority of day standing in laboratory setting or sitting in biological safety hood setting with potential (limited) exposure to hazardous chemicals and/or harsh disinfectants while in BioSafety Level II or other labs.• Must be able to maintain manual acuity for working with computers and equipment. Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.• Physically capable of standing, walking, stooping, kneeling, crouching, climbing steps and ladders, reaching, twisting and bending on occasion with or without reasonable accommodations.• Must be able to lift/push/pull up to 50 pounds on an occasional basis with or without reasonable accommodations.• Must be capable of performing PPE gowning procedures on a frequent basis to enter BioSafety Level II including safety glasses, lab coat, gloves, specialized clothing including laboratory scrubs (pants and shirt) hood, facial mask and appropriate shoes required on a regular basis.• Must be capable of performing PPE gowning procedures, aseptically for up to 5.5 hours at a minimum of one time per year.• Must be able to extend arms outright for extended periods of time, periodically at intervals for up to 3 hours at a time.• Must be able to maintain focus, aseptic qualifications and performance standards of position for extended periods of time without rest periods; periodically at intervals for up to 5.5 hours at a time