Environmental Control Supervisor

Location
Louisville, KY
Posted
Mar 27, 2021
Ref
1012
Required Education
Other
Position Type
Full time

Job Title: Environmental Control Supervisor

Schedule: Full-time (1st)

Location: Louisville, KY

Reports to: Associate Director, Manufacturing

Direct Reports: 1-2

Job Description

An Environmental Control Supervisor is a professional responsible for the Environmental Control Strategy related to clinical cell therapy manufacturing in a GMP and GTP compliant ISO 7 classified cleanroom facility. The primary responsibilities of this role are focused on the environmental monitoring control strategy in place to support the manufacturing of aseptically processed cell therapy products. Secondary responsibilities of this role will include providing technical leadership, daily oversight, and subject matter expertise in manufacturing and environmental control.

Principle Duties and Responsibilities:

 

  • Provides the microbiological expertise, leadership, and guidance to ensure operations and staff implement appropriate microbial controls to meet regulatory requirements.
  • Provides microbiological expertise to support product dispositions, investigations, risk analyses, and mitigations related to aseptic processing, and micro testing.
  • Leads collaboration to develop and implement improvement strategies related to Talaris Environmental Monitoring Program.
  • Train, supervise, and mentor GMP Environmental Monitoring personnel to develop a strong team of highly skilled professionals responsible for conducting Environmental Monitoring Sampling.
  • Leads collaboration between cross-functional departments to implement a new cleaning strategy that complies with industry guidelines.
  • Leads the implementation of new gowning strategy for personnel working in the ISO 7 cleanrooms.
  • Oversees Aseptic Process Simulation to ensure it meets the regulatory requirements.

 


Secondary Responsibilities:

 

 

 

  • Assist in evaluating new technologies, assays, and clinical research protocols.
  • Assist in conducting data analysis and preparing reports.
  • Responsible for maintaining training requirements up to date.
  • Perform related duties as assigned.

 


Minimum Education, Training, and Experience Requirements

 

 

 

  • A bachelor’s degree in the science field, preferably in Microbiology or Clinical Laboratory Science.
  • Minimum of five years’ experience in biopharmaceutical and/or clinical microbiology laboratories preferably in a commercial or FDA-approved products setting.

 

  • Demonstrate detailed understanding of applicable scientific principles and theories used in the quality control of environmental monitoring.
  • Demonstrate attention to detail. Knowledge of GMP, OSHA (including biosafety), and FDA regulations.
  • Demonstrate ability to manage multiple projects simultaneously.
  • Demonstrate strong team-building abilities.
  • Good aseptic technique and proficiency in handling microbial cultures.
  • Experienced or knowledgeable in working in a regulated cGMP environment.
  • Familiarity with Environmental Monitoring principles.
  • Excellent verbal and written communication skills.
  • Ability to perform data analysis, trending, and generate reports as required.
  • Ability to strive in a fast-paced, creative, and goal-oriented environment.
  • Plan, organize and execute protocols under minimal supervision following cGMP guidelines.
  • Maintain accurate and detailed documentation according to regulatory guidelines.
  • Periodically present results and summarize progress to team members.
  • Proficiency in computer systems and Microsoft Office suite.
  • Flexibility to assist in other tasks as required.

 


Additional Qualifications

 

 

  • Flexibility and dedication: Position will require “off-standard hours” and “on-call” hours as related to specific clinical trials, including some nighttime hours during manufacturing; may require overtime.
  • Please note that the position requires a general occupational health screening performed by an approved occupational health unit to work with the “open product” in the bone marrow processing cGMP facility. These examinations are necessary to protect the “open product” during bone marrow processing. Applicants who intend to work with open products shall not submit to a health screen until after an offer of employment has been made.

 


Physical Requirements:

 

 

 

  • Prolonged period of standing, sitting, and working on a computer.
  • Must be able to lift 50 pounds at times.
  • Must be able to access, navigate and work in a GMP laboratory environment.
  • Ability to work some irregular hours, including evenings or weekends, depending on workload.

 


Benefits:

 

 

 

  • Health insurance
  • Dental insurance
  • Vision insurance
  • Paid time off 25 days
  • Stock Options
  • 401k

 


Talaris Therapeutics, Inc. (“Talaris”) is a late-clinical stage biotechnology company that is developing transformative cell therapies with the potential to eliminate the burden of chronic immunosuppression for organ transplant recipients as well as induce durable remissions in patients with severe autoimmune and immune-mediated disorders. Achieving durable, drug-free immune tolerance to a donated organ has been referred to as a “Holy Grail” of organ transplant. In a ground-breaking, phase 2 study conducted between 2009 – 2016, our lead therapy, FCR001, enabled 70% of living donor kidney transplant recipients to be weaned off all immunosuppression within 12 months of their kidney transplant, without rejecting their donated organ. The benefits of our therapy have been shown to be extremely durable. We have followed these patients for an average of over five years since their transplant, and the longest for over ten years and not a single patient who was tolerized in our phase 2 study has subsequently had to resume immunosuppression. Since late-2018, Talaris has raised over $190M in private financing from leading life sciences investors and has initiated a Phase 3 registration trial of our therapy in living donor kidney transplant patients. In 2021, the company also plans to initiate Phase 2 trials of FCR001 in scleroderma as well as in patients who have previously received a living donor kidney transplant. Our cell processing facility is based in Louisville, KY, and we have a corporate office in Boston, MA.