Cleanroom Manager

Req ID #:  102364
Location: 

Northridge, CA, US, 91325


For over 40 years, HemaCare, a Charles River company, has worked to making a positive impact on the world by providing the highest quality cellular material and services to biotech and
pharmaceutical companies and research organizations that are performing innovative research and developing novel cell-based therapies.

 

We recognize that our success depends on the vision and passion of our employees; that is why we are devoted to making HemaCare a rewarding and valuable place to work. We believe in making a difference, and at HemaCare, you will make a difference every day.

 

IMPORTANT:   In order to be considered for this position, a resume/CV must be uploaded and submitted during the application process.  Please make sure work history and education are added correctly.   

Job Summary

The Manager, GMP Cleanroom will supervise the day-to-day activities within the department, which include, but are not limited to, coordinating the manufacturing of products within the cleanroom, and overseeing the maintenance of the environment.  Additional duties include training personnel, generating or revising SOPs, maintaining process batch records, and scheduling miscellaneous tasks.  This position reports to the Director, GMP Cleanroom.  

 

Essential Responsibilities:
•    Acts as organizer and point of contact regarding all staff.  Coordinates and monitors work activities as well as establishing workflow management for manufacturing optimization.  Oversees and distributes workloads amongst staff.  Identifies and troubleshoots problems encountered in assigned tasks and properly document corrective actions.  Maintains a strong floor presence and enforces cGMP, SOPs, and other company policies.
•    Trains incoming personnel as needed on SOP’s, Batch Records, and other process and department related procedures and activities.  Assists in organizing training of department personnel as required and report all discrepancies to management immediately.
•    Follows all safety procedures within cGMP manufacturing areas, ensures employees practice proper safety procedures, and communicates any safety equipment that is not functional to appropriate authorities for correction.
•    Directly responsible for the appearance and neatness of manufacturing environment within department in accordance with cGMP, SOPs, and other company policies.  Plans and coordinates the cleaning/disinfection of the space as well as continually monitoring the cleanroom cleaning to ensure all activities are completed promptly and correctly.
•    Coordinates routine and non-routine maintenance within the master production schedule; work closely with facility personnel to obtain information needed to assess equipment problems.  Coordinates the ordering of cleanroom equipment.
•    Responsible for inventory and ancillary supply restocking, expiration date checking, and tracks and maintains raw materials, gowning supplies, and other inventory for the maintenance of the cleanroom and other supportive areas.
•    Must maintain knowledge of and follow applicable Standard Operating Procedures for accuracy, safety, and cleanliness.  Complies with all state and federal laws, rules, and regulations governing the practice of manufacturing and blood banking, including HIPAA.
•    Maintains records in compliance with manufacturing and regulatory guidelines.  Ability to review and complete all the documents/results needed for all the GMP product batch records.  Reviews data for deficiencies.  Resolves discrepancies by using standard procedures or returning incomplete documents for resolution.
•    Detects problems and reports information to appropriate personnel.  Ability to identify and aid in the investigation of deviations.  Reports errors and be able to initiate and write deviations.

Job Qualifications

•    Must possess 2 or more years of working within a cleanroom environment.
•    A four-year degree in a biological science or equivalent discipline or a comparable combination of experience and education is required.
•    Experience in aseptic processing is required.
•    Experience with cellular clinical product is preferred.
•    Detailed work ethic, accountable, and disciplined in actions.
•    Willingness to take ownership and complete tasks on time.
•    Proficient use of Microsoft Office products including Word, Excel, Outlook, and PowerPoint.

 

 

IMPORTANT: A resume is required to be considered for this position. If you have not uploaded your resume in your candidate profile, please return to upload field and attach your resume/CV. 
 

About HemaCare 

HemaCare, a Charles River company, is a global leader and trusted brand in the customization of human-derived biological products and services for biomedical research, drug discovery, and cell and gene therapy development. HemaCare’s vertically integrated solutions support preclinical research, clinical studies from phases 1 to 3, and commercialization with high-quality RUO and GMP-compliant starting material and apheresis collections. 

 

In January 2020, HemaCare was acquired by Charles River Laboratories, an early-stage contract research organization (CRO). Combined with Charles River’s integrated, early-stage portfolio of discovery, safety assessment, and manufacturing support services, the acquisition creates a unique, comprehensive solution for researchers and cell therapy developers and manufacturers worldwide to help accelerate their critical programs from basic research and proof-of-concept to regulatory approval and commercialization. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs and enhances their productivity and effectiveness to increase speed to market. We work closely with our clients throughout the clinical process to maximize success and drive positive clinical outcomes. 

 

Together, with over 17,000 employees within 80 facilities in 23 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical and biotechnology companies, government agencies, and hospitals and academic institutions around the world. 

 

At HemaCare, we are passionate about our role in improving the quality of people’s lives. We have proudly supported the development of 100% of the current commercially available FDA-approved immunocellular therapies. Our mission is to provide a best-in-class portfolio of high quality, customizable human cellular material and services to support drug discovery, scientific research, and cell therapy. This resonates from our employees and impacts our customers because we know that every day is an opportunity to advance discoveries and make a difference in someone’s life. 

 

Equal Employment Opportunity
Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

 

For more information, please visit www.criver.com and  www.hemacare.com. 
 
 


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