Senior RN Manager, Site Operations

Req ID #:  222294
Location: 

Lowell, MA, US, 01854

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.

Job Summary

The Senior RN Manager, Site Operations at the Lowell site works under the supervision of the Executive Director, Donor Room Operations. This individual will manage daily operational activities and be an active member of the donor room using apheresis skills to help safely screen and collect consented donors, working within quality guidelines set forth by the Company and all applicable regulatory agencies to provide the highest quality products and services to internal and external stakeholders.  Assists in hiring, supervising, scheduling, and training staff for the Lowell site.  Will assist and be responsible for understanding budgetary and staffing guidelines to ensure company goals are met. 

 

Essential Responsibilities

•    Manages projects as needed and as assigned, assumes responsibility for management of technical or administrative projects critical to the success of the organization at the site. Takes a leadership role and obtains cooperation and support from applicable management and staff from different departments to accomplish completion of projects. Provides regular feedback to the Executive Director, Donor Room Operations on the status of projects.
•    Serves a Subject Matter Expert (SME) on leukapheresis for the site and takes lead role in SOP review and standardization with other nursing SMEs globally within Cell Solutions organization. 
•    Maintains accurate records, including clinical research records, blood product collection-associated forms, apheresis collection records, annual estimated blood loss and reaction/complication forms.
•    Works under medical supervision of the Medical Director of the site related to donor eligibility and donor qualification and donor safety during apheresis collection process.  Ability to follow Medical Director’s verbal or written instructions for optimal care of donor.
•    Financial responsibility (P&L) including oversight of the expenses and assist to drive revenue for the site to contribute to the overall P&L of the business unit.
•    Provides education and training to employees and others as needed.
•    Serve as interface between device manufacturers and internal operations as needed. Working with Cell Solutions’ Facilities team, ensure that Preventative Maintenance (PM) work is scheduled by the device manufacturer’s field service engineers as required and proper sticker/labeling of completion of PM work is applied to appropriate devices. 
•    Involved in review of SOPs/Change Controls for the site in conjunction with department leaders to make sure that they meet internal objectives and accurately describe the process and meet client requirements as applicable.  
•    Assists in developing, implementing, and monitoring department goals and objectives in a manner consistent with cost effectiveness and outstanding customer service.
•    Work with other Cell Solutions SMEs to develop, revise, and review SOPs (Standard Operating Procedures) to meet State, Federal, and AABB guidelines as well as the Company’s quality program plan.
•    Knows and follows safety rules relative to area(s) or responsibility.  Follows Standard Operating Procedures (SOPs) and Current Good Manufacturing Practices (cGMPs) and external regulations regarding the products and procedures.

Job Qualifications


•    Required Bachelor’s degree in Nursing. Preferred Master’s Degree in Nursing.
•    Minimum five years of nursing supervisor level experience, experience in apheresis preferred.  
•    Preferred RN with experience leading an apheresis operation or blood donor center
•    Prior experience in research environment a plus.
•    Experience with current Good Laboratory Practices, and/or current Good Clinical Practices and/or current Good Manufacturing Practices a plus. 

Compensation Data

The pay range for this position is $161,000 - $178,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

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 20,000 employees within 110 facilities in over 20 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 - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, or national origin, veteran or disability status.

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 [email protected]. 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. 
 


Nearest Major Market: Lowell
Nearest Secondary Market: Boston

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