Vitalant Research Institute (VRI) (www.bsrisf.org), internationally respected for its work to advance blood safety worldwide has established a campus in Denver, Colorado on the grounds of the Vitalant Blood Center, formerly known as Bonfils, to focus on the development of blood products and transfusion methodologies. We are building a team to conduct the research and cGMP manufacturing of cryopreserved platelets to support ongoing clinical trials in the USA sponsored by the US Army. The program is expanding to broaden research and development activities for platelets and red blood cells for transfusion.
VRI Denver is now hiring a Clinical Laboratory Manager to work in a team to set-up, staff and validate cGMP blood product manufacturing and testing operations. This is a research and development position. This position will initially focus on the manufacturing, storage, testing and distribution of investigational frozen platelet products being developed and clinically validated under the sponsorship of the US Army.
The project is moving into Phase 2 and is on a strong development and regulatory track for FDA approval.
Under limited direction, this position is responsible for managing the overall activities, supervision of technical staff, scheduling technical staff and project flow, and providing skilled technical oversight in the laboratory. Works with other team members to ensure timely and high quality results. This is a research and development position Monday-Friday, day shift.
Duties and Responsibilities Include:
Performs all assigned duties in compliance with internal SOPs and external regulations. Brings compliance issues to the attention of management.
Assures quality customer service to all customers.
Hires, supervises, trains, and evaluates performance of assigned personnel. Identifies and effectively resolves personnel issues.
Oversees all testing procedures (including quality control testing) to ensure compliance with practices, regulations, and/or any agreements/contracts.
Schedules all project workflow
Reviews and updates policies, protocols, and procedure manuals to ensure compliance with policies and accrediting agencies.
Maintains statistical information and reports of test data and quality control. Prepares activity reports and interprets, prepares and distributes statistical data regarding the laboratory. Ensures corrective action is implemented and brings issues to the attention of management.
Identifies and resolves problems related to equipment, computer software and hardware, test systems, reagent and technical issues within area(s) of responsibility. Ensures appropriate preventive maintenance and repair is performed on all technical equipment.
Manages the ongoing technical and professional development of staff.
Assists with management of the design, evaluation, implementation, and ongoing improvement of new testing methods, clinical evaluations and research projects, to increase efficiency.
Is responsible for oversight of supply and reagent inventory.
Leads or participates on process improvement teams.
Assists with developing and monitoring assigned budget.
Performs all other duties, at the discretion of management, as assigned.
Our organization is an equal employment/affirmative action employer. If you need accommodation for any part of the employment process because of a medical condition or disability, please send an e-mail to firstname.lastname@example.org or call 1-844-220-2612 to let us know the nature of your request. A representative will respond to accommodation requests within two business days. Please note that this email/phone number is for medical/disability accommodations only and any other inquiries will not receive a response.
To express your interest please submit your CV and cover letter by April 5, 2019 using the following link:
Bachelor’s degree in a chemical, physical, biological, medical technology or clinical laboratory science required.
Certification as a Medical Technologist by a recognized certifying agency required or CLIA equivalent for high complexity testing required.
BB or SBB preferred.
Seven (7) years of laboratory experience required.
Three (3) years of supervisory experience required.
Experience in cGMP manufacturing of blood products, blood banking, platelet testing, coagulation testing, and hematology laboratory methods and flow cytometry is preferred.
Experience in cGMP manufacturing of cell therapy or biologic products is preferred
Experience with specialty coagulation assays, specialty platelet function assays and flow cytometry is desirable.
Ability to promote a team work environment and participate as an active team member.
Excellent communication, interpersonal, and organizational skills.
Good supervisory skills with the ability to effectively utilize and develop personnel to execute job tasks.
Must be able to make sound decisions and work well under pressure.
Ability to analyze situations and take appropriate action which may be under strict deadlines. Capable of handling responsibility for timely volume of component production.
Ability to conceptualize computer software applications and computer equipment automation.
Ability to comprehend and apply clinical laboratory procedures and theory.
Proficient computer skills with the ability to retrieve data.
About Vitalant Research Institute
Vitalant Research Institute (VRI) is dedicated to advancing transfusion quality worldwide through scientific research, education and the promotion of evidence-based policies.
In the 50 years since our inception, BSRI has grown from a handful of researchers in the basement of Irwin Memorial Blood Bank to a distinguished institute engaged in research ranging from blood donor epidemiology to cellular therapy to virus discovery.
Following the tradition of our founder, Herbert Perkins, M.D., BSRI continues under the leadership of Director, Michael P. Busch, MD, PhD, to support the education and training of the next generation of researchers through fellowships, internships, mentoring and classes conducted in San Francisco and around the world.
Though the times have changed, our mission remains the same – an adequate and safe blood supply for all.