Prometic Plasma Resources (PPR) Inc’s key focus is in the collection of high-quality Source Plasma that is the vital ingredient in Prometic’s life-saving plasma protein drugs. With every donation collected at our centers, we are able to contribute to the creation of potentially life-saving products that would otherwise not be available.
Managed by a team of qualified and highly trained professionals who have decades of experience in the field of plasma collection, Prometic Plasma Resources strives to create an enjoyable donation experience for each and every donor.
Prometic has an opening for a Medical Laboratory Director at its plasma collection center, located in Amherst, New York. This is a part-time position, under supervision of the Manager, Plasma Center. The Medical Laboratory Director will provide medical oversight to ensure compliance, and serve as, or delegate to appropriately credentialed personnel, the duties of laboratory director, technical consultant, or clinical consultant.
The successful candidate will join a team that exemplifies and demonstrates our corporate culture of inclusion, mutual respect, hard work, and dedication with the core belief that together we succeed. If you would like to join a company that values its employees, products and customers, you are invited to submit your candidacy for the Medical Laboratory Director position.
The Medical Laboratory Director:
Provides medical oversight in compliance with applicable Federal and State regulations including the applicable sections of Title 21 of the Code of Federal Regulations. Monitors medical compliance of the center. May serve as the primary physician for reporting to the Food and Drug Administration and the New York State Department of Health.
Ensures compliance with the Clinical Laboratory Improvement Act of 1988 regulations (CLIA), the Director Sustaining Standard of Practice 3. Section 58-1.2 of 10 NYCRR. and other applicable New York State regulations.
Reviews, understands, and complies with all Prometic Plasma Resources policies. Maintains high medical and laboratory standards and ensures that cGMPs are adhered to through involvement with center management, center QA, and overall testing activities.
Is physically on-site for approximately 4 hours per week to effectively discharge the responsibilities of Medical/Laboratory Director.
Principal Laboratory Responsibilities:
Provides oversight of all aspects of the laboratory’s quality management system to ensure conformance to requirements.
Maintains the technical accuracy and medical reliability of tests performed at the Plasma Collection Center.
Ensures that the center is enrolled in CMS- approved proficiency testing programs for all testing performed and adheres to administrative and technical requirements for proficiency testing.
Ensures that policies and procedures are established for monitoring staff to assess competency, and whenever necessary, provide remedial training or continuing education to improve skills.
Assures that training, testing, proficiency and documentation comply with the applicable regulations.
Reviews quality control results monthly and proficiency records as needed to assure compliance.
Principal Medical Responsibilities:
Provides medical oversight to Physician Substitutes, including their training, although such training may be delegated to an approved Physician Substitute or area subject matter expert. Trains other physicians; evaluates newly trained Physician’s Substitutes for completion of training and recommendation for certification. Functionally directs the Center Medical Staff. Provides training to other center staff on medically related procedures and practices.
Reviews medical documentation weekly, including approximately 20% of medical exams performed by the Physician Substitutes and 100% of remote communications.
Meets with Physician Substitutes at least once a month to discuss medically related topics. Documents each meeting.
Provides guidance regarding donor suitability for plasmapheresis and/or approvals in person, telephonically or other means.
Reviews moderate and severe medical incident reports and evaluates the donor’s eligibility to resume donating.
Reviews test results including abnormal serum protein electrophoresis (SPE) test results and donor record files to determine a donor’s continued eligibility.
When applicable, oversees hyper-immune programs to assure the health and safety of participating donors.
For red cell immunization programs, performs the qualifying evaluation of participants (e.g. administers consents, medical history and physical exam); schedules immunizations and evaluates clinical response; is physically present when red cell immunizations are given.
May perform center physician functions including but not limited to notifying donors of unsuitable test results, performing medical evaluations, assessing results of donor screening and laboratory tests to determine a donor’s initial and continued suitability for plasmapheresis, explaining informed consent materials to donors, conduct confidential interviews with or provide counseling to donors, makes medical decisions about donor eligibility and unit suitability.
Performs additional services as and when requested by the company.
Prometic offers a competitive compensation package and is committed to employee development.
To apply, please send a cover letter and a copy of your resume to firstname.lastname@example.org with the following reference: PT - Medical Laboratory Director Amherst NY
Prometic is an equal opportunity employer. Accommodations are available on request throughout the recruitment cycle. Only chosen candidates will be contacted for an interview. For more information about Prometic, visit our website www.prometic.com
The minimum education required is an M.D., D.O., from an accredited institution.
Must maintain a current and active New York State license and Certificate of Qualification as a laboratory director in the category of Blood Bank – Comprehensive.
Knowledge of FDA, CLIA, OSHA, NYSDOH and IQPP regulations and standards applicable to the qualification, testing and donation process. Plasmapheresis experience is preferred.
Internal Number: PT
About Prometic Plasma Resources
Prometic is a biopharmaceutical corporation with two drug discovery platforms focusing on unmet medical needs in the field of fibrosis and orphan diseases. These include Small Molecule Therapeutics (PSMT) and Plasma-Derived Protein Therapeutics. Prometic Plasma Resources (PPR) supports the efforts of Prometic by supplying needed Plasma for the development of these life changing products. PPR is opening its first Plasma Center in the USA in Amherst, New York and is seeking a Medical Laboratory Director who is licensed in New York State and holds a Certificate of Qualification in Blood Bank- Comprehensive.