Production Manager, Medical Isotope Research and Production (MIRP)Job ID 2262 Date posted 10/19/2020
The mission of the Collider-Accelerator Department (C-AD) is to operate, maintain, improve, and upgrade the suite of electron, proton, and heavy ion accelerators used to carry out a program of accelerator-based experiments at Brookhaven National Laboratory (BNL). To support this program, the C-AD must design, fabricate, assemble, test, install, and operate unique research equipment to generate, transport, transfer, accelerate, focus, track, collide, and absorb high intensity particle beams up to energies of 250 GeV. This includes a combination of custom designed and built parts and vendor produced components developed by a collaboration of the C-AD scientific, engineering, and technical staff. The C-AD supports an international user community of over 1,500 scientists. The C-AD performs all these functions in an environmentally responsible and safe manner, under a rigorous conduct of operations approach.
The Collider-Accelerator Department has a position in the Medical Isotope Research and Production (MIRP) Program, for a Production Manager reporting directly to the Program Director, Dr. Cathy Cutler. This is a career-level scientific support researcher. The Production Manager will oversee the operation of laboratory and isotope production activities that occur in protective hot cells, to prepare radioisotopes and other radioactive materials for use as tracers for biological, biomedical, physiological, and industrial purposes, according to written procedures. In addition, the production manager will prepare production schedules to meet anticipated demand, and procedures and batch records that outline all production steps involved in the irradiation of targets, subsequent processing to and the shipping of the isotope products to the customer.
Essential Duties and Responsibilities:
- Supervise and oversee production operators. Oversees the operation of laboratory compounding equipment enclosed in protective hot cell to prepare radioisotopes and other radioactive materials for use as tracers for biological, biomedical, physiological, and industrial purposes including:
- Placing specified amounts of chemicals into container to be irradiated at accelerator or cyclotron facility.
- Coordinating production of isotopes requested by the National Isotope Development Center (NIDC) and associated activities with scientists and operators.
- Coordinating technology development for processing with the group.
- Controlling manipulators to pour liquids required to perform standard chemical analyses involving titration and filtration.
- Withdrawing radioactive sample for transport to chemical laboratory for analysis.
- Filling shipping container inside cell with prescribed quantity of radioisotope material for shipment pending sample approval.
- Plan, organize, schedule and assign work to subordinates.
- Monitor all production work to ensure compliance with existing DOE and FDA guidelines.
- Work with quality assurance personnel to ensure program is in compliance with all current good manufacturing process requirements and develop specifications for radionuclides supplied to external customers.
- Coordinate bringing up new production lines.
- Works with the Program Director to develop cost studies and budgets.
- Prepares production schedules to meet anticipated demand. Prepares plans that outline all production steps involved in the irradiation of targets, subsequent processing to and the shipping of the isotope products to the customer.
- Writes, reviews and approves all procedures related to the production of medical isotopes. Collaborates with Quality Assurance, Safety, and other disciplines to develop improvements to enhance the efficiency and effectiveness of production procedures.
- Writes, reviews and approves production batch records to ensure compliance with all production standards and guidelines.
- Attends and participates in planning meetings called to determine how procurements will be handled, end-user requirements, blanket purchase orders, and related issues.
- Performs production operator duties and other duties as required.
Minimum Required Knowledge, Skills, and Abilities:
- Bachelor’s degree in Chemistry, Physics, Engineering or closely related field of science.
- Minimum of five (5) years progressively responsible related work experience including handling radioactivity and complying with Federal Drug Administration (FDA) guidelines.
- Experience in radiochemistry, and experience in producing isotopes for medical applications.
- Knowledge of radioanlytical techniques.
- Demonstrated leadership/supervision in a medical production environment is required.
- Demonstrates thorough understanding of principles, practices and procedures within this specialized field leading to completion of moderately complex assignments.
- Grade level to be determined by selected candidate’s overall qualifications.
Preferred Knowledge, Skills, and Abilities:
- Knowledge of FDA guidelines for active pharmaceutical ingredients
- Department of Energy regulation and operation guidelines
- Principles of workplace safety and review
- Calculations associated with the predicting impact of beam on targets
- Radioanalytical detection and monitoring systems
- Targetry and radioanalytical analysis
- Microshield and radiological analysis
- Essential Functions for this position, arm/hand dexterity, climb low to moderate heights, lift (up to) 30lbs, good vision, mental sharpness, alertness, and work with toxic chemicals including acids and bases.
- Valid NYS Dirver's license
At Brookhaven National Laboratory we believe that a comprehensive employee benefits program is an important and meaningful part of the compensation employees receive. Our benefits program includes, but is not limited to:
- Medical Plans
- Dental Plans
- Life Insurance
- 401(k) Plan
- Retirement Plan
- Paid Parental Leave
- Swimming Pool, Weight Room, Tennis Courts, and many other employee perks and benefits
BNL takes affirmative action in support of its policy and to advance in employment individuals who are minorities, women, protected veterans, and individuals with disabilities.We ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process, to perform essential job functions, and to receive other benefits and privileges of employment.Please contact us to request accommodation.
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