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Production Operator II

2 months ago

Indianapolis, United States RayzeBio Full time

Job Title: Radiopharmaceuticals Production Operator II

Location: Indianapolis

ID#: R13


Background

RayzeBio is a dynamic biotechnology company headquartered in San Diego, CA. Launched in late 2020 and recently acquired by Bristol Myers Squibb (BMS) as a wholly owned subsidiary, the company is focused on improving survival of people with cancer by harnessing the power of targeted radioisotopes. RayzeBio will operate as a standalone entity within the BMS organization, maintaining its biotech culture with the opportunity to leverage the best-in-class oncology capabilities of BMS. RayzeBio is developing innovative drugs against targets of solid tumors. The lead asset, RYZ101, is in Phase 3 testing for patients with gastroenteropancreatic neuroendocrine tumors (GEP-NETs), as well as earlier stage testing for patients with small cell lung cancer (SCLC). Led by a successful and experienced entrepreneurial team, RayzeBio aims to be the global leader in radiopharmaceuticals.


Summary

The Radiopharmaceuticals Production Operator will be an integral part of bringing RayzeBio’s innovative drug products to patients in need. As the Production Operator, you will play an active role in daily operations, striving to ensure each batch is right the first time and that the production area is kept in order at our manufacturing site in Indianapolis IN. You will be responsible for the production of RayzeBio drug products, strictly complying with good manufacturing practice and aseptic requirements. Additionally, you will be the front line in ensuring compliance with radiation safety requirements on the production floor.


As RayzeBio expands the production site and its portfolio of new products, the Production Operator will support validation work for future company initiatives, and support management with internal projects and new hire training. The Radiopharmaceuticals Production Operator will report directly to the Production Manager. Operator level will be evaluated with experience and qualifications.


Job Responsibilities

Essential duties and responsibilities include the following. Other duties may be assigned.

• Execute production of RayzeBio drug products (including raw material preparation, line clearance and cleaning, equipment/instrument setup, etc.) while ensuring compliance with cGMP, aseptic practice, and management expectations.

• Support Production Management with training of new hires.

• Support and execute validation activities for clinical and commercial manufacturing.

• Support process improvements, both internally and cross-functionally, as opportunities present.

• Support department with inventory management, including cleaning supplies and personal protective equipment (PPE).

• Support day-to-day production operations, and upkeep of the production area.

• Promote a culture of safety and compliance with EHS and Radiation Safety programs.



Education and Experience

• Previous experience working in a laboratory setting, particularly with pipetting and laminar flow hoods.

• 1 – 4 years’ experience operating in a GMP environment.

o Experience operating aseptically within ISO 7/Class C strongly preferred

• Associate’s or Bachelor’s Degree in a STEM field is preferred

• Strong attention to detail and precision in liquid handling

• Experience with radiochemistry and/or radiopharmaceuticals strongly preferred


Skills and Qualification

• Fluency in English.

• Strong knowledge of cGMP and aseptic practice.

• Knowledge of injectable and/or radiopharmaceutical drug product manufacturing.

• Excellent professional ethics, integrity, and ability to maintain confidential information.

• Well organized and detail oriented.

• Strong interpersonal communication skills.

• Motivated, adaptable, and able to work under pressure while meeting the needs of the production schedule.



The starting pay rate takes into account characteristics of the job, such as required skills and where the job is performed.

Final, individual compensation will be decided based on demonstrated experience.

Benefit offerings are subject to the terms and conditions of the applicable plans then in effect and may include the following: Medical, pharmacy, dental and vision care. Employee assistance programs (EAP) and a 401(K). Financial protection benefits such as short- and long-term disability, life insurance and supplemental health insurance. Work-life programs include paid national holidays and optional holidays, Global Shutdown days between Christmas and New Year’s holiday, up to 120 hours of paid vacation, and sick time off. Parental, caregiver, bereavement, and military leave. Other perks like tuition reimbursement.