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Sr. Director, Engineering

4 months ago

Indianapolis, United States RayzeBio Full time

Job Title: Sr. Director, Engineering

Location: Indianapolis

NH#: 5


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.


Job Description

The Sr. Director of Engineering is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Vice President, Site Head and be responsible for building and leading a multi-functional engineering department in support of clinical development and the commercialization of isotope and radiopharmaceutical drug products. You will spearhead the design and construction of internal and external cleanroom and facility construction projects. You will set and manage capital project budgets and oversee Construction, Architectural and Engineering firms to ensure projects are executed to meet budget and timeline objectives. You will establish and oversee a highly competent engineering department with expertise in a wide range of radiopharmaceutical technologies, validation, facility maintenance and engineering management. You will build an experienced engineering team to manage multiple capital projects to support the commercialization efforts of RayzeBio’s drug product candidates.


Job Responsibilities

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

• Build and manage a team of highly talented engineers responsible for all aspects of engineering, capital projects, validation and facility maintenance.

• Oversee and manage a wide range of engineering capital and facility expansion projects specific to radiopharmaceutical manufacturing.

• Set and manage engineering project budgets and timelines.

• Oversee the design and construction of existing facility expansion and future commercial facility projects.

• Implement engineering and related business systems in alignment with BMS’s corporate objectives.

• Establish an Engineering Services department responsible for maintaining and troubleshooting complex manufacturing equipment and processes, providing technical guidance and support to team members.

• Establish an engineering infrastructure to provide cross departmental project and capital equipment support including but not limited to URS, Purchase, Installation, and Preventative Maintenance.

• Coordination of external vendors, partners and service providers as required.

• Ensure Engineering personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.

• Review, author and/or revise technical documents (SOPs, URS’s, forms, etc.) as needed.

• Ability to travel as required to support job role.


Education and Experience:

• 10+ years’ engineering experience in a cGMP injectable or Radiopharmaceutical environment is required.

• Proven engineering leadership and management experience.

• BS/MS Engineering Degree.


Skills:

• Strong track record managing capital engineering projects and budgets.

• Proven leadership and personnel management experience.

• Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.

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

• Organized and detail oriented.

• Strong time management and organizational skills.

• Strong interpersonal communication skills.

• Motivated, adaptable, and able to work under pressure.