Location: Indianapolis
Job Summary
The Director, Engineering Innovation is an integral part of bringing RayzeBio’s innovative drug products to patients in need. In this role, you will report directly to the Sr. Director, Engineering and be primarily responsible implementing RayzeBio’s vision for growth and leading a team of Engineers to achieve commercialization objectives at the site. The Director, Engineering Innovation will oversee and lead a team of Engineers to successfully design and implement novel Radiopharmaceutical technologies including but not limited to custom Hot Cells, robotics, automation and digitization to support commercialization at the Indianapolis site(s). Additional responsibilities will include setting and managing capital project budgets and working with architectural and engineering firms and specialty equipment manufactures to achieve our technology and commercialization goals.
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 a wide range of engineering disciplines including electrical, automation, & mechanical to enable digitization.
- Manage engineering capital and facility expansion projects specific to innovative isotope and drug product radiopharmaceutical manufacturing.
- Establish and manage project timelines, budgets and KPI’s.
- Participate in the management and oversight of capital construction projects related to commercialization efforts at the Indianapolis site(s).
- Design and implement engineering and related functional systems in alignment with BMS and RayzeBio objectives.
- Work with Quality, Digital IT, Validation, Engineer Services and Facility Engineering counterparts to successfully develop and implement novel radiopharmaceutical technologies.
- Coordinate and manage external vendors, partners and service providers as required for the design and implementation of novel radiopharmaceutical isotope and drug product equipment technologies.
- Ensure Engineering personnel comply with site EHS and Radiation Safety programs and promote a culture of safety.
- Critically evaluates and interprets current trends. Contributes to vision for functional / regional / departmental strategy
- Review, author and/or revise technical documents (SOPs, URS’s, forms, reports, 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.
- Demonstrated experience implementing automation and digitization projects.
- BS/MS Engineering degree.
Skills:
- Strong track record managing budgets and innovative engineering projects.
- Proven leadership and personnel management experience.
- Strong knowledge of injectable and/or radiopharmaceutical drug product manufacturing.
- Strong knowledge of Automation software platforms and GMP and data integrity controls in automation equipment.
- 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.
Physical Requirements:
- Standard office environment coupled with GMP production and facility environment.
- Responsibilities also include the ability to lift up to 50 lbs., walk, bend, stoop, push, pull, reach, and climb stairs with or without accommodation.
- Ability to sit or stand for long periods of time while performing duties.
- Must be willing to wear personal protective equipment (PPE) as required.
- Must be comfortable working with radioactive materials.
This is a position that requires working in a laboratory environment, protective clothing, gloves, and safety glasses are required while working in a laboratory environment with radioactive materials.
Work Environment
The noise level in the work environment is usually moderate.
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