Director, Medical Isotope Manufacturing

POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. POINT aims to transform precision oncology by combining a portfolio of targeted radioligand assets, a seasoned management team, an industry-leading pipeline, in-house manufacturing capabilities, and secured supply for medical isotopes including actinium-225 and lutetium-177. POINT’s active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein-α (FAP-α), and SPLASH, the phase 3 trial for PNT2002 for people with metastatic castration resistant prostate cancer (mCRPC) after second-line hormonal treatment.

TO BE CONSIDERED, APPLICANTS MUST BE LEGALLY ENTITLED TO WORK IN THE USA.

Location: Indianapolis, IN. Completed in Sept 2021, POINT's Indianapolis site is one of the largest state-of-the-art radiopharmaceutical manufacturing facilities in the world - almost as large as one and a half football fields.

Reporting to the Senior Vice President, US Manufacturing Operations, the Director, Medical Isotope Manufacturing will oversee all aspects of medical isotope production and supply, coordinate logistics and supply chain, and lead a team to provide internally produced and externally supplied medical isotopes across POINT’s product pipeline.

LOCATION: Indianapolis

In this role, you will be expected to:

• Demonstrate strong leadership and management capabilities focusing on operational excellence, supply requirements and quality expectations.
• Oversee technical transfer of lanthanide separation and recovery technology, and development of routine separation, purification and fill-finish procedures following GMP.
• Direct the medical isotopes team, including day-to-day oversight of manufacturing, supply chain, logistics, safety and quality.
• Lead all operational efforts and identify process improvements to increase efficiencies and support strategic growth.
• Develop, implement, and oversee process workflows, production operations, schedules, staffing levels, and equipment utilization for medical isotopes to ensure the required production output is achieved.
• Collaborate and communicate effectively with a multidisciplinary team, including Facilities, Engineering, QA, QC, and Manufacturing to integrate medical isotope operations with finished product manufacturing and implement production and quality improvements.
• Drive strategy and activities related to demand planning, procurement management, and management of vendors, service providers, and logistics to ensure just-in-time manufacturing.
• Direct annual, quarterly and weekly forecasting and modeling of isotope requirements from internal production and external vendors to ensure seamless supply for drug product manufacturing.
• Contribute to regulatory submissions and program planning for POINT’s clinical and commercial pipeline.
• Set KPIs for isotope manufacturing, communicate KPIs and key program updates to stakeholders, and drive improvements in quality, safety, and productivity to ensure KPIs are met.
• Interact and maintain strong collaborative relationships with stakeholders including business partners, industry partners, and service providers.

Requirements

• MSc. in Chemistry, Biochemistry, or related discipline, or BSc. with at least 10-15 years cumulative experience in manufacturing operations within a GMP pharmaceutical or radioisotope manufacturing setting.
• Minimum of 6 years of supervisory or management experience overseeing GMP pharmaceutical manufacturing operations. Experience with radiopharmaceuticals or radioisotopes is an asset.
• Experience with lanthanide separation techniques, rare earth metal separation technologies (radioactive/non-radioactive), radiochemistry or radiopharmaceuticals is highly desired.
• Experience with chromatography separation, liquid/solid extraction, electrochemistry or amalgamation/cementation processes is an asset.
• Hands-on experience utilizing lean manufacturing principles for continuous process improvements (e.g. Six Sigma, Lean Manufacturing, 5S) is an asset.
• Demonstrated strategic planning skills, strong leadership skills, effective communication skills, high level of drive, integrity and energy.
• Ability to build a strong positive team environment, mentor and develop direct reports, drive results, identify, attract, and retain talent, and build a team.

Why joining POINT today will be the right career move for you:

There is no shortage of demand for smart, qualified and hardworking people like yourself – and we strongly believe POINT is the right career move for you. Here is why:

• You will help establish and define an organizatio