Technical Operations Lead

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.

Overview

Reporting to the Manager, Technical Operations, the successful candidate will have the knowledge and experience to support both technical development as well as GMP manufacturing operations of radioisotopes and radioactive drug products at POINT’s Indianapolis facility.

Objectives

• Serve as a subject matter expert for the end-to-end radioisotope and radiopharmaceutical manufacturing process.
• Interface with external partners to ensure that manufacturing equipment and materials are suitable for GMP manufacturing.
• In collaboration with other members of the Technical Operations team ensure that: Development and/or GMP protocols are executed as written and results are reported per GLP/GDP guidelines.
• Identify, collect, and analyze key manufacturing process data, identify trends and opportunities for improvement.
• In collaboration with the Quality assurance team, ensure that equipment/manufacturing materials onboarding and production processes/methods are formalized per GMP requirements.
• Support process automation and improvement initiatives and assess impact of technical changes.
• Assist in the execution of method validation protocols and DMF submission associated with radiopharmaceuticals produced at the manufacturing facility in accordance with applicable regulatory guidelines as well as the established Quality Management System.

Accountabilities

• Support development, optimization and scale-up of isotope manufacturing activities, including training of team members on manufacturing techniques, laboratory techniques, and equipment use.
• Lead the development of process workflows and process optimization with considerations around GMP requirements, sterility assurance and the demands of the product.
• Lead studies and initiatives focused on optimizing time, equipment and personnel involved in direct and indirect manufacturing activities.

• Lead implementation of new technology and equipment within the drug product manufacturing process.
• Design and execute development experiments, in accordance with internal procedures.
• Support project management activities, including the creation of timelines, workflows, risk assessments, and implementation plans.
• Support root cause investigations for process failures, initiate and lead CAPAs in collaboration with QA, manufacturing and CMC teams.
• Support interdepartmental planning and execution of process improvement and validation activities.
• Support the onboarding, maintenance, and calibration of process equipment. Help to develop SOPs on equipment use and troubleshooting.
• Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.

Requirements

• BS/BA degree in chemistry, chemical engineering, or a related discipline. Experience with radiopharmaceuticals and/or use of radioactive materials is preferred.
• Strong quantitative reasoning skills.
• 5 years of relevant industry experience in pharmaceutical manufacturing, and/or process support/development.
• Experience working in a pharmaceutical GMP manufacturing environment.
• Excellent problem solving, decision-making and technical writing skills.
• Strong communication skills.
• To be considered, applicants must be legally entitled to work in the USA.

Benefits

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 organ