Associate Process Chemist

POINT Biopharma is an innovative, high-performance company focused on a hard problem: creating new cancer therapies that are more effective and have fewer side effects than traditional treatments. Our products are targeted radioligands, a technology that hold significant promise to treat cancer. Our company is growing rapidly: we just announced a phase 3 clinical trial for our novel radioligand based prostate cancer treatment, established our U.S. manufacturing center in Indianapolis, and have a pipeline of next generation oncology products in development. We are a creative and agile team accountable to a high standard: to be uniquely better. If you are searching for new and uniquely better career path, you should consider joining the POINT team.

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 experience in development and scale-up of pharmaceutical manufacturing processes, ideally in the production of radioactive parenteral drug products, and will work in collaboration with team members, other departments, and external partners to ensure successful development, setup, launch and routine manufacturing of drug products from POINT’s Indianapolis facility.

Objectives

• Develop, transfer, scale-up and optimize manufacturing methods associated with the production of radiopharmaceutical drug products.
• Interface with external partners and conduct independent research to ensure that manufacturing equipment and materials are suitable for GMP manufacturing.
• In collaboration with internal stakeholders, define and draft user requirements for production equipment, and consumable materials required for the drug product manufacturing process.
• Identify, collect, and analyze key manufacturing process data, identify trends and opportunities for improvement.
• Conduct process improvement protocols while ensuring that critical process parameters remain in control and the manufacturing process is robust
• Support process automation and improvement initiatives and assess impact of technical changes.
• Develop the knowledge base to become a subject matter expert for the entire radiopharmaceutical manufacturing process and the use and handling of radioactive materials.
• Assist in the preparation and execution of method validation protocols associated with drug products produced at the manufacturing facility in accordance with applicable regulatory guidelines as well as the established Quality Management System.

Accountabilities

• Support the design, qualification, and commissioning of facilities and equipment in relation to parenteral radiopharmaceutical drug product manufacturing.
• Support root cause investigations for process failures, initiate and lead CAPAs in collaboration with QA and CMC teams.
• Support interdepartmental planning and execution of process improvement and validation activities.
• Support the maintenance and calibration of process equipment.
• 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 and a background in mathematics.
• 2 years of relevant industry experience in parenteral drug product manufacturing, and/or process support/development.
• Experience working in a pharmaceutical GMP manufacturing environment is preferred.
• Excellent problem solving, decision-making and technical writing skills.
• Strong organization and communication skills.
• Experience with process automation and aseptic manufacturing is considered an asset.
• Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines.

Benefits

• Eligible for annual incentive bonus plans and stock options
• Health Care Plan (Medical, Dental & Vision) – 85% paid by employer and effective day 1
• Retirement Plan (matching 401k)
• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Voluntary Income Protection – Premiums paid by employ