Associate Process Chemist Jobs

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

• Interface with external partners and conduct independent research to ensure that manufacturing equipment and materials are suitable for GMP manufacturing.
• 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.
• In collaboration with internal stakeholders, define and draft user requirements for production equipment, and consumable materials required for the drug product manufacturing process.
• Conduct process improvement protocols while ensuring that critical process parameters remain in control and the manufacturing process is robust
• Develop, transfer, scale-up and optimize manufacturing methods associated with the production of radiopharmaceutical drug products.
• Identify, collect, and analyze key manufacturing process data, identify trends and opportunities for improvement.
• 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.

Accountabilities

• Support the design, qualification, and commissioning of facilities and equipment in relation to parenteral radiopharmaceutical drug product manufacturing.
• Support interdepartmental planning and execution of process improvement and validation activities.
• Adhere to all applicable procedures, cGMPs, company policies and any other quality or regulatory requirements.
• Support the maintenance and calibration of process equipment.
• Support root cause investigations for process failures, initiate and lead CAPAs in collaboration with QA and CMC teams.

Requirements

• 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.
• 2 years of relevant industry experience in parenteral drug product manufacturing, and/or process support/development.
• BS/BA degree in chemistry, chemical engineering, or a related discipline. Experience with radiopharmaceuticals and/or use of radioactive materials is preferred.
• Strong organization and communication skills.
• Excellent problem solving, decision-making and technical writing skills.
• Experience working in a pharmaceutical GMP manufacturing environment is preferred.
• Strong quantitative reasoning skills and a background in mathematics.

Benefits

• Income Protection Insurance – (Life AD&D, Short & Long-term disability) – 100% employer paid
• Voluntary Income Protection – Premiums paid by employee
• Health Care Plan (Medical, Dental & Vision) – 85% paid by employer and effective day 1
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• Eligible for annual incentive bonus plans and stock options
• $500 fitness reimbursement per year
• Retirement Plan (matching 401k)
• $100 cell phone reimbursement per month

All applicants who are offered employment with POINT Biopharma will be subject to a background investigation. Offers of employment are contingent on the successful completion of a background investigation conducted in accordance with POINT Biopharma policy and state law.
POINT Biopharma does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status.
We do not accept unsolicited inquiries or resumes from agencies.