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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. POINTs active clinical trials include FRONTIER, a phase 1 trial for PNT2004, a pan-cancer program targeting fibroblast activation protein- (FAP-), 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 Chemist, Process Chemistry, the successful candidate will have experience in development and scaleup 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 POINTs Indianapolis facility.

Objectives

• Develop, transfer, scale-up and optimize manufacturing methods associated with the production of radiopharmaceutical drug products.
• Design, draft and execute robustness protocols to ensure that production methods are well understood and characterized.
• Conduct process improvement protocols while ensuring that critical process parameters remain in control and the manufacturing process is robust.
• Interface with external partners and conduct independent research to ensure that manufacturing equipment and materials are suitable for GMP manufacturing.
• Conduct independent research to develop a deep understanding of the synthesis process and process components. 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.
• 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

• Ensure that robustness and other development protocols are designed, drafted, executed, and reported appropriately.
• Report and present research findings regarding radiochemistry and process components to company stakeholders and executive teams.
• Support interdepartmental planning and execution of process improvement and validation activities.
• Support the design, qualification, and commissioning of equipment in relation to parenteral radiopharmaceutical drug product manufacturing.
• Lead development of standard operating procedures and operator training on manufacturing equipment.
• Support root cause investigations for process failures, initiate and lead CAPAs in collaboration with QA and CMC teams.
• 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. MS or PhD in chemistry or related discipline is preferred.
• Strong quantitative reasoning skills and a background in mathematics.
• BS/BA and 5-8 years of relevant industry experience in process support/development, or MS/PhD in a hands-on chemistry subdiscipline with 0-2 years industry experience. Prior work with radiopharmaceuticals and/or use of radioactive materials is preferred.
• Experience working in a pharmaceutical GMP manufacturing environment is preferred, but not required.
• Excellent problem solving, decision-making and technical writing skills.
• Proven ability to perform hands-on work and literature research independently, with 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 is an asset.
• To be considered, applicants must be legally entitled to work in the USA.

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 organization that will change the course of cancer therapies. and help thousands of people each year
• You will be challenged, and are expected to challenge us, as part of a results-oriented, high performance team, where everyone leaves their egos at the door and lets the best ideas win
• You will be provided the opportunity to participate in the financial value creation that occurs as POINT grows and becomes a mature pharmaceutical company
• Most importantly, you will spend everyday working on something important

If what we are saying resonates with you, please submit a resume.

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 employee
• Paid Time Off (Vacation, Personal Days, Sick Days & Public Holidays)
• $500 fitness reimbursement per year
• $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.