Senior Chemist, Analytical Chemistry and Quality Control

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 Supervisor, Analytical Chemistry, the Senior Chemist, will serve as a subject matter expert with responsibility for problem solving and creating unique solutions for analytical chemistry problems and applications. This entails performing method development as well as authoring and reviewing technical documents (e.g., standard test methods, performance qualifications, change controls, analytical method validation protocols, stability protocols, and various reports), authoring and reviewing investigations (deviations, non-conformances, out-of-specifications, aberrant results, etc.), and troubleshooting and executing performance qualifications on instrumentation.

The position is onsite and requires hands-on laboratory work.

Objectives

• Responsible for writing, editing, and reviewing analytical method documents, including protocols, procedures, and reports.
• Training members of the laboratories on analytical methods, instrument operation and maintenance, and troubleshooting.
• Contributing to routine testing of Drug Product, Drug Substances and intermediates, excipients, and raw materials.
• Collaborate with QA, Process Chemistry, CMC, and Regulatory colleagues on providing analytical services for experiments, investigations of aberrant results and impurities of interest, and on the release and stability specifications for starting materials, intermediates, drug substances, and drug products.
• Review and approve experimental data both internally and from external vendors/partners. Summarize and interpret results, relay findings through summary reports, technical documents, and presentations.
• Review and provide technical support to method validation protocols in accordance with applicable compendial monographs (e.g., USP and EP), ICH guidelines, industry publications (e.g., PDA), and various focus groups by industry associates and government agencies (e.g., IAEA, FDA, etc.) as well as POINT’s established Quality Management System.

Accountabilities

• Ensure analytical methods associated with the testing of POINT drug products, including chromatography methods (i.e., HPLC, TLC, and GC) and spectroscopy methods (i.e., gamma spectroscopy, mass spectrometry) are developed according to phase appropriate guidelines for late clinical phase to commercial programs.
• Adhering to all applicable procedures, cGLP, CGMPs, company policies and any other quality or regulatory requirements.
• Play a critical role in developing and maintaining good relationships with cross-functional teams, CMOs, vendors, suppliers, and other external partners.
• Embody and promote a quality culture and “right-the-first-time” approach as part of all activities
• Work well in a fast-paced team environment
• Perform other duties as assigned.

Requirements

Education and Experience:

• Minimum: B.Sc. in STEM with 10 years of professional GMP pharma experience
• Preferred: M.Sc. or Ph.D. in Chemistry with 5 years of professional GMP Radiopharma experience
• Proficient in all aspects of modern analytical chemistry including developing, validating, and executing methods using TLC, HPLC/UPLC, NMR, LC-MS, ICP-MS, and gamma spectroscopy is required.
• NRC Authorized User status is considered an asset but not a requirement.
• Strong oral and written communication skills required.
• Experience developing and validating methods for small molecules, peptides, and excipients.
• Ability to work effectively in a multi-disciplinary team setting is required.
• Strong scientific, analytical and project management skills required.
• Experience developing methods for radi