Process Chemist, Late Phase, Remote
POINT Biopharma, Canada
Job Description
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- (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 CANADA.
Location of work
The position will be working remotely with the anticipation of travel for team and client meetings. Our business requirements are to work to accommodate Eastern Time Zone. To work in synergy, it is preferred that our applicants can work Eastern Time Zone to accommodate team and client meetings.
Reporting to the Senior Process Chemist, Chemistry Manufacturing Controls, the Process Chemist, Late Phase, will have functional responsibility for authoring and reviewing technical documents (e.g., MBR, change controls, protocols and reports), and supporting the preparation of the quality sections (i.e., Modules 2 and 3) of Common Technical Document (CTD) for regulatory submissions. The Process Chemist will work cross-functionally with the manufacturing and CMC teams in planning, directing, and designing process development up to production scale of POINT’s late phase radiopharmaceuticals.
Objectives
- Work closely with the manufacturing, commercial and regulatory teams to develop manufacturing processes for small volume parenteral performed under cGMP (21 CFR Part 211).
- Support POINT’s late phase programs; analyze experimentation and interpret results; prepare and review technical documents to support CMC regulatory submissions.
Accountabilities
- Collaborate with the manufacturing team, develop phase-appropriate, cGMP production processes.
- Demonstrate technical knowledge and scientific creativity in the identification of Critical Process Parameters (CPPs) and development of a robust manufacturing process for POINT’s radiopharmaceuticals in the late phase programs.
- In accordance with Good Documentation Practices, author and review technical documents including research reports, process development reports, qualification/validation protocols, and documentation for the manufacturing of POINT’s drug products under cGMP.
- Contribute and provide technical support in the preparation and interactions with regulatory agencies regarding drug submissions and responding to inquiries.
- Collaborate with the Manufacturing, QA/QC and Project Management teams, design and maintain a CMC documentation system.
- Act as POINT’s technical expert and provide support on cGMP process development.
- Play a critical role in developing and maintaining good relationships with cross-functional teams, CMOs, vendors, suppliers, and other external partners.
- Provide verbal and written reports and presentations to managers in a clear and concise manner.
- Adhere to all applicable procedures, cGLP, cGMPs, company policies and any other quality or regulatory requirements.
- 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
- MSc. with 3 years professional experience or a PhD in synthetic, organic or medicinal chemistry in a GMP setting are the minimal requirements, but additional experience in a GMP setting is preferred.
- Proficient in all aspects of modern synthetic chemistry including designing and executing multi-step syntheses, crystallization, HPLC purification, and characterization of new compounds using HPLC, NMR and mass spectrometry is required.
- Experience writing technical documents, i.e., process development reports, qualification/validation reports, or CMC regulatory modules associated with IND, NDA, or other regulatory equivalents.
- Ability to work effectively in a multi-disciplinary team setting is required.
- Strong oral and written communication skills required.
- Strong scientific, analytical and project management skills required.
- Experience working with radiochemistry, metal chelators and/or peptides is highly desirable.
Competencies
- High attention to detail, well organized, and highly motivated.
- Excellent ability to multitask and prioritize workload.
- Strong oral and written communication skills, a