Principal Scientist, Process Chemist

3 weeks ago

Toronto, Canada Lilly Full time

At Lilly, we unite caring with discovery to make life better for people around the world. We are a global healthcare leader headquartered in Indianapolis, Indiana. Our employees around the world work to discover and bring life-changing medicines to those who need them, improve the understanding and management of disease, and give back to our communities through philanthropy and volunteerism. We give our best effort to our work, and we put people first. We’re looking for people who are determined to make life better for people around the world.

**About POINT Biopharma**:
POINT Biopharma Global Inc. is a globally focused radiopharmaceutical company building a platform for the clinical development and commercialization of radioligands that fight cancer. Recently acquired by Eli Lilly and Company, 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 is a wholly owned subsidiary of Eli Lilly and Company.

**Position Summary**:
Reporting to the Senior Director, CMC, Late Phase, the Principal Scientist 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 Principal Scientist 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.

**Roles and Responsibilities of the Position**:

- Work closely with the manufacturing, commercial and regulatory teams to develop manufacturing processes for small volume parenterals 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.
- Collaborate with the manufacturing team to 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 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.

**Required Qualifications**:

- MSc. with 3 years professional experience or a PhD in synthetic organic or medicinal chemistry in a GMP setting.
- 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.
- Strong oral and written communication skills.
- Strong scientific, analytical and project management skills.

**Additional Preferences**:

- Additional experience in a GMP setting is preferred.
- Experience working with radiochemistry, metal chelators and/or peptides is highly desirable.
- Experience in an FDA regulated environment a plus.

**Physical Demands/Travel**:

- Position is working remotely.
- The physical demands here are representative of those that must _be_ met _by an_ employee to_ successfully perform the essential functions of this job._

**Work Environment**:

- Position works remotely.
- The_ _work_ _environment_ _characteristics_ _descri_b_ed_ _here_ _are_ _representative_

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