Analytical Scientist, Cmc

2 weeks ago

Toronto, Canada POINT Biopharma Full time

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 CANADA.

Location of work

The position will be working remotely with the anticipation of travel for team and client meetings. To work in synergy, it is preferred that our applicants are working within the same Eastern Time Zone to accommodate team and client meetings.

Reporting to the Senior Manager, Translational Radiochemistry, the Analytical Scientist, Translational Radiochemistry will manage and lead the analytical chemistry laboratory and team members in the development and validation of analytical methods to support the development of radiopharmaceutical manufacturing processes for clinical development. They will be knowledgeable in applicable regulatory guidance and in methodologies of the development of analytical methods for the testing of radiopharmaceuticals.

Objectives
- Develop analytical methods for the testing of POINT drug products, including chromatography methods (i.e. HPLC, TLC and GC) and spectroscopy methods (i.e. gamma spectroscopy, mass spectroscopy) according to phase appropriate guidelines (e.g. cGLP, cGMP)
- Manage and lead the analytical chemistry laboratory and team members to effectively execute day-to-day development and validation activities
- Prepare standard test methods and method validation protocols in accordance with appliable compendial guidelines (e.g. USP, EP and ICH).
- Execute approved method validation protocols.
- Provide technical expertise as required for the development, troubleshooting and tech transferring of analytical methods to external vendors / partners
- Review experimental data both internally and from external vendors / partners. Summarize and interpret results, relaying findings through summary reports, technical documents, or presentations.

Accountabilities
- Ensure analytical methods are designed and validated per phase appropriate requirements while meeting project timelines
- Mentor, manage, and train a team of analytical chemists
- Adhere to all applicable procedures, cGLP, cGMPs, company polies and other quality or regulatory requirements.
- Maintain good relationships with partners, CMOs, vendors and suppliers.
- Embody and promote a quality culture and "right-the-first-time" approach to all activities
- Work well in a fast-paced environment
- Perform other duties as assigned
- Prepare and deliver presentations for internal and external team meetings.
- Author development reports, manuscripts for publication in journals, and patents.

**Requirements**:

- BS/BA or MSc degree in chemistry or a related discipline.
- 7+ years of relevant industry experience in analytical development, validation, and testing in a GMP setting.
- Experience leading teams and mentoring and coaching others to achieve results.
- Proficient in modern analytical chemistry including developing, validating, and executing methods using TLC, HPLC/UPLC, GC, NMR and mass spectrometry
- Experienced in quality control testing of radiopharmaceuticals is considered an asset.
- Hands-on experience with radiopharmaceutical testing including GC, Radiometric TLC and HPLC-UV with radiometric detection of PET radioisotopes (F-18, Ga-68, Cu-64) and/or theranostic radioisotopes (Lu-177, Ac-225, Tb-161) is considered an asset.
- Knowledge of environmental health and radioprotection requirements are considered assets.
- Proven ability to work independently with strong organization and communication skills.
- Demonstrated ability to successfully prioritize projects and manage timelines in a fast-paced environment.
- Functional knowledge of GMPs and applicable FDA, EMA, Health Canada, USP, ICH and PDA guidelines.
- Position will require up to 20% of travel within North America and abroad into the EU. A valid passport and eligible to travel into these countries are required.

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 t

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