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Senior Scientist, Chemistry and Conjugation, Process and Analytical Development
2 months ago
Maintain process knowledge database for Chemistry and Conjugation including related raw materials, scale, impurities and data analysis using statistical or other methods. In collaboration with CMO partners, conceive and devise experiments to test process changes and analyze the results through statistical means or otherwise. A familiarity with OFAT and DoE experimental design and analysis is a bonus.
Provide technical support for Chemistry and/or Conjugation process-related investigations, product impact assessments, change control assessments, CAPA assessments, raw material qualification, etc.
Work collaboratively with Analytical Development, Project Management, Manufacturing Operations, QA, QC, Regulatory, and Contract Manufacturers to achieve corporate objectives.
Clearly and efficiently communicate in both written and verbal forms with managers, peers, and external partners.
Visit CMO sites when needed to inspect manufacturing readiness and process performance, perform PIP and troubleshooting duties as necessary.
Draft and review technical and regulatory documents for process and analytical development activities to support regulatory filing and inspection.
Qualifications and Experience- A PhD or MSc in Synthetic Organic Chemistry, Synthetic Method Development or related discipline or BSc in Chemistry with at least 5 years of specifically related industrial experience in Process and Analytical Development.
- Demonstrated mastery of multi-step synthetic campaigns to complex and/or difficult to purify and characterize molecular targets.
- Proven ability to rationally analyze and characterize chemical entities, including analytical method optimization and qualification.
- Proven track record in efficient resolution of technically challenging problems.
- Strong interpersonal and team skills, including the ability to work both collaboratively and independently in a fast-paced cross-functional environment.
- Experience working with 3rd party CROs and CMOs to develop processes and analytical methods to support GMP manufacturing.
- Pre-existing knowledge of process development, characterization, scale-up and manufacturing in the cGMP environment is a benefit.
- Strong data management skills; familiarity with statistical analysis of process information is a benefit.
- Familiarity with protein expression and handling and/or bioconjugation techniques is a benefit.
- Excellent oral and written communication skills, including the ability to integrate complex data to produce clear and accurate reports and presentations.
We offer a comprehensive total rewards package, which includes competitive salaries, generous benefits, an outstanding work environment, and excellent opportunities for professional growth. We regularly benchmark our compensation against leading biotechnology companies in our geographies.
The Canadian base salary range for this full-time position is $, - $, + bonus + equity + benefits. Our salary ranges are determined by role, level, and location. The range displayed on each job posting reflects the minimum and maximum target for new hire salaries for the position across all Canadian locations.
Within the range, individual pay is determined by a variety of factors and the salary offered may vary depending on the successful candidate’s location and qualifications (including, but not limited to, job-related knowledge, education, training, skills, and experience).
Please note that the compensation details listed in role postings reflect the base salary only, and do not include bonus, equity, or benefits.
Our team enjoys:
- Industry leading vacation and paid time off
- Excellent health and wellness benefits
- Zymelife health and wellness benefits
- Paid time off to volunteer in your community
- Matching country specific pension savings program
- Employee Share Purchase Program
- Employee Equity Program
All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin or disability.
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