Quality Control Scientist

**35Pharma **is a clinical-stage biopharmaceutical company that designs and develops innovative therapeutics for life threatening lung diseases, and musculoskeletal and metabolic disorders. We believe in connecting rigorous science with our innate sense of urgency to rapidly generate breakthrough therapies for patients in need to better quality of life. Our highly qualified team of drug developers and company builders has a track record of advancing complex biologics from discovery through clinical trials. Our R&D facilities are located in the heart of **Montréal, Canada**, and comprise laboratory space for pre-clinical research as well as manufacturing development that bolster our mission to serve patients in need.

**Role**:
You will love this role if you have a passion for innovative science and medicine, you thrive in a fast-paced environment and enjoy contributing to drug development in an integrated communicative team environment.

The **Quality Control Scientist** role is to lead new complex protein industrialization efforts taking the responsibility of developing an adequate analytical control panel and its execution, from R&D to QC level. The incumbent will participate in the analytical development planning ensuring that assays are fit for purpose throughout the assay life cycle and are supportive of the necessary control for manufactured proteins. The QC Scientist will use her/his experience in QC laboratory operations to facilitate assay technology transfers to QC labs contracted to test clinical trial material. In addition, the incumbent will lead the setting of drug substance and drug product specifications for investigational products as well as the preparation of certificates of analysis and testing. A related responsibility is to organize stability data and its trending. The QC Scientist will conduct technical investigations to resolve non-conformities and out of trend and/or out of specification results, as well as have an active participation in the drafting and revision of analytical regulatory sections. Other responsibilities include using best scientific/industrial/regulatory practices in all projects and integrating the analytical development efforts with the process development team.

This is a full-time position that reports to the Associate Director of Analytical Development and is based in **Montreal, QC, Canada**.

**Duties and responsibilities**:

- Lead analytical assay qualification / pre-validation in the scope of transfer to QC laboratories
- Lead product specification setting, stability study data trending, and reference standard qualifications
- Responsible for conducting and/or organizing analytical investigations within CMC
- Responsible for analytical technology transfer to QC laboratories
- Lead the development of the assay panel to support product quality during manufacturing
- Participate to product characterization efforts.

**Qualifications**:

- A minimum of a Bachelor of Science (B.Sc.) in biology, biochemistry or equivalent with 10 years of relevant experience.
- Practical experience with the development of protein product assays and their validation
- Expertise with Good Manufacturing Practices (GMP) and pharmaceutical regulations
- Expertise in QC lab operations, including release testing under specification, stability studies, reference standard qualifications, and investigations of non-conformities
- Knowledgeable of regulatory (FDA, Health Canada, EMA) requirements for analytical and quality control activities
- Knowledgeable in regulatory analytical section drafting and revision
- Ability to work in cross-functional teams and in a fast-paced environment
- Experienced in problem solving and troubleshooting
- Excellent verbal and written communication skills

**Perks**:

- Comprehensive group insurance plan
- Paid public transit
- Beautiful office space in Montreal’s Old Port
- Onsite yoga and healthy snacks
- A team and culture committed to learning and high performance

**Contact**:
**Job Types**: Full-time, Permanent

**Benefits**:

- Commuter benefits
- Company events
- Dental care
- Disability insurance
- Employee assistance program
- Extended health care
- Flexible schedule
- Life insurance
- Paid time off
- Vision care
- Wellness program

Schedule:

- Monday to Friday

**Education**:

- Bachelor's Degree (required)

**Experience**:

- development and validation of protein product assays: 5 years (required)

Work Location: In person