The Manager, Clinical Monitoring will be responsible for clinical monitoring activities at clinical sites to ensure compliance with the clinical protocol and study procedures, as well as all applicable regulations, guidelines, quality industry standards, internal standard operating procedures (SOPs) and policies. The Manager, Clinical Monitoring will be responsible to conduct on-site and remote monitoring visits, to review and collect sites essential documents required for the trial master file (TMF), and be the primary point of contact with sites for protocols, recruitment status, and essential documents collection. The Manager, Clinical Monitoring will oversee the CRAs’ performance and workload, ensure training and onboarding, and contribute to the selection of new CRAs. This is a full-time position based in Montreal.

Key Responsibilities:

• Acts as primary point of contact for clinical sites for the conduct of study protocols.
• Supports clinical sites with their patient recruitment initiatives and site-specific recruitment plans.
• Conducts on-site and remote monitoring visits (site qualification visit, site initiation visit, interim monitoring visit, and site close-out visit).
• Prepares or reviews confirmation and follow-up letters to the investigators and monitoring visit reports.
• Prepares and ensures compliance with clinical monitoring plan.
• Participates in the preparation and review of study documents such as clinical protocol, informed consent form, laboratory manual, pharmacy manual, recruitment plan, etc.
• Participates in the planning and conduct of investigator’s meeting.
• Ensures review, collection, and tracking of sites’ essential documents as well as reconciliation with the TMF.
• Conducts co-monitoring visits with contract research organizations (CROs) CRAs or independent CRAs, as necessary.
• Ensures appropriate issue escalation of findings related to the quality of performance of clinical monitoring or site management activities.
• Implements corrective actions and/or training related to clinical monitoring activities.
• Conducts regular CRA group meetings and maintains one-on-one communication with CRAs.
• Interviews, evaluates, and selects new CRAs.
• Conducts orientation of new CRAs and provides continuous training.
• Acts as line manager for CRAs, conducts performance evaluation, and sets-up/reviews objectives.
• Ensures CRAs are meeting performance and quality standards, and takes appropriate remedial actions as required.
• Travels 30% of the time to conduct on-site monitoring visits or to accompany CRAs for co-monitoring visits.
• Supports the clinical sites during regulatory inspections and audits.
• Participates in the development of clinical monitoring SOPs, tools, and templates.
• May contribute to additional clinical operations activities as deemed necessary to ensure the clinical program success.

Qualifications:

• Bachelor’s degree in health sciences, nursing degree, or equivalent experience.
• Minimum of 2 years’ experience in a pharmaceutical or biotechnology company or CRO, in a clinical research associate role conducting on-site monitoring visits.
• Minimum of 3 years experience in a Sr CRA, clinical trial management, or project management role in phase 1-3 multicenter clinical trials in a pharmaceutical or biotechnology company, including experience in a CRA line manager role.
• Excellent interpersonal skills, strong written and verbal communication (French and English), and strong presentation skills necessary to meet the needs of various audiences. (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate).
• Ability to build effective relationships with site personnel, CRO and vendors staff, and colleagues.
• Superior problem solving, deductive reasoning and decision-making skills.
• Excellent time management and organizational skills, ability to prioritize tasks and accomplish set goals efficiently.
• Excellent attention to detail and ability to maintain detailed and accurate records.
• Excellent interpersonal and communication skills.
• Ability to work independently.
• Excellent knowledge and understanding of the regulatory requirements and good clinical practices.
• Demonstration of the highest ethical standards, active promotion of trust, respect, and integrity.
• Proficiency in required softwares (Word, Excel, Power Point), clinical trial systems (i.e., EDC, eTMF, IRT, eCOA) and computer skills.
• Availability to travel to clinical sites in North America.

Next Steps:

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting MCM0514 ” in the subject line – we are looking forward to hearing from you!

The Research Associate, Analytical Development will be responsible for executing the development / implementation / optimization of assays necessary for assessing protein characteristics. Another key responsibility is to execute routine execution of platform tests necessary to assess the quality of manufactured lots and to support discovery and process development activities. Additional responsibilities will be to participate in the pre-validation of developed assays, using defined scientific and regulatory practices, to perform the trending of data, and to write and/or review analytical documentation. The incumbent will also participate in the development of product formulation studies and stability studies. 

You will love this job if:

• You thrive in a fast-paced environment with lots of responsibility and opportunity to learn.
• You are a self-starter who enjoys working as a team player and value solid communication.

Key Responsibilities:

• Analyze recombinant protein candidates produced from mammalian cells using typical assays for protein characterization (e.g.: HPLC, CE, SDS-PAGE, DLS, ELISA).
• Execute the implementation of analytical assays for R&D purposes as well as for transfer to quality control laboratories.
• Participate to the design and execute product stability studies.
• Analyze experimental data and properly document experiments (electronic lab notebook and records).
• Participate in the development of protein formulation chemistry and the execution of required analyses.
• Generate protocols and reports on performed experiments.
• Perform routine laboratory equipment maintenance.
• Participate in technology transfer activities, as required.

The successful candidate will exhibit the following minimum profile:

• At a minimum, an undergraduate level (B.Sc.) in biochemistry, biotechnology, life sciences or equivalent.
• At least 3 years of experience in the performance of analyses including data interpretation on proteins.
• Experienced with at least one of these types of analyses: HPLC, Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS) and immunological techniques (ELISA).
• Track record demonstrating to be meticulous and detail oriented.
• Knowledge of analytical technologies for proteins.
• Knowledge of the current Good Manufacturing Practices (cGMP) is an asset.

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

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting RAAD1114” in the subject line – we are looking forward to hearing from you! 

35Pharma is a fast growing, values-driven biotechnology company based in Montreal, Canada, currently looking for a highly motivated and pro-active Discovery Scientist who will join our growing team in our mission to develop medicines that radically transform patients’ lives.

In close collaboration with your protein engineering and production colleagues, you will be in charge of designing and developing new methods for the characterization of our pre-clinical drug candidates as well as elaborating functional screening assays and target validation in relevant in vitro models.

This is an opportunity to play an integral part in progressing drug candidates through the discovery stage towards patients worldwide. The position would be an excellent fit for early career professionals looking to gain knowledge within the field of pharmaceutical biotechnology or experienced professionals ready to take on a leadership role within discovery and/or preclinical research.

You will love this job if:

• You have a passion for science and drug development
• You thrive in a fast-paced environment with lots of responsibility and opportunity to learn
• You are a self-starter who enjoys working as a team player and value good communication

Key Responsibilities:

• Propose new screening concepts and new target proposals related to our areas of interest
• This position requires thorough hands-on knowledge of cutting-edge molecular and cellular techniques. Expertise in immunology an asset.
• Collaborate with other scientists to bring new innovative, approaches to the group
• Collaborate with the leadership team to formulate short- and long-range goals for the scientific operation of the Facility
• Analyze data, prepare presentations and reports and present to colleagues and management
• Work closely with members of other departments to ensure that a coordinated effort can be made to rapidly advance new projects to the clinic
• Train and coordinate the activities of the research associates to achieve the company’s objectives

The successful candidate will exhibit the following minimum profile:

• Life Science PhD (Biology, Pharmacology, Medicine, Biochemistry, etc.)
• Strong background in molecular biology and cell culture
• Experience in protein biochemistry, including expression and purification of recombinant proteins
• Familiarity with procedures of animal experiments
• Flexible, independent and self-motivated, able to handle multiple tasks and priorities, ability to adapt
• Highly meticulous with excellent attention to detail
• Very good oral and written communication skills for effectively interfacing with all levels of management and departments within the company
• An unwavering commitment to the highest quality of work, research ethics and willingness to learn
• Excellent written and verbal communication skills (French and English). (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate)

Any of these qualifications in addition would be a huge plus:

• Documented industry experience and successful track record, particularly within assay development and validation
• Significant experience with cell-based functional assays and protein function methods (BLI, ELISA, reporter-based assays)
• Experience in pharmacokinetic methods and analysis
• Background in cardiopulmonary or cardiometabolic diseases

Perks:

• Generous private health insurance
• Paid public transit
• Beautiful office space in Montreal’s Old Port
• Onsite yoga and healthy snacks
• A strong team and culture committed to learning and high performance

Contact Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting SD0329” in the subject line – we are looking forward to hearing from you!

35Pharma is a fast growing, values-driven biotechnology company based in Montreal, Canada, currently looking for a highly motivated and pro-active Translational Scientist who will join our growing team in our mission to develop medicines that radically transform patients’ lives.

In close collaboration with your discovery and clinical colleagues, you will be in charge of designing, executing and analysing mode of action studies for our pre-clinical drug candidates as well as developing plans for pharmacodynamic assessment of clinical samples.

This is an opportunity to play an integral part in progressing drug candidates through the pre-clinical stage towards patients worldwide. The position would be an excellent fit for early career professionals looking to gain knowledge within the field of pharmaceutical biotechnology or experienced professionals ready to take on a leadership role within translational research.

You will love this job if:

• You have a passion for science and drug development
• You thrive in a fast-paced environment with lots of responsibility and opportunity to learn
• You are a self-starter who enjoys working as a team player and value good communication

Key Responsibilities:

• Plan, lead, facilitate and coordinate pre-clinical mode of action studies using internal and external resources
• Contribute to establishing PK/PD models for our drug candidates
• Lead the drafting and updating of regulatory and clinical documents as they pertain to pharmacodynamic assessments
• Support target discovery and validation
• Analyze data, prepare presentations and reports and present to colleagues and management
• Work closely with members of other departments to ensure that a coordinated effort can be made to rapidly advance new projects to the clinic
• Train and coordinate the activities of the research associates to achieve the company’s objectives

The successful candidate will exhibit the following minimum profile:

• Life Science PhD (Biology, Pharmacology, Medicine, Biochemistry etc
• Strong background in proteomic and gene expression assessments such as ELISA, qPCR, RNAseq, mass spectrometry etc
• Broad experience with histopathology methods
• Familiarity with procedures of animal experiments
• Flexible, independent and self-motivated, able to handle multiple tasks and priorities, ability to adapt
• Highly meticulous with excellent attention to detail
• Excellent written and verbal communication skills (French and English). (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate)
• An unwavering commitment to the highest quality of work, research ethics and willingness to learn

Any of these qualifications in addition would be a huge plus:

• Documented industry experience and successful track record, particularly within PK/PD assessments or biomarker discovery
• Significant experience with computational methods such as handling big proteomic or gene expression datasets, image analysis, GWAS or similar
• Experience with clinical trials in an industry or academic setting
• Background in cardiopulmonary or cardiometabolic diseases

Perks:

• Generous private health insurance
• Paid public transit
• Beautiful office space in Montreal’s Old Port
• Onsite yoga and healthy snacks
• A strong team and culture committed to learning and high performance

Contact

Please send your CV and cover letter outlining your motivation and relevant experience for the role to careers@35pharma.com quoting “35Pharma Posting STR0329” in the subject line – we are looking forward to hearing from you!

Role:

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

The Analytical Development Scientist will be responsible for the planning / development / implementation / optimization of assays necessary for assessing protein characteristics. The incumbent will participate in the assessment of the quality of manufactured lots using platform tests and support R&D activities. Additional responsibilities will be to plan and execute the pre-validation of developed assays using defined scientific and regulatory practices required for assay transfer to QC laboratories. An important part of the role will be to structure data analysis, perform the trending of data, and to write and/or review analytical documentation (analytical development reports, analytical methods, work instructions for the use of laboratory equipment, etc.). The incumbent will also organize and execute the development of appropriate formulations to ensure stability and suitability for clinical administration of a drug product.

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

Duties and Responsibilities:

• Design the development or implementation of analytical assays for protein-based compounds.
• Lead the development of robust analytical procedures adapted to manufactured proteins assay panel.
• Use scientific knowledge and field established best practices in use for product analytical characterization.
• Provide scientific support and guidance during assay development and product characterization.
• Participate in the assay transfer, qualification or validation as per ICH guideline to QC laboratories.
• Perform structured data analysis, trending and basic statistics.
• Generate internal protocols, reports and procedures.

Qualifications :

• At a minimum a graduate level (M.Sc.) in biochemistry, biotechnology, life sciences or equivalent.
• At least 3 years of experience in analytical development or relevant experience in the biopharmaceutical or biotechnology industry.
• Experienced in protein chemistry and related analytical methods.
• Hands on experience with HPLC and/or Capillary Electrophoresis (CE), Dynamic Light Scattering (DLS) and/or immunological techniques (ELISA).
• Experienced in experimental planning, problem solving and troubleshooting.
• Demonstrated structured analytical thinking, precision and attention to details.
• Ability to execute experiments independently and efficiently.
• Ability to work in cross-functional teams and in a fast-paced environment.
• Experience of the current Good Manufacturing Practices (cGMP) is an asset.
• Excellent written and verbal communication skills (French and English). (This position involves daily collaboration with suppliers, teams and partners located outside of Quebec, requiring a strong knowledge of English by the candidate).

Key words: Biochemistry, Protein Analyses, Assay Development, HPLC, Capillary Electrophoresis, ELISA, DLS

Role:

The role of the research associate is to participate in the development of manufacturing processes for the expression and/or purification of therapeutic recombinant proteins. Processes are developed as part of scaling up and manufacturing according to Good Manufacturing Practices (GMP). Another important part of this role is the rapid production of recombinant proteins using the company’s laboratory platform for the selection of candidate proteins. The incumbent will use defined scientific practices to develop and/or use protein production procedures to support technology transfer to contract manufacturing organizations. Other responsibilities include participating in the maintenance of laboratory equipment and the evaluation of data trends.

This is a full-time position reporting to the Associate Director of Process Development and is based in Montreal, QC, Canada.

Functions and responsibilities:

• Produce recombinant candidate proteins from the CHO/HEK-293 cell line system platform using shaker flasks, bioreactors (WAVE), clarification, filtration, chromatography (e.g.: affinity, ion exchange, hydrophobic interaction) and formulation (tangential flow filtration) techniques, among others.
• Perform mammalian cell culture activities such as cell maintenance, transfection for transient expression as well as preparation of stable expression pools using CHO cell lines.
• Participate in the development of robust manufacturing processes (upstream and/or downstream) on candidate recombinant proteins.
• Perform routine analyses (CE-SDS, SDS-PAGE, ELISA, HPLC).
• Responsible for the analysis and documentation of experimental data (electronic laboratory notebook and files).
• Prepare protocols and reports on experiments performed.
• Responsible for the maintenance of laboratory equipment.
• Provide technical and scientific support during the development process.
• Participate in technology transfer activities.
• Use a quality-by-design (QbD) approach during all process development phases.

Qualifications:

• At least a Bachelor of Science (B.Sc.) degree in biochemistry, biotechnology, life sciences or equivalent.
• A minimum of 2 years of experience in process development and/or manufacture of recombinant proteins or relevant experience in biotechnology or biopharmaceutical industry.
• Experience in purification of recombinant proteins (chromatography, TFF)
• Experience in mammalian cell culture and recombinant protein expression systems.
• Meticulous laboratory practice with good aseptic technique.
• Knowledge of downstream process technologies and protein purification.
• Ability to conduct experiments independently.
• Ability to work in multifunctional teams and in a dynamic environment.
• Experience in problem solving.
• Knowledge of Good Manufacturing Practice (GMP) is an asset.
• Effective communicator in writing and speaking.

Key Issues: Biochemistry, Process development, Chromatography, Recombinant Proteins expression