LC-MS Method Development Scientist

Altasciences

$80K — $95K *
Pharmaceuticals & Biotech
Less than 5 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's or higher degree in Chemistry, Biochemistry, Immunology or related field.
  • 3 years experience in regulated clinical/preclinical studies preferred.
  • 1 year experience as Scientist or equivalent role.
  • Knowledge of regulatory guidelines and GLP regulations.
  • Strong organizational and troubleshooting skills.

Responsibilities

  • Develop, plan, manage, and conduct multiple assay types for scientific quality.
  • Act as the Bioanalytical Principal Investigator for validation and sample analysis.
  • Manage projects, ensuring materials are ordered as needed.
  • Provide QC support and review data batch for assigned studies.
  • Mentor team members, assisting with sample analysis and validation studies.

Benefits

  • Health/Dental/Vision Insurance Plans
  • 401(k)/RRSP with Employer Match
  • Paid Vacation and Holidays
  • Paid Sick and Bereavement Leave
  • Employee Assistance & Telehealth Programs
  • Telework options when applicable
  • Training & Development Programs
  • Employee Referral Bonus Program
  • Annual Performance Review
Full Job Description

About The Role
The Scientist, LCMS is assigned to projects based on scientific competency and training. The Scientist will ensure the overall integrity/quality of assigned studies. The Scientist can also be designated as the main contact for client interactions laboratory for their assigned projects.


What You'll Do Here

  • Autonomous and proficient developing, planning, managing, conducting, reporting and troubleshooting multiple assay types to ensure scientific quality, regulatory expectations, and client satisfaction

  • Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).

  • For validations and sample analysis the Scientist can be assigned as Bioanalytical Principal Investigator and is the first point of contact for PM and/or clients for laboratory services and will manage and conduct method development, qualification , validation and production studies for clinical and non-clinical studies in compliance with the protocol/study plan, amendments, GCP, GLPs, SOPs and Best Practices;

  • Manage project and order appropriate material, as needed

  • When applicable, provide QC support on studies assigned to other team members in laboratory based on training and competencies.

  • When applicable, perform data batch review, perform multi-batch trend analysis, complete documentation as required by tracking deviations, events and reports of non-compliance and review or approved Memo to File or SOP/Protocol/Study Plan deviations;

  • When applicable, provide a report and/or reporting of results, within study timelines and ensure any deviations/exception events are reflected as appropriate and assure that all analysis conducted is reported and is accurate;

  • Manage as to maintain timeline and scheduling commitments

  • When applicable review and provide comments and recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document, as needed;

  • Support and mentor Analysts in the daily operations for completion of sample analysis and/or validation studies and the analysts work;

  • Support and mentor other team members based on expertise,

  • Responsible for troubleshooting issues within the studies and be able to resolve them independently via development of appropriate procedure.

  • Organize and communicate complex data sets in a clear and concise manner to key stakeholders from diverse backgrounds

  • To write, review and updated method SOP as needed

  • Participate in meetings with clients, conferences and scientific outreach

  • Conduct applicable work in compliance with applicable SOPs, GCPs, GLPs, and observe all company guidelines and policies

  • Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures;


What You'll Need to Succeed

  • Ideally College degree and/or University degree in Chemistry, Biochemistry, Immunology or applicable field.

  • Preferred experience in regulated clinical and/or preclinical studies with typically 3 years of experience.

  • Minimal 1 year experience as Scientist or equivalent.

  • Knowledge of regulatory agency guidelines, must understand general SOPs and have excellent knowledge of GLP regulations.

  • Good organizational skill, highly flexible.

  • Sense of urgency.

  • Excellent troubleshooting skills.

  • Client oriented, attentive to details.

  • Be able to easily read and understand study plans and protocols and ability to coach/mentor people.

  • Good communication both written and verbal in French & English.

  • Must deeply understand general SOPs and have an excellent knowledge of GCP/GLP regulations.

What We Offer

Altasciences offers a wide variety of benefits to help our employees live healthy and fulfilling lives both at and outside of work.

Altasciences’ Benefits Package Includes

  • Health/Dental/Vision Insurance Plans

  • 401(k)/RRSP with Employer Match

  • Paid Vacation and Holidays

  • Paid Sick and Bereavement Leave

  • Employee Assistance & Telehealth Programs

  • Telework when applicable

Altasciences’ Incentive Programs Include:

  • Training & Development Programs

  • Employee Referral Bonus Program

  • Annual Performance Review

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