Associate Scientist, ADA, Immunogenicity

at  Altasciences

Laval, QC, Canada -

Start DateExpiry DateSalaryPosted OnExperienceSkillsTelecommuteSponsor Visa
Immediate19 Dec, 2024Not Specified23 Sep, 20243 year(s) or aboveGood communication skillsNoNo
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Description:

Your New Company!
At Altasciences we all move in unison to assist and work in the discovery, development, and manufacturing of new drug therapies to get them faster to people who need them. No matter your role, we all play an important part and you will have a significant impact on the health and well-being of people across the globe. By living our values of Employee Development, Customer Focus, Quality and Excellence, Respect and Integrity, we look to foster a passionate and collaborative work environment and we are looking for talented and enthusiastic people, like you, to join our growing team! Whether you’re a recent college graduate or seeking your next career opportunity, it’s time to discover your future at Altasciences.
We are better together and together We Are Altasciences.
About The Role
The Associate Scientist is the right hand help for the senior scientist. As such their responsibility is mainly to assist the senior scientist with tasks based on scientific competency and training. Based on competencies the Associate Scientist may be assigned as BPI.

What You’ll Do Here

  • Tabulate and perform final data batch review by performing multi-batch trend analysis, completing all study documentation as required including approving of Memo to File or SOP/Protocol/Study Plan deviations where appropriate.
  • Provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate.
  • Assist in writing validation and analytical plans/reports and provide comments and/or recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document.
  • Assist for planning sample analysis by maintaining timeline and scheduling commitments.
  • If assigned, perform the ordering of reagents, materials and if assigned verification of inventory. Perform literature searches and draft work plans for the development of assays as assigned.
  • Assist with evaluation of risk and costing. Based on training and competency, perform laboratory bench work for method development or validation, interpretation of results, documentation/tabulation of data and troubleshooting when required.
  • Keeps BPI and/or Senior Scientist involved through ongoing communications.
  • Write, review and update method SOP as needed Support responses to QA reports Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
  • Provide feedback on progress and assist in sponsor teleconferences as required.
  • Conduct all work in compliance with applicable SOPs, GCPs, GLPs and observes 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 year of experience.
  • Knowledge of regulatory agency guidelines and must understand general SOPs and have good 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, ability to coach/mentor people, good communication both writen 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 Reviews

LI-MB1

Responsibilities:

  • Tabulate and perform final data batch review by performing multi-batch trend analysis, completing all study documentation as required including approving of Memo to File or SOP/Protocol/Study Plan deviations where appropriate.
  • Provide report and/or final results within study timelines and ensure any deviation, exception or events are reflected as appropriate and assure that all analysis conducted are reported and accurate.
  • Assist in writing validation and analytical plans/reports and provide comments and/or recommendations, as needed, for the bioanalytical portions of preclinical and clinical protocols, study plans, laboratory manuals, Data Transfer Agreements, and/or other document.
  • Assist for planning sample analysis by maintaining timeline and scheduling commitments.
  • If assigned, perform the ordering of reagents, materials and if assigned verification of inventory. Perform literature searches and draft work plans for the development of assays as assigned.
  • Assist with evaluation of risk and costing. Based on training and competency, perform laboratory bench work for method development or validation, interpretation of results, documentation/tabulation of data and troubleshooting when required.
  • Keeps BPI and/or Senior Scientist involved through ongoing communications.
  • Write, review and update method SOP as needed Support responses to QA reports Assigned by management on studies and tasks based on scientific competency and training (can include method development, validation or sample analysis projects).
  • Provide feedback on progress and assist in sponsor teleconferences as required.
  • Conduct all work in compliance with applicable SOPs, GCPs, GLPs and observes all company guidelines and policies.
  • Respecting Health and Safety standards in terms of personal protection, laboratory maintenance, and work procedures


REQUIREMENT SUMMARY

Min:3.0Max:8.0 year(s)

Pharmaceuticals

Pharma / Biotech / Healthcare / Medical / R&D

Clinical Pharmacy

Graduate

Chemistry biochemistry immunology or applicable field

Proficient

1

Laval, QC, Canada