LC-MS Method Development Scientist

Altasciences; Harleysville (PA); On-site; USD 70,000 - 95,000; Full time

Benefits offered by this job

Health/Dental/Vision Insurance Plans

401(k)/RRSP with Employer Match

Paid Vacation and Holidays

Paid Sick and Bereavement Leave

Employee Assistance & Telehealth

Telework when applicable

Job summary

Altasciences is seeking a Scientist, LCMS to lead analytical projects with autonomy, ensuring high quality data and regulatory compliance. You will handle method development, validation, and troubleshooting while mentoring analysts and communicating with clients.

The role requires a degree in a related field, 1+ year as Scientist, and strong knowledge of GLP/GCP guidelines. On-site work in Harleysville, PA, with opportunities for professional growth.

Qualifications

• Degree in Chemistry, Biochemistry, Immunology or related field.
• 3 years of regulated clinical/preclinical experience preferred.
• At least 1 year as Scientist or equivalent.

Responsibilities

• Develop, manage and execute multiple LCMS-based assays with quality and regulatory compliance.
• Serve as main client liaison for laboratory services on assigned projects.
• Lead method development, qualification, validation and production studies; ensure study plans and SOPs are followed.

Skills

Bioanalytical

Troubleshooting

Mentoring

Communication (FR/EN)

Education

Chemistry/Biochemistry/Immunology degree

Tools

LCMS instrumentation

SOPs & GLP/GCP knowledge

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