PK/ADA Scientist

Altasciences; Birmingham (AL); On-site; USD 85,000 - 120,000; Full time

Benefits offered by this job

Health Insurance

Dental Insurance

Vision Insurance

401(k) Plan

Vacation & Holidays

Sick & Bereavement Leave

EAP & Telehealth

Job summary

Altasciences in Birmingham, AL is seeking a PK/ADA Scientist II to drive multiple assay types with scientific rigor, ensure study integrity, and serve as the main client contact for laboratory services on assigned projects. You will lead method development, validation, sample analysis, data review and reporting within study timelines, and mentor analysts while coordinating with PMs and clients as needed.

Requirements include a college or university degree in Chemistry/Biochemistry/Immunology, 3+

Qualifications

• Bachelor or higher degree in Chemistry, Biochemistry, Immunology, or related field.
• Minimum 3 years of experience in a preclinical/CRO.
• Strong knowledge of GLP regulations and regulatory guidelines.
• Excellent organizational, problem-solving, and client-facing skills.

Responsibilities

• Develop, plan, manage, conduct, report and troubleshoot multiple assay types to ensure scientific quality and client satisfaction.
• Assigned by management on studies and tasks based on competency (may include method development, validation or analysis).
• Act as Bioanalytical Principal Investigator and main client contact for lab services and manage method development, qualification, validation and production studies.
• Manage projects and order appropriate materials as needed.
• Provide QC support and data review on studies and ensure deviations are tracked and reported.
• Write, review and update SOPs as needed; ensure timely reporting of results.
• Mentor Analysts and other team members to support daily operations.
• Ensure compliance with SOPs, GCP, GLP and health and safety guidelines.
• Organize and communicate complex data sets to stakeholders.

Skills

GLP/GCP knowledge

Preclinical CRO experience

Analytical troubleshooting

Project coordination

Mentoring

Education

Bachelor's degree in Chemistry, Biochemistry, Immunology or applicable field

Job description

About The Role

The PK/ADA Scientist II 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.

• Minimum 3 years of experience in a pre clinical/CRO

• 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.

Work Authorization & Sponsorship

Applicants must be legally authorized to work in the United States. Altasciences is unable to provide sponsorship, sponsorship transfers, or visa maintenance for this position. All applicants must possess valid work authorization that does not require employer sponsorship now or in the future.

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

Altasciences' Incentive Programs Include

• Training & Development Programs

• Employee Referral Bonus Program

• Annual Performance Review

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