Primary Purpose

This role provides scientific support to clients of Aliri Bioanalysis. Leading and directing scientific work to support projects and ensure regulatory requirements are met.

Job Duties and Responsibilities

· Able to lead and direct scientific work to support external methods and projects.

· Ensures client programs meet Aliri Bioanalysis, client, and regulatory requirements.

· Develops and reviews protocols and sample analysis plans.

· Reviews data with the method development team to ensure methods are ready for validation.

· Approves validation methods and reviews sample analysis methods.

· Independently reviews and approves raw data.

· Effectively evaluates data and tables to ensure regulatory guidelines and expectations are met.

· Reviews and approves reports for scientific accuracy and completeness.

· Provides technical support as needed.

· Assists with efforts to troubleshoot and solve assay problems.

· Recognizes the functions of different teams within Aliri Bioanalysis and seeks guidance when appropriate.

· Participates in scientific investigations.

· Approves QA project specific inspections.

· Approves data archival.

· Serves as the scientific point of contact for the client.

· Works with the client to determine project requirements.

· Gives scientific directives to the study team.

· Identifies scientific issues or scope changes within the study.

· Communicates and monitors scientific expectations with scientific staff and clients.

· Proactively identifies ways to increase client satisfaction.

· Promotes quality within the study team.

· Provides a technical resource for less experienced team members.

· Actively promotes collaboration within and across groups.

· Provides appropriate coaching and recognition to team members.

· Promotes a positive impression of Aliri Bioanalysis internally and within the industry.

· Able to plan, prioritize, and manage workload for large and complex projects.

· Demonstrated ability to manage high volume study work for key clients.

· Takes accountability and demonstrates responsibility regarding scientific study conduct.

· Good knowledge of client requirements.

· Manages time effectively.

· Performs other related duties as assigned

Qualifications, Skills, and Experience

Education

· Masters (MS) degree in science or related field

· Experience may be substituted for education

Experience

· 3-4 years of experience in the job discipline

Knowledge, Skills, and Abilities

· Excellent communication and interpersonal skills

· Proven ability to prioritize and manage time

· Excellent attention to detail

· Able to utilize word processing, database, spreadsheet, and specialized software

· Experience and skill with Watson, and Analyst preferred

· Knowledge of regulatory agency guidelines

Working Conditions

· May work with potentially hazardous substances and/or radio-labeled materials.

· May sit for extended periods of time.

· Limited lifting required (less than 25 lbs).

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Benefits offered to full-time Aliri Bioanalysis employees:

• Medical and Dental Insurance through Cigna
  • $3,000 Qualified High Deductible Health Plan with an employer HSA
  • $2,000 PPO Copay Plan, with choice of FSA
  • Dental PPO plan
• Vision insurance thorough VSP
• Life and disability through Mutual of Omaha
• Aliri Bioanalysis provides Basic Life & Accidental Death & Dismemberment (AD&D) insurance equal to 1x your annual earnings to a maximum of $300,000 in coverage
• Accident and Critical Illness plans through Mutual of Omaha
• Health savings and Flexible spending accounts through Rippling
• Additional Compensation incentive through our Bonus Plans for Full Time Employees.
• 401K through Voya-All Aliri Bioanalysis employees are eligible for the 401(k) immediately upon hire, if age 21 or older. Participation in the Plan will be effective after the first of the month following the date of employment and the first full pay period after the first of the month.
• As an additional perk of being an Aliri Bioanalysis employee, you’re eligible to receive a $60.00 reimbursement for a new or renewed Membership (Costco/Sam’s Club). You must be an employee of Aliri Bioanalysis at the time of reimbursement.

Aliri Bioanalysis provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.

This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.