Principal Scientist
Rochester Regional Health

Job Info

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Description

HOW WE CARE FOR YOU:

ACM Global Laboratories, we are dedicated to getting health care right. Our robust benefits and total rewards foster employee wellbeing, professional development and personal growth. We care for your career while improving patients lives.

• Pension Plan
• Retirement Plan
• Comprehensive Benefits Package
• Tuition Reimbursement
• Benefits Effective Date of Hire
• Same Day Pay through Daily Pay
• Employee Referral Program
• Employee Assistance Program
• Employee Discounts
• Paid Time Off & Holidays

SUMMARY

As a part of Research & Development, the Principal Scientist will support testing, method development and validation. The Principal Scientist is required to keep up to date with new methods, applications and regulation while providing technical support at the bench, method validation and/or method improvement. The Principal Scientist will report to the Vice President of Clinical Lab Operations.

ACM Global Laboratories is a growing international organization that provides continued opportunities for internal advancement. At ACM you will be part of a team that is focused on improving people's lives where you are supported by leadership and colleagues. We are backed by a large healthcare network in the complex and rewarding field of advanced laboratory science. Your voice is heard, and with that, you have an ability to make an impact on the organization and influence your professional growth

STATUS: Full-time

LOCATION: Remote

DEPARTMENT: Research & Development

SCHEDULE: Days

ATTRIBUTES:

• PhD in related chemical, physical, or biological science field required.
• 5+ experience in Immunology & Chemistry or Hematology required.
• 8+ years' experience in a laboratory setting, including method validation and sample analysis and completion of an internal project which demonstrates research capability
  
• Experience in a regulatory environment, including Good Clinical Practice (GCP), Good Laboratory Practice (GLP) and/or Good Clinical Laboratory Practice (GCLP) preferred.

RESPONSIBILITIES:

• Method Development/Validation Facilitate assay development, conduct instrument validations and implement new testing to meet the needs of clinical trials protocols, clients and regulatory requirements. Independently lead method review and / or improvement. Responsible for assay/panel pre-validation, validation & correlation testing globally. Develop and validate highly complex or esoteric methods in a regulatory environment to support Clinical Trials, acting as a subject matter expert. Write and / or review bioanalytical reports for external clients as required. Collaborate with Research & Development, Scientific Affairs, and Laboratory staff in any way applicable to support Clinical Trials.
• Process Improvement & Quality Support Work with other functional areas to drive and implement improvements to quality standards and performance within ACM. Ensure ACM has a quality first attitude with respect to laboratory and scientific conduct.Ensure all methods and validations are done according to all applicable regulatory guidelines, including but not limited to Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), Medicines and Healthcare Products Regulatory Agency (MHRA), Food and Drug Administration (FDA), International Organization for Standardization (ISO), etc. May participate in internal/external client and regulatory audits.

EDUCATION:

• PhD (Required)

PHYSICAL REQUIREMENTS: S - Sedentary Work - Exerting up to 10 pounds of force occasionally Sedentary work involves sitting most of the time, but may involve walking or standing for brief periods of time. Jobs are sedentary if walking and standing are required only occasionally and all other sedentary criteria are met.

PAY RANGE: $115,000.00 - $130,000.00

The listed base pay range is a good faith representation of current potential base pay for successful applicants. It may be modified in the future. Pay is determined by factors including experience, relevant qualifications, specialty, internal equity, location, and contracts.

Rochester Regional Health is an Equal Opportunity / Affirmative Action Employer. Minority/Female/Disability/Veteran

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