ACM Global Laboratories · 1 month ago
Manager, Research & Development
Headquarters, KY
Full-time
Onsite
Mid, Senior Level
$80K/yr - $120K/yr
7+ years expACM Global Laboratories is a leader in clinical trial laboratory operations, and they are seeking a Manager for their Research & Development department. The role involves managing R&D activities, coordinating with scientific leads, and ensuring compliance with regulatory requirements while overseeing client interactions and laboratory operations.
BiotechnologyInformation Technology
Responsibilities
Maintain daily departmental performance by managing resources, prioritizing tasks, and developing and monitoring metrics
Facilitate communication as a point of escalation or strategic point of contact for the department
Identify, lead, and/or participate in cross functional process improvement initiatives to optimize operational capabilities
Promote and uphold a high performing culture through effective talent planning, selection, onboarding and continuing education
Curate and deliver comprehensive training plans and materials to foster successful onboarding and employee performance
Provide ongoing coaching and mentorship supported by routine performance metrics to identify clear performance feedback and career development plans
Foster professional development through continuous coaching and performance management
Works with Principal Scientists and VP lab ops to support R&D and operations for strategic initiatives including new biomarkers and technologies
Creates plan for conference attendance and external marketing
Manage client programs and strategic initiatives in collaboration with the laboratory and other cross-functional departments
Assigns R&D team and supports team with Clients and 3PLs for oversight of haematology and chemistry and pharmacodynamic (PD) analysis
Coordinate and lead R&D team through the coordination of marketing material related to scientific strategy across all service lines and strategic initiatives
Accountable for design and execution of all clinical trials method validations in collaboration with operational teams and Principal Scientists
Ensures 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) NYSH / UK EMEA
Responsible for ensuring teams are trained and compliant with all regulations as appropriate
Manage and coordinate change control activities relating to technologies
Liaise with QA to complete internal and external audit findings
Coordinate trouble-shooting activities with laboratory operations and Principal Scientists
Coordinate and responsible for execution of scientific support of internal and external partners based on challenges and new technologies)
Oversee the harmonisation of global SOPs process as appropriate
Works with Principal Scientists and oversees 3PL relationships for R&D team
Coordinates the development of 3PL and Client strategy and attends meetings as appropriate
Ensures process of supporting pre award is effective and works with the Principal Scientists to suggest new testing requirements in line with client requests and the scientific strategy
Coordinates the translation of the analytical strategy into operational plans
Plans the initiation and oversees the execution of validations as appropriate
Oversees method onboarding activities in a suitable timeframe to support clinical trials activities as appropriate with support of Principal Scientists
Perform other duties as needed
Qualification
Required
BS in Life Sciences
7 years in Laboratory experience including 2 years of supervisory or leadership experience
Preferred
PhD in life sciences
Experience in Microsoft Office
EP Evaluator experience
Experience leading
Understanding of Good Clinical Practice (GCP), Good Laboratory Practice (GLP), Good Clinical Laboratory Practice (GCLP), College of American Pathologists (CAP), NYSH and UKEMEA
Application of science in a regulatory environment including validation of methodologies for clinical trials
Experience leading teams, projects, and troubleshooting strongly preferred
Company
ACM Global Laboratories
ACM Global Laboratories, an affiliate of Rochester Regional Health in Rochester, New York, is a recognized leader global clinical trial testing services.
1001-5000 employees
H1B Sponsorship
ACM Global Laboratories has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (1)
2024 (1)
2022 (1)
2021 (1)
2020 (1)
Funding
Current Stage
Late StageLeadership Team
Katie Sleeman
Sr. Human Resources Business Partner
Robert Diamond
Chief Information Officer
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