Manager, Bioanalytical Sample Management

Title: Manager, Bioanalytical Sample Management

Location: Exton, PA

Reports to: Director, Sample Management and Lab Support

Full-time

Frontage Laboratories Inc. is an award winning, publicly listed (HKSE), full-service CRO/Contract Research Organization operating over 25 state-of-the-art laboratories across the US, Canada and China, and growing over 30% YOY. Our core competencies include drug metabolism, pharmacokinetics/ pharmacodynamics (PK/PD), safety and toxicology, bioanalytical services, chemistry and manufacturing controls for drug development, and core laboratory services for clinical trials.

Position/Job Summary:

The role of the Manager, Sample Management, entails supervising both the operational and personnel aspects of Bioanalytical Sample Management. This includes managing the entire lifecycle of biological samples and reference standards, encompassing their collection, processing, storage, tracking, and distribution. 

Roles & Responsibilities:

Operational Oversight

Maintain the day-to-day operations of the Bioanalytical Sample Management teams, including assigning, overseeing, and participating in the following tasks:

• Receive, log in, and meticulously track biological samples, reference standards, and chemicals in strict accordance with Standard Operating Procedures (SOPs).
• Maintain ongoing communication with clients and study sites, addressing any issues or concerns related to biological samples and reference standards.
• Ensure that biological samples and reference standards are stored under appropriate conditions to preserve their integrity.
• Prepare, track, and maintain all necessary documentation associated with biological samples and reference standards, following SOPs.
• Monitor and update sample storage status within freezers, and promptly notify clients and the finance team for accurate invoicing.
• Regularly prepare sample storage notification forms for clients.
• Communicate with clients regarding the disposal of samples, ensuring adherence to SOPs.
• Enter sample data into the Watson Laboratory Information Management System (LIMS).
• Register compounds in the E-Workbook.

Evaluate and optimize the existing workflow and perform risk mitigation.

Other duties as assigned.

Personnel Oversight

• Assigns and balances workload between sample management and individuals.
• Mentor and coach staff, facilitate training of new hires, participate in staff meetings and huddles.
• Responsible for personnel relations, including, but not limited, to hiring, annual reviews, promotions, and employee disciplinary actions.
• Works closely with Director, Sample Management and Lab Support, and Central Lab leadership to ensure employee engagement, department alignment and agility, and to establish and improve processes.

Quality Oversight

• Establish and maintain standard operating procedures.
• Enforce and adhere to safety and quality procedures.
• Oversee Quality Control processes in the Bioanalytical Sample Management team.
• Maintain knowledge regarding phase I-IV clinical trials, FDA regulations/ICH guidelines, and other pertinent regulations.

Education, Experience & Skills Required:

Bachelor’s degree or equivalent; at least 2 – 3 years’ experience in a clinical laboratory, research setting or CRO, 1 – 2 years’ of management experience required

• High level of accountability with self and others

• Hands-on approach with a desire to teach others

• Track record of challenging the status quo

• Team and action-oriented

• Problem-solving

• Priority setting

Frontage Laboratories Inc. is an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, among other things, or status as a qualified individual with disability.