Manager, Next Generation Sequencing

Job Overview

Provide operational management, technical support and professional and scientific expertise to the Next Generation Sequencing (NGS) department. Primary responsibilities include managing the day-to-day performance and execution of clients' studies and other related activities including overseeing resources availability.

Job Description

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Act as the technical expert for new and routine NGS assay applications and supporting resources
• Manage team of scientists/study managers/analysts and apply technical knowledge and skills to design, support and/or drive execution of experiments and client studies.
• Ensure proper training is evident for all laboratory personnel.
• Identify and assign laboratory personnel to conduct regulated activities supporting client studies.
• Responsible for compliance with global regulatory agencies guidance regulations and expectations
• Ensure testing is performed in accordance with applicable SOPs and regulations
• Maintain complete and comprehensive records for assay application/execution and study integrity
• Create and revise SOPs, laboratory records and other related documentation; write technical and testing reports as required
• Play an integral role in process improvement; promote a culture of continuous improvement and act as a champion for initiatives to drive quality improvement
• Provide technical/departmental guidance and support for internal and external interactions such as client and regulatory audits/inspections, meetings, and teleconferences
• Lead the NGS teams' projects that cross multiple disciplines in accordance with all standard operating procedures (SOPs) and regulations (cGxP).
• Liaise closely with the project management team and client representatives, as applicable, to ensure their expectations are met or exceeded.
• Liaise with internal and external stakeholders (clients) to manage deviations and other quality events and implement corrective actions as required for GMP laboratory testing
• Partner with laboratory operations and site shipping logistics to identify the possible need for a permit and permit requirements and support completion of necessary documentation to ensure applicable permits are obtained.
• Participate and/or drive assay development/assay transfer and/or assay validation activities; Ensure assays remain in a validated state within area of expertise
• Participate in critical event/lab investigations and liaise with support staff and management to ensure the significance of events is actively communicated to clients
• Represent the group during internal and external audits, client meetings and communications. Respond to audit observations, complaints and CAPAs
• Partner with site leadership to track all business metrics as they apply to the group and act when adverse trends or other issues arise
• Complete performance reviews fairly and on time; conduct regular one-on-one discussions with direct reports; interview and hire job candidates
• Provide support to sales team and quality assurance staff
• May perform other related duties as required and/or assigned

QUALIFICATIONS

• Masters in scientific or technical discipline with six (6) or more years relevant experience. An Equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Intermediate to advanced skills in applicable computer programs
• Ability to manage multiple high-complexity projects concurrently
• Strong experience with experimental design and GxP laboratory workflows
• Strong molecular biology skills, especially related to NGS
• Highly proficient in use of basic laboratory techniques, equipment, and materials
• Demonstrate a high degree leadership
• Effective coaching and training (or supervisory where relevant) skills for complex and highly technical work
• Demonstrate working knowledge of company commercial and financial strategies

Compensation Data

The pay rate for this role is $112,000 - $130,000 per year. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

About Biologics Testing Solutions
With more than 50 years of experience and proven regulatory expertise, the Charles River Biologics group can address challenging projects for biotechnology and pharmaceutical companies worldwide. Offering a variety of services such as contamination and impurity testing, protein characterization, bioassays, viral clearance studies and stability and lot release programs, we support clients throughout the biologic development cycle, from the establishment and characterization of cell banks through preclinical and clinical studies to marketed products. Whether clients need stand-alone services, a unique package of testing, or insourced support, our Biologics group can create a custom solution to suit their needs. Each year more than 20,000 biologic testing reports are sent each and over 200 licenses products are supported by our biologics testing solutions team.