Manager, Next Generation Sequencing

For 75 years, Charles River employees have worked together to assist in the discovery, development and safe manufacture of new drug therapies. When you join our family, you will have a significant impact on the health and well-being of people across the globe. Whether your background is in life sciences, finance, IT, sales or another area, your skills will play an important role in the work we perform. In return, we’ll help you build a career that you can feel passionate about. 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.

About Charles River Charles River is an early-stage contract research organization (CRO). We have built upon our foundation of laboratory animal medicine and science to develop a diverse portfolio of discovery and safety assessment services, both Good Laboratory Practice (GLP) and non-GLP, to support clients from target identification through preclinical development. Charles River also provides a suite of products and services to support our clients’ clinical laboratory testing needs and manufacturing activities. Utilizing this broad portfolio of products and services enables our clients to create a more flexible drug development model, which reduces their costs, enhances their productivity and effectiveness to increase speed to market.

With over 20,000 employees within 110 facilities in over 20 countries around the globe, we are strategically positioned to coordinate worldwide resources and apply multidisciplinary perspectives in resolving our client’s unique challenges. Our client base includes global pharmaceutical companies, biotechnology companies, government agencies and hospitals and academic institutions around the world.

At Charles River, we are passionate about our role in improving the quality of people’s lives. Our mission, our excellent science and our strong sense of purpose guide us in all that we do, and we approach each day with the knowledge that our work helps to improve the health and well-being of many across the globe. We have proudly worked on 80% of the drugs approved by the U.S. Food and Drug Administration (FDA) in the past five years.

We’re committed to providing benefits that elevate your quality of life. Based on your position these may include: bonus/incentives based on performance, 401K, paid time off, stock purchase program, Health and wellness coverage, employee and family wellbeing support programs, and work life balance flexibility.

Equal Employment Opportunity

Charles River is an equal opportunity employer and is committed to providing equal employment opportunities for all qualified applicants and employees without regard to race, color, sex, religion, national origin, ancestry, age, mental or physical disability, family status, pregnancy, military or veteran status, or any other characteristic protected by federal, state, or local laws.

It is unlawful in some states (including Massachusetts) to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

If you are interested in applying to Charles River Laboratories and need special assistance or an accommodation due to a disability to complete any forms or to otherwise participate in the resume submission process, please contact a member of our Human Resources team by sending an e-mail message to crrecruitment_US@crl.com. This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

For more information, please visit www.criver.com.