Associate Director, Method Development Bioanalytical Chemistry

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, well help you build a career that you can feel passionate about.

Job Summary

The Associate Scientific Director (ASD) in Bioanalytical Chemistry oversees the scientific conduct of all projects/programs within the group. The role includes oversight of the method development activities and discovery programs. It involves leading strategic initiates for the purpose of growth in services, staff development, and promoting external scientific visibility. The ASD is directly involved in and/or directing scientific mentoring and coaching across the group. Lastly, the ASD is a key participant in achieving revenue target goals and in building and retaining sponsor relationships. In all cases the Associate Scientific Director works within the expectations for proper study conduct as determined by SOPs and the SD/Pl/Management.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

Support and build upon the overall technical strength in the bioanalytical group by providing input and guidance on approach, conducting background research, doing feasibility, and drawing on a depth of personal expertise.

Lead the method development and discovery services groups

Ensure methods from the method development are fit-for-purpose, and ready for FDA/EMA validation guidelines (where appropriate).

Ensure on-time and quality delivery for non-GLP/discovery study support

Coach and mentor, the development of staff in these groups for continued technical growth

Direct the development of novel scientific approaches, including providing creative input on developing new assay platforms and service offerings.

Contribute to a scientific strategy that includes external visibility at conferences, including poster, podium talks, and publications

In concert with the Director, contribute to the overall bioanalytical day-to-day activities, i.e. reviewing program and project data, providing regulatory guidance, and general support for junior staff, as appropriate and required.

Contribute to the proposal/bidding process and wining new sponsors/work

Directly work with sponsors providing project updates, overviews, and guidance

Contribute to the development of department plans and long-term goals/vision (i.e. growth plans, revenue goals, process improvements, new software/instrument infrastructure)

Coach and mentor across all bioanalytical staff to increase the technical proficiency of the group

Present and/or contribute to presentations, scientific and operational, to internal and external WIL groups

Routinely serve as a lead representative of the bioanalytical department, internally and externally

Review and sign as management on reports, deviations, etc.

Contribute SOP and compliance infrastructure, as appropriate

Job Qualifications

Education: Bachelors degree (B.A./B.S.) or equivalent in a scientific related discipline preferred. Masters Degree in, chemistry or a related scientific discipline recommended. Ph.D. preferred.

Experience: 5 years relevant laboratory experience in a contract research organization (CRO), biotechnology, or pharmaceutical environment, working to Good Laboratory Practice (GLP) standards. 3 years management experience, including staff management and development, and financial responsibility including budgets.

Certification/Licensure: None.

Other: Understanding PK/TK and metabolic processes

Significant depth of knowledge in regulatory compliance (FDA/EMA/EPA) as relates to bioanalytical sciences

PHYSICAL DEMANDS:

Must be able to lift, move, manipulate and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.

Must be able to perform procedures, standing or sitting, for long periods of time, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.

Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.

Must be able to regularly provide information to and receive information from/through various technologies, media, sources, and contacts. Must be able to accurately exchange information in these situations.

Regularly operates a computer and other office productivity machinery, such as a calculator, copy machine, and computer printer.

Move about inside the work area to access file cabinets, office machinery, etc.

Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

WORK ENVIRONMENT:

General office and lab working conditions, the noise level in the work environment is usually quiet.

While performing the duties of this job the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, work with biohazards.

The employee may occasionally be exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.

The employee may occasionally be exposed to fumes or airborne particles, unpleasant odors, and extreme temperature conditions.

The noise level in the work environment ranges from low to moderate depending upon the task being performed.

COMMENTS:

This position may require occasional travel.

Compensation Data

The pay range for this position is $130,000/yr. – $140,000/yr. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Competencies
Lead – We lead when we advocate our purpose and model our values, when we deliver innovation, when we embrace change, and when we appreciate and celebrate the great work of others.Care – We show we care when we respect each other, our animals and the communities where we work and live, when we create a positive healthy workplace, when we are mindful of our compliance standards, and when we choose to do the right thing.Collaborate -We collaborate when we partner with each other and promote teamwork, when we communicate clearly and effectively across the hall or around the globe, and when we welcome all forms of diversity and encourage inclusiveness.Own – We act like owners when we hold ourselves accountable for our actions, when we respond to internal and external client needs with speed and accuracy, when we set and achieve meaningful goals, and when we strive towards continuous improvement.

About Safety Assessment

Charles River is committed to helping our partners expedite their preclinical drug development with exceptional safety assessment services, state-of-the-art facilities and expert regulatory guidance. From individual specialty toxicology and IND enabling studies to tailored packages and total laboratory support, our deeply experienced team can design and execute programs that anticipate challenges and avoid roadblocks for a smooth, efficient journey to market. Each year approximately 300 investigational new drug (IND) programs are conducted in our Safety Assessment facilities.

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 Laboratories is an Equal Opportunity Employer – all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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 crrecruitmentUS@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.

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