Director, Operations

Microbial Solutions | Charles River; Shrewsbury; On-site; USD 176,000 - 230,000; Full time

Job summary

A leading company in safety assessment services seeks a manager for In-life Operations. The role encompasses financial management, personnel oversight, and ensuring compliance with regulatory standards. Ideal candidates will bring extensive experience in the pharmaceutical sector, particularly in research management and regulatory practices. You will contribute to improving study quality and operational efficiency in a dynamic team setting.

Benefits

401K

Paid time off

Health and wellness coverage

Employee and family wellbeing support programs

Work-life balance flexibility

Qualifications

• 8-10 years management experience in a research or pharmaceutical environment required.
• Experience in maintaining AAALAC International certification is required.
• Knowledge of GLP regulations and FDA guidelines is essential.

Responsibilities

• Manage In-life Operations and optimize resource utilization.
• Oversee budgeting, personnel management, and regulatory compliance.
• Collaborate with senior leadership to enhance service offerings.

Skills

Leadership

Communication

Organizational Skills

Negotiation Skills

Education

Bachelor’s degree in biological sciences

Master’s degree preferred

Job description

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 Summary

Responsible for the administration and management of In-life Operations, Formulations, Necropsy, Histology, Sample Processing, Clinical Pathology, Quality Control, Training and Archives. Responsible for the financial aspect, in collaboration with Finances and the Managerial staff, for the control of expenses to meet the company budget. Incumbent will optimize resource utilization to maintain an occupancy level to meet revenue targets. Collaborate with clients and scientific staff for effective study design, problem solving, and delivery of high-quality study data. Foster a culture of continuous improvement in site operations and ensure successful audits by regulatory agencies. Duties also include delegated activities as per the individual’s Delegation of Authority memo of Test Facility/Testing Facility Management Functions.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

• Develop short- and long-range operating objectives, organizational structure, staffing requirements and succession plans.
• Direct activities of assigned group(s) to ensure optimum performance of the group/function.
• Responsible for personnel management activities such as: scheduling, personnel actions (hiring, promotions, transfers, etc.), training and development, providing regular direction and feedback on performance, disciplinary actions and preparing and delivering annual performance and salary reviews.
• Integrate activities with those of other major organizational units (e.g. businesses, departments, functions).
• Develop and recommend departmental budget and authorize expenditures.
• Develop and oversee the implementation of departmental training programs, including orientation.
• Ensure adherence to pertinent regulatory requirements and to departmental policies, practices and procedures [SOPs, safety procedures and biosafety protocols].
• Represent the site to government, regulatory agencies, local, state and federal officials, industry groups, key customers as required.
• Work with senior leadership to identify new service offerings and/or business.
• Contribute to the development and presentation of major business proposals for key clients and represent the site and company.
• With the Managers and Supervisors, review processes to improve efficiency and efficacy, develop tools, strategies and plan of actions to meet budget, to meet our high-quality standards, to meet or exceed our capacity, to forecast the workload, to ensure that health and safety regulations, governmental regulations such as AAALAC, CCAC etc. are met.
• Responsible for identifying and implementing best practices across the groups, facilitating collaboration and resource sharing, and adherence to site, regional and global policies and initiatives.
  
  

The pay range for this position is between $$176,000 – $230,000. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.

Job Qualifications

Education: Bachelor’s degree (B.A./B.S.) or equivalent in biological sciences or related discipline recommend. Master’s degree preferred.

• Experience: 8-10 years related management experience in research or pharmaceutical environment required. Experience in maintaining AAALAC International, Inc. certification is required.
• An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
• Certification/Licensure: No specific certifications or licensure required
• Other: Knowledge of governmental regulations and guidelines applicable to the care and use of laboratory animals. Knowledge of GLP regulations and other FDA regulations applicable to non-clinical testing programs. Excellent organizational skills and the ability to meet deadlines. Excellent communication (both written and verbal), leadership and negotiation skills. Ability to interact appropriately with all levels of employees, while supporting the efforts of departmental teams.
  
  

About Safety AssessmentCharles 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 RiverCharles 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 [e-mail]. 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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