Director Biologics Testing
Wayne, PA, US, 19087
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
Responsible for providing leadership, oversight and management of assigned groups and/or site(s). Partner with site leadership to ensure achievement of performance goals, including identifying and developing staff and active succession planning. Serve as a partner and liaison between site operational leadership and biologics sales teams to assess new business opportunities and assess skill gaps that maybe required for technological growth.. Direct the conduct and quality of all aspects of operations, activities and/or projects within areas of responsibility.
Job Description
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Provide oversight and management of assigned groups and site(s) so they are strategically aligned between areas of responsibility and site(s) and corporate strategic plans and short and long term plans.
- Serve as a liaison between Sales and Operations to assess new business opportunities.
- Analyze business financials internal to the PA Biologics sites and partner with Leadership and Sales to identify opportunities and strategy.
- Foster effective communication between departments and site(s).
- Identify problems and propose effective solutions for resolving operational issues.
- Oversee the development, implementation, and management of programs that will ensure efficiency and will maximize all applicable resources.
- Develop and lead a program of ongoing improvement for all assigned groups and/or site(s).
- Contribute to the development and implementation of organizational structures and processes that facilitate rapid growth and allow staff to utilize their full personal capabilities and contribute fully to the successful functioning of the organization.
- Responsible for ensuring adherence to established performance metrics (e.g., on time reporting, overtime, turn over and other efficiency metrics)
- Responsible for setting goals (and managing performance against established goals) for staff that are aligned to site, business unit and overall CRL values and goals
- Resolve internal and external customer requests, inquiries, and complaints and provide technical assistance.
- Ensure compliance, follow through, and work to resolve issues that directly impact compliance.
- Ensure all laboratory operations and assays are maintained in a state of current industry standard validation, including revalidation when necessary to meet regulatory expectations.
- Direct activities of assigned group(s) to ensure optimum performance of the group/function.
- Ensure respective departments operate in full compliance with domestic and foreign cGMP guidelines and appropriate federal, state, and local regulatory requirements.
- Assist the Site Director with regular staffing and budgetary matters, and with related special projects.
- 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.
- Develop and recommend departmental budget and authorize expenditures.
- Develop and oversee the implementation of departmental training programs, including orientation.
- Oversee the development of a departmental plan for backup and succession of key departmental personnel.
- Ensure adherence to pertinent local, national and international regulatory requirements (e.g. FDA, EMA, MHW) and to departmental policies, practices and procedures [SOPs, safety procedures and bio-safety protocols].
- Perform all other related duties as assigned.
QUALIFICATIONS:
- Education: Bachelor's degree (B.A./B.S.) or equivalent or higher in life sciences or related discipline. Master's degree preferred.
- Experience: 10 or more years of experience in the biotechnology, pharmaceutical or Contract Research industry. Strong background in a scientific discipline relevant to biologics testing such as molecular biology, virology, microbiology or analytical biochemistry. 5 or more years related management experience. Experience in a cGMP environment.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
Compensation Data
The pay rate for this role is $175,000 - $190,000 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.
Nearest Major Market: Philadelphia
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