Formulations Team Lead

Req ID #:  91132
Location: 

Morrisville, NC, US, 27560

For 70 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

We are seeking a Formulations Team Lead for our Discovery site located in Morrisville, NC.

BASIC SUMMARY:  
Responsible for providing oversight of formulation department to include receiving test articles, maintaining written and physical chain of custody of such, solubility evaluations. Provide leadership, technical guidance, and serve as a mentor to less experienced staff. May have supervisory responsibilities over less experienced team members. 
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  
•    Perform preparation of test article/substance dosage solutions/suspensions
•    Assign test and control material ID numbers.
•    Pack, inventory and organize return test materials and analytical samples to sponsor.
•    Assist in preparing responses to both internal and external quality assurance audits.
•    Assist in study start up procedures requiring cross departmental interaction with all key study personnel. 
•    Assist the department manager/supervisor and study technicians (in-vivo & in-vitro) in the execution of study-related activities required across all studies 
•    Promote inter- and intra-departmental communication in order to facilitate and maximize performance associated with research projects.
•    Prepare and record research data in compliance with Good Laboratory Practice Regulations (GLP), study protocols and Standard Operating Procedures (SOPs).
•    Work with scientific staff to develop new techniques and/or processes.
•    Contribute to department operations improvement in areas such as SOP revisions, department inspections, and equipment maintenance.  
•    Assist in rescheduling activities across studies as necessary to meet the needs of all ongoing studies.

•    Provide guidance in the day to day activities of assigned departmental employees to ensure accurate, high-quality work, and adherence to pertinent departmental policies, practices and procedures (SOPs, safety procedures and biosafety protocols).  Assist supervisor to prioritize workload of assigned group.  
•    Assist in the interview and selection of qualified non-exempt personnel.  Assist in developing recommendations regarding personnel actions, including hiring, promotions and raises.  Assist in the drafting of appropriate personnel action paperwork.
•    If relevant, identify training and development needs of assigned staff.  Assist in the development, implementation and delivery of departmental training programs; ensure that assigned staff receive departmental orientation and necessary on-the-job training.  May maintain group training manual and training records.
•    If relevant, monitor performance of assigned staff.  Assist in providing regular coaching and counseling.  
•    If relevant, schedule overtime as directed by supervisor.  Assist in the coordination of vacation/time off schedules.
•    Assist in the maintenance and communication of departmental systems and SOPs.  
•    Ensure that departmental equipment is maintained in good working condition and that departmental area(s) are maintained in a clean and orderly condition.  
•    Serve as a model as it relates to effective time management, communication and utilization of resources.  Provide leadership and motivation to departmental personnel.
•    Perform all other related duties as assigned.

Job Qualifications

Education:   Bachelor’s degree (B.A./B.S.) or equivalent in chemistry/pharmacy or related discipline.  
•    Experience:  2-4 years related experience in formulations or must have demonstrated effective performance at the previous level.  
•    An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
•    Certification:  None.
•    Other:  Demonstrated interpersonal skills, effective communication skills, and leadership/supervisory skills.  Proficient in technical skills and the operation of data collection equipment.  Knowledge of GLPs and other federal regulations and guidelines relating to formulations.  Understanding of routine and complex study design and protocols.  Knowledge of math to calculate and prepare dosing preparations/Formulations. 

About Discovery
Discovery from Charles River is industry-proven in the successful development of novel therapies, with over 320 patents and 74 preclinical drug candidates delivered to our sponsors in the past 17 years. Backed by more than 650 scientists, our comprehensive, integrated portfolio employs the latest technology and platforms to provide chemistry, biology, and pharmacology services that support clients from the earliest stages of hit identification all the way through to IND. Our client-focused, collaborative approach creates true partnerships that anticipate challenges, overcome obstacles, and move us forward together on the journey of getting new drugs to market.

 

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 17,000 employees within 90 facilities in 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. And in 2019, revenue increased to $2.62 billion.

 

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 supported the development of ~85% of the drugs approved by the FDA in 2019.

 

Equal Employment Opportunity

Charles River Laboratories is an Equal Opportunity Employer - M/F/Disabled/Vet.

 

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.
 


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