Team Leader Formulations

Req ID #:  48126
Location: 

Ashland, OH, US, 44805

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 Team Leader Formulations for our Safety Assessment site located in Ashland, OH.

Provides administrative, logistical and technical support for Scientific staff conducting studies or supporting functions for operations of the laboratory. Coordinates all laboratory support, pre-study activities, method development, method validation, study activities, data and/or reporting activities. Responsible for data review for completeness, quality or QC against the applicable protocol or procedure. May be responsible for drafting client correspondence, study correspondence, reporting or direct client interaction. Interacts with other departments, scientific staff, and sponsors either locally or across sites.

The following are minimum responsibilites related to the Team Leader Formulations position: 

  • Perform preparation of test article/substance dosage solutions/suspensions as required of advanced level formulation positions.
  • Assign test and control material ID numbers.
  • Organize, review, and QC data to be turned into Archives.
  • Perform taking reserve samples, retention samples and sub-samples as per protocol.
  • 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 the execution of all study-related activities required across all studies including the scheduling of daily work and technical staff.
  • Promote inter- and intra-departmental communication in order to facilitate and maximize performance associated with research projects.
  • Ensure that weekend assignments have been made, that the technicians assigned understand what needs to be completed, and that all assignments are covered.
  • Prepare and record research data in compliance with Good Laboratory Practice Regulations (GLP), study protocols and Standard Operating Procedures (SOPs).
  • Provide leadership, technical guidance, and serve as a mentor to less experienced staff.
  • Work with scientific staff to develop new techniques and/or models.
  • Contribute to department operations improvement in areas such as SOP revisions, department inspections and equipment maintenance.
  • Ensure raw data records are accurate, complete, and in appropriate order, and meet protocol specifications and/or GLP requirements.  Review documentation of functions performed as part of quality control requirements.  Review data as generated/collected by less experienced technical staff.
  • Use GLPs and SOPs processes and company policies when performing all job functions.
  • Assist in rescheduling activities across studies as necessary to meet the needs of all ongoing studies.

The following are minimum qualifications for the Team Leader Formulations position:

  • Education:   Associate’s degree (A.A./A.S.) or equivalent in chemistry/pharmacy or related discipline.  Bachelor’s degree (B.A./B.S.) preferred.
  • Experience:  4-6 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.

 

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 120 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 14,000 employees within 80 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 2018, revenue increased by 22% to $2.27 billion from $1.86 billion in 2017.

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 2018.

 

Equal Employment Opportunity 

 

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

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Nearest Major Market: Cleveland
Nearest Secondary Market: Mansfield

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