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Research Associate II Formulations 1

Req ID #:  43584
Location: 

Cleveland, OH, US, 44128

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.

 

 

We are seeking an experienced Research Associate IIfor our Safety Assessment site located in Cleveland, OH.

Under supervision of Manager of above, the Research Associate will be responsible for performing non-clinical safety testing studies and research studies in accordance with protocols, study timelines, operating procedures and productivity goals.  The Research Associate III is responsible for learning and adhering to federal regulatory guidelines and company standard operating procedures appropriate to the duties of the position, and is responsible for maintaining a professional, customer-service oriented approach towards both internal and external customers.

The Research Associate performs analytical method development, stability analysis and quantitative dose solution analysis in support of non-clinical safety testing studies and in accordance with general project plans, company standard operating procedures, applicable GLP regulations, timelines and company productivity standards.  Responsibilities include but are not limited to: analytical method validation, conduct of the analysis according to validated methods, documentation of deviations and amendments, data review/approval, investigation of out-of-specification results, accurate incorporation of results and conclusions into study reports prior to review by the study director.
 

ESSENTIAL DUTIES AND RESPONSIBILITIES:  

  • Perform non-clinical safety testing studies under the supervision of the assigned Study Director in accordance with general project plans, company standard operating procedures, applicable GLP regulations, timelines, and company productivity standards.
  • Review protocols prior to start of study to ensure the appropriate supplies and equipment are allocated, available and are operational.
  • Review future work plans with Manager or above to forecast workload and prioritize projects
  • Set-up, calibrate, and maintain electrophysiology equipment and associated supplies.
  • Solution preparation.
  • Record and maintain written and electronic data.
  • Submit laboratory and solution worksheets to quality assurance (QAU).
  • Develop working knowledge of company standard operating procedures and federal regulations applicable to duties and responsibilities.
  • Comply with company standard operating procedures and federal regulations (GLP, CMP, OSHA, etc.) as applicable to duties and responsibilities.
  • Initiate daily meetings with assigned Study Directors to review and approve study data.
  • Ensure data collection forms and solution worksheets are signed by the appropriate Study Director prior to submission to QAU.
  • Submit complete packet of signed laboratory notebook sheets and solution worksheets in chronological order according to study start and stop date to QAU.
  • Assist in maintaining equipment binders, including notifying Manager or above for repair or maintenance of equipment, documenting routine maintenance.
  • Provide timely reports on work product, as needed (e.g., study results, productivity, etc.)
  • Assist in routine clean-up and maintenance of the general laboratory facility.
  • Participate in scientific journal clubs, including reviewing, critiquing, and presenting articles.
  • Attend weekly scientific staff meetings and mandatory company operational and training meetings.
  • Perform all other related duties as assigned.

 

QUALIFICATIONS:

  • Education: Bachelor’s degree in biology, chemistry, or related scientific related discipline.
  • Experience: Minimum 3-5 years of industry experience.
  • An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
  • Certification/Licensure: Certification as appropriate for specialty preferred.

Other: Ability to work in team environment and manage multiple projects to meet predetermined deadlines. Ability to demonstrate initiative by independently identifying, investigating, and developing solutions to problems.

 

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 11,000 employees within 70 facilities in 18 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 2016, revenue increased by 23.3% to $1.68 billion from $1.36 billion in 2015.

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 ~70% of the drugs approved by the FDA in 2016.

For more information, please visit www.criver.com.


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


Nearest Major Market: Cleveland

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