Job Title: Scientific Associate - Fetal Path
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.
Perform fetal soft tissue and skeletal evaluations. Provide scientific support for nonclinical research or laboratory based studies; perform basic to complex study management tasks and interpretation and reporting of study data/conclusions.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Prepare and evaluate fetal soft tissue and skeletal specimens as required according to Standard Operating Procedures (SOPs), including writing edits, taking photographs, answering internal and external audits and drafting computer protocol requests.
- Oversee study start-up procedures requiring cross-departmental interaction with all key study personnel.
- Assist in generating study protocols and laboratory-based procedures for various regulatory guidelines.
- Ensure that all fetal soft tissue and skeletal data for the studies are accurately recorded and verified.
- Ensure that all adverse fetal observations are confirmed according to SOPs.
- Review, interpret, integrate, and present basic to complex data on assigned studies, with limited assistance from departmental scientific staff.
- With minimal guidance from senior scientific staff, function as an Individual Scientist/Principal investigator on assigned studies of basic complexity and participate in method development and validation activities.
- Ensure project is in compliance with GLP regulations as they apply to the conduct of nonclinical research.
- Prepare reagents (KOH, etc) for fetal processing.
- Provide leadership and technical guidance and serve as a mentor to less experienced staff.
- Collaborate with scientific and technical staff to develop new techniques and/or models.
- Contribute to department operations improvement in areas such as process development, SOP revisions, department inspections, and equipment maintenance.
- Provide updates of the fetal evaluation schedule to ensure internal/reporting milestones are met.
- Ensure adequate supplies of all equipment/materials needed for fetal evaluation.
- Pack and archive fetal soft tissue and skeletal specimens according to SOPs.
- Train laboratory personnel in preparation and evaluation of fetal soft tissue and skeletal specimens, including data entry.
- Attend scientific meetings, conferences, and training courses to enhance job and professional skills.
- Perform other duties as assigned.
- Education: Bachelor’s degree in a scientific discipline or equivalent, including coursework in anatomy and biology.
- Experience: 6 to 10 years related experience in fetal morphological assessments including 5 years related experience in contract research or pharmaceutical industry.
- An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.
- Certification/Licensure: Fetal Pathology certification preferred.
- Other: None.
- General office working conditions.
- The noise level in the work environment is usually quiet.
- May occasionally be exposed to fumes or airborne particles, unpleasant odors, and/or wet, humid and/or extreme temperature conditions.
- While performing the duties of this job the employee may occasionally be required to wear protective clothing (goggles, face shield, surgical mask, cap, gloves, scrubs, boots), work near toxic or caustic chemicals, work with biohazards, and/or work with live animals with risk of exposure to allergens and/or zoonotic diseases.
- This position requires occasional domestic travel.
- This position may require occasional weekend and holiday work.
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