Formulations Specialist - Horsham, United States - Charles River Laboratories

Description

Formulations Specialist

Req ID #:

Location:

Horsham, PA, US, 19044

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, well help you build a career that you can feel passionate about.

**Job Summary**

Independently perform, prepare and/or oversee the preparation of vehicles and complex test article formulations for use in a variety of toxicology study designs. Assist in the accurate study preparation and oversight of formulation preparation procedures and ensure conduct according to Standard Operating Procedures and GLPs.

**ESSENTIAL DUTIES AND RESPONSIBILITIES:**

Copy Formulation Batch Records for routine studies and facility procedures.

Prepare Dispense definitions for routine studies and facility preparations.

Perform and/or oversee the preparation of test article/substance dosage solution/suspension(s), ensure preparation procedures and calculations are standardized, performed consistently and recorded correctly by the technical personnel.

Ensure accurate recording of test article and vehicles/reagents to maintain accountability and inventory. Monitor use on study and ensure accurate usage and inventory throughout the course of studies.

Calibrate, operate and maintain laboratory equipment.

Collect, record data and perform all tasks in accordance with Good Laboratory Practices Regulations (GLPs), study protocols and Standard Operating Procedures (SOPs).

Perform daily verification of formulation calculations and data quality control checks. Assists in ensuring correct test article calculations for studies, appropriate batch sizes are prepared and study supplies are monitored.

Perform review of study books and electronic data.

Interact with Study Directors, Study Coordinators, Data Management and other operational staff in the planning and conduct of studies.

Perform daily dispensary activities, meeting study timelines according to the daily schedule

Assist in overseeing client visits on assigned studies.

Prepare and/or review packing lists for the shipment of test articles and samples to the sponsor and/or analytical laboratory.

Ensure accurate inventory and management of test article and study reagents for assigned studies.

Independently respond to Quality Assurance audits of preparation procedures and facility audits and execute corrective actions

Conduct laboratory investigations into out of specification formulations.

Assist in training new personnel.

Recommend, participate and/or lead process improvement projects.

Perform other related duties as assigned.

**The pay range for this position is $32-$33 an hour. Please note that salaries vary within the range based on factors including, but not limited to, experience, skills, education, certifications, and location.**

**Job Qualifications**

**QUALIFICATIONS:**

Education: Bachelor degree (B.S.) preferred.

Experience: Minimum 4 years related laboratory experience required. Chemistry/Formulations experience strongly preferred.

An equivalent combination of education and experience may be accepted as a satisfactory substitute for the specific education and experience listed above.

Certification/Licensure: Must have valid, state-issued, drivers license.

Other: Must be detail-oriented and have good verbal and written communication skills. Must have good computer skills and experience with Microsoft Office software.

**PHYSICAL DEMANDS:**

Employees must be able to lift, move, manipulate, and/or hold heavy objects up to and including 50 pounds; this includes work materials, equipment, and/or supplies.

Must be able to perform procedures, which require, talking, hearing, standing or sitting for long periods of time, entering data into a computer, using appropriate instruments, reaching with hands and arms, working in narrow spaces, and wearing safety equipment (PPE) according to OSHA regulations and company standards.

Must be able to frequently hold and manipulate work materials while utilizing fine motor skills.

Specific vision abilities required by this job include close vision, color vision, depth perception, and the ability to adjust focus.

**WORK ENVIRONMENT:**

Works in a research environment, which requires use of sharp objects, working around mechanical parts, working with or near known or unknown toxic or caustic chemicals and/or biological hazards, exposure to fumes and airborne particles, working at noise levels ranging from moderate to loud.

While performing the duties of this job, the employee is regularly required to wear protective clothing (i.e., goggles, face shield, cap, gloves, scrubs, shoe covers), work near toxic or caustic chemicals, work with biohazards.

May occasionally be exposed to fumes or airborne particles, unpleasant odors and extreme temperature conditions.

The employee may be occasionally exposed to live animals with risk of exposure to allergens, zoonotic disease, and biohazards.

The noise level in the work environment ranges from low to moderate depending upon the task being performed.

**COMMENTS:**

This position requires overtime, weekend, holiday, and/or after hours shift coverage, as needed.

**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 300 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 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 clients 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 peoples 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 86% of the drugs approved by the FDA in 2021.

**Equal Employment Opportunity**

Charles River Laboratories is an Equal Opportunity Employer - all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, veteran or disability status.

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 [email protected] . This contact is for accommodation requests for individuals with disabilities only and cannot be used to inquire about the status of applications.

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