Formulations Specialist

Job Responsibilities:

• Coordinate vehicle and test article dose formulation preparation and verify standard operating procedures are followed. Escalate any preparation difficulties immediately to Study Director and Supervisor.
• Verify animal weights, infusion line lengths and test article purity to determine amount of material needed for dosing.
• Attend Pre-Study meeting with the Sponsor and Study Director to review and discuss preparation details and requirements.
• Confirm supply/reagent inventory meets protocol requirement, is a sufficient quantity and within date. Collaborate with Procurement for reagents and supplies with long lead time to ensure timely delivery.
• Perform calculation for protocol required chemical components and test article.
• Communicate effectively with all necessary personnel at the site (within department and outside the department) including weekends.
• Engage with clients by attending client meetings/calls and participating in on-site audits.
• Monitor and coach technicians on all aspects of study execution and ownership including preparation instructions, sample collection, and sample storage.
• Write the formulation procedure (Formulation batch record) and enter it electronically in Dispense to support various routes of administration including oral, intravenous, intramuscular, and subcutaneous.
• Review the study protocol to determine frequency and timing of dose preps, educate and mentor technicians on study execution requirements, communicate study amendments and adjust schedule, as needed.
• Review and perform QC of study data to mitigate protocol and/or SOP deviations.
• Define the level of difficulty needed to formulate various drug candidates into preclinical dosage forms.
• Perform the formulation development, compatibility assessment and daily activities in the Formulation department.
• Ensure equipment in the Formulation's laboratory is validated and calibrated.
• Conduct critical investigations, provide responses to client audits, perform root cause analysis and assist in providing corrective and preventative actions.

Minimum Requirements

Bachelor' degree in Biochemistry, Chemistry, or related discipline, or foreign degree equivalent, plus at least four (4) years of formulations or analytical laboratory experience.

The experience (which may be gained concurrently) must also include the following:

• 4 years of experience with electronic data systems for nonclinical studies such as Dispense and Provantis;
• 4 years of experience with the chemistry of solutions and suspensions, including concentration, weight, and volume measurements, density, and other aspects of weight to volume/weight preparations;
• 4 years of experience in utilizing laboratory equipment such as biosafety cabinet, glove bag, pH meter, osmometer, densitometer, water bath, sonicator, homogenizer and micropipette;
• 4 years of experience in regulatory awareness, including GLP and ALCOA principles;
• 3 years of experience in preclinical research and drug development process; and
• Advanced knowledge of Microsoft Office suite, predominately Outlook/Teams, Word, Excel and Smart Sheet.

Job Location: Charles River Laboratories, Inc., 905 Sheehy Drive, Horsham, PA 19044. (Telecommuting allowed 1 day per week). 40 hours per week, 6:30 am -- 3:00 pm.

To apply, send resume and letter of application detailing experience to Pauline Javorski, Associate Director, Human Resources, Charles River Laboratories, Inc., [email protected].