Job Description
Our Company is a leading global biopharmaceutical company with a 125-year history of Inventing for Life with an inspiring mission to make discoveries that positively impact global healthcare. Our success is driven by putting patients first, operating with the highest integrity, and committing fully to our vision to make a difference in the lives of people globally. With our diverse pipeline of vaccines, biologics, small molecules, and newer modalities, we are at the forefront of research to advance the prevention and treatment of diseases such as COVID-19, cancer, cardiometabolic diseases, Alzheimer's disease and infectious diseases including HIV, and Ebola.
The Nonclinical Drug Safety (NDS) group at the West Point, PA site is seeking a highly motivated individual with strong technical and communication skills and attention to detail to join the Central Pharmacy laboratory within the Toxicological Sciences group. Central Pharmacy is responsible for the preparation of vehicle and test article dosing formulations to support Good Laboratory Practices (GLP)-compliant and exploratory non-clinical studies. Additional study support activities include maintaining documentation in an electronic document management system, coordinating collection of samples of dosing formulations for analysis, authoring the test and control article information section of study reports, and receiving and shipping materials to support internal and Contract Research Organization studies. Chemists also maintain the pharmacy's test and control article, chemical, GLP reserve sample, and controlled substance inventories.
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This position is for a 5 day/week work week, including coverage of weekends and holidays on a rotational basis.
Primary Responsibilities:
- Follow Standard Operating Procedures (SOPs), GLP's, and safety requirements.
- Perform tasks to execute assigned nonclinical studies.
- Collaborate with study stakeholders.
- Review and verify the test and control article section of the study protocol.
- Create dosing formulation preparation instructions to support various routes of administration including oral, intravenous, intramuscular, and subcutaneous.
- Perform accurate weighing of test and control articles.
- Prepare suspension and/or solution dose formulations daily or in bulk based on stability information using weight to weight or weight to volume techniques.
- Utilize standard formulation equipment such as a stir plate, water bath sonicator, pH meter, and homogenizer.
- Compile test and control article documentation needed to support the study.
- Author the test and control article sections of study reports.
- Apply sound basic laboratory skills that include observing, recording, and assessing data.
- Maintain accurate and highly detailed laboratory records.
- Work with several data acquisition computer systems/applications.
- Maintain laboratory functionality and inspection readiness by accurate maintenance of the CP inventory including compounds, lab supplies, and equipment.
Other responsibilities may include:
- Contribute to Central Pharmacy and cross-functional projects.
- Train and work cross-functionally in other areas within NDS and Preclinical Development.
Educational Minimum Requirements:
- BS/BA in Chemistry, Biology, or a related discipline with some relevant laboratory experience.
Required Experience and Skills:
- General laboratory experience (through academic coursework, internship, or an academic/position).
- Knowledge of the chemistry of solutions and suspensions, including concentration, weight, and volume measurements, density, and other aspects of weight to volume/weight preparations.
- Strong listening, communication (verbal and written), and collaboration skills.
- Ability to problem solve in a fast-paced environment and deliver results to meet timelines.
- Ability to work independently on assigned non-clinical studies and projects as well as being able to work in teams both within Central Pharmacy and cross departmentally, while adhering to the highest standards of trustworthy and ethical behavior in all interactions.
- Familiarity with recording and assessing laboratory data.
- Working knowledge of Microsoft Office suite, predominately Outlook/Teams, Word, Excel, and PowerPoint.
Preferred Experience and Skills:
- Experience in the pharmaceutical industry or biotech, or similar.
- Regulatory awareness, including GLP and ALCOA principles.
- Experience with electronic data capture for nonclinical studies.
- Basic knowledge of the drug development process.
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US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process.
We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit:
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We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
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U.S. Hybrid Work Model
Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
Search Firm Representatives Please Read Carefully
Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
Employee Status:
Regular
Relocation:
No relocation
VISA Sponsorship:
No
Travel Requirements:
No Travel Required
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
N/A
Job Posting End Date:
12/25/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.
Requisition ID:R326538