Consultant

Description

We are offering a long term contract employment opportunity for a Consultant in the Pharmaceutical industry, based in Warren, New Jersey. This role involves substantial interaction with both small and large molecule clinical and preclinical development projects, with a focus on maintaining scientific quality and adhering to regulatory guidelines.

Responsibilities:
Execute quantitative analysis of biological samples as part of our development projects
Develop, validate, and conduct bioanalytical assays in a regulated environment
Uphold the scientific integrity of bioanalytical projects associated with clinical and preclinical development
Adhere to all safety guidelines and regulatory standards in all tasks
Contribute to the creation of analytical reports when necessary
Ensure compliance with Good Laboratory Practices (GLP) and Good Documentation Practices (GDP)
Maintain a comprehensive and detailed laboratory notebook
Handle additional tasks and assignments as directed by management
Utilize laboratory equipment and techniques effectively, including ELISA and Assay Analysis
Leverage experience in Laboratory Information Systems to streamline processes.

Requirements

KNOWLEDGE/SKILLS/ABILITIES REQUIRED

* Minimum level of education and years of relevant work experience.

• PhD in biology, chemistry, biochemistry, pharmaceutical science, pharmacology, or other related scientific discipline or Master's degree in these same disciplines with a minimum of 3 years of experience or Bachelor's degree in these same disciplines with a minimum of 5 years of experience and progressively responsible experience in regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.).

* Special knowledge or skills needed and/or licenses or certificates required.

• Demonstrated experience applying analytical techniques to the regulated bioanalysis of clinical / preclinical samples (plasma, urine, cells etc.) using LC-MS/MS, quantitative PCR (qPCR), ELISA, Mesoscale Discovery (MSD) and flow cytometry techniques.
• Applied understanding and knowledge of bioanalytical method validation guidelines governed by FDA or other global health authorities.
• Demonstrated ability to work on complex problems to produce experimental data across one or more projects.
• Demonstrated technical proficiency, scientific creativity, the ability to collaborate with others and the ability to think independently within a fast-paced, matrixed, team environment consisting of internal and external team members.
• Possesses detailed and expert knowledge of scientific principles and concepts.
• Demonstrated ability to work effectively in a multi-disciplinary team environment.
• Proficiency with Microsoft Office. particularly MS Excel and MS PowerPoint.
• Excellent verbal and written communication and skills.
• Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
• Demonstrates an understanding of the strategic alignment of his/her work with corporate goal(s) and demonstrates the ability to adapt to changing priorities and deadlines.
• Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

*Special knowledge or skills and/or licenses or certificates preferred.

• Experience in writing analytical reports, laboratory operating procedures and work instructions.
• Experience in working within or with a Contract Research Organization (CRO).

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All applicants applying for U.S. job openings must be legally authorized to work in the United States. Benefits are available to contract/temporary professionals, including medical, vision, dental, and life and disability insurance. Hired contract/temporary professionals are also eligible to enroll in our company 401(k) plan. Visit roberthalf.gobenefits.net for more information.

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