WorkLlama, Inc.
We are seeking a highly motivated and experienced Senior Bioanalytical Scientist to join the Bioanalytical group within Global Preclinical Development, based in Rahway, New Jersey. The successful candidate will play a key role in developing, validating, and implementing ligand binding assays (LBA) under GLP conditions to support preclinical and clinical programs. This position requires strong technical expertise, independent problem-solving skills, and the ability to collaborate across multiple functional areas, including Drug Safety and Metabolism, Quality Assurance, and program management. The role involves laboratory work, method development, reporting, and interaction with internal and external partners. Travel between the Rahway, NJ and West Point, PA sites may be required.
Responsibilities
Independently develop, optimize, and troubleshoot LBA methods to support bioanalytical projects with a focus on quality and efficiency.
Implement ligand binding assays for biological sample analysis in a GLP environment, including sample preparation, instrument setup, data processing, and result interpretation.
Establish and maintain LBA capabilities within the team, including laboratory setup, workflow optimization, and equipment purchasing.
Ensure all documentation is completed accurately, in real time, and compliant with GLP and departmental guidelines.
Prepare and review bioanalytical reports (validation and sample analysis) and compile regulatory submission documentation.
Maintain compliance with company and departmental SOPs, GLP requirements, and safety standards.
Collaborate cross-functionally with partners across various internal departments.
Manage multiple projects and timelines independently while supporting team goals.
Perform additional bioanalytical assignments as directed by management.
Education
Ph.D. in Chemistry, Biochemistry, or related scientific discipline with a minimum of 3 years of industrial experience, preferably in a bioanalytical laboratory, OR
Master’s degree in Chemistry, Biochemistry, or related scientific discipline with a minimum of 7 years of industrial experience, preferably in a bioanalytical laboratory.
Experience Required
Proven experience developing, validating, and implementing ligand binding assays under GLP.
Excellent written and verbal communication skills.
Experience with Watson or other Laboratory Information Management Systems (LIMS).
Proficiency with Microsoft Office applications.
Preferred
Strong motivation and eagerness for continued learning and professional development.
Experience with LC-MS/MS assays.
Additional Information
Primary work location: Rahway, NJ
Travel: Up to 50% between Rahway, NJ and West Point, PA sites.
This role requires strong organizational, communication, and teamwork skills, along with the ability to work independently in a regulated environment.
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Responsibilities
Independently develop, optimize, and troubleshoot LBA methods to support bioanalytical projects with a focus on quality and efficiency.
Implement ligand binding assays for biological sample analysis in a GLP environment, including sample preparation, instrument setup, data processing, and result interpretation.
Establish and maintain LBA capabilities within the team, including laboratory setup, workflow optimization, and equipment purchasing.
Ensure all documentation is completed accurately, in real time, and compliant with GLP and departmental guidelines.
Prepare and review bioanalytical reports (validation and sample analysis) and compile regulatory submission documentation.
Maintain compliance with company and departmental SOPs, GLP requirements, and safety standards.
Collaborate cross-functionally with partners across various internal departments.
Manage multiple projects and timelines independently while supporting team goals.
Perform additional bioanalytical assignments as directed by management.
Education
Ph.D. in Chemistry, Biochemistry, or related scientific discipline with a minimum of 3 years of industrial experience, preferably in a bioanalytical laboratory, OR
Master’s degree in Chemistry, Biochemistry, or related scientific discipline with a minimum of 7 years of industrial experience, preferably in a bioanalytical laboratory.
Experience Required
Proven experience developing, validating, and implementing ligand binding assays under GLP.
Excellent written and verbal communication skills.
Experience with Watson or other Laboratory Information Management Systems (LIMS).
Proficiency with Microsoft Office applications.
Preferred
Strong motivation and eagerness for continued learning and professional development.
Experience with LC-MS/MS assays.
Additional Information
Primary work location: Rahway, NJ
Travel: Up to 50% between Rahway, NJ and West Point, PA sites.
This role requires strong organizational, communication, and teamwork skills, along with the ability to work independently in a regulated environment.
#J-18808-Ljbffr