Principal Scientist, Large Molecule Analytical Full-time

Principal Scientist

The Biologics Analytical Research & Development department of our Company's Research Laboratories Division is seeking applicants for a Principal Scientist position available at its Rahway, New Jersey research facility. The Principal Scientist is a highly visible and impactful senior scientific role tasked with working closely with the group Director to define analytical strategy and to lead a team of scientists in solving complex analytical problems at the interface of biology, chemistry, and lab informatics disciplines to enable development of biologics active pharmaceutical ingredients (APIs).

We are looking for a team player with strong leadership skills and the passion for mentoring and working along others in a laboratory setting. Applicants must have effective organizational and multi-tasking skills, have demonstrated excellent scientific leadership, and have superior communications skills, both written and oral. A track record of delivering impactful solutions to complex problems, and evidence of strong cross-functional collaboration is expected. Experience leading small groups of technical personnel, leading projects, and defining group or departmental strategy will aid in distinguishing candidates. An established reputation for scientific excellence supported by publications and external presentations is expected.

Qualifications

Education Minimum Requirements:

• Ph.D. in analytical chemistry/biochemistry or related field with a minimum of 8 years of experience in the pharmaceutical industry, M.S. in analytical chemistry/biochemistry or related field with a minimum of 10 years of experience in the pharmaceutical industry, or B.S. in analytical chemistry/biochemistry or related field with a minimum of 14 years of experience in the pharmaceutical industry.

Required Experience and Skills:

• Extensive experience in analysis of biologics (e.g., Size Exclusion Chromatography (SEC), Ion Exchange Chromatography (IEX) and Capillary Electrophoresis (CE) techniques
• Extensive experience with process- and impurity-related residual assay development using molecular biology and immunoassay techniques
• Strong background in analytical control strategy development and execution
• Demonstrated ability to develop talent through good mentoring skills. Experience with matrix management and peer to peer coaching.
• Demonstrated ability for taking initiative, creativity, and innovation in problem solving
• Background in Analytical Methodologies and sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications
• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development

• A strong team player with excellent oral and written communication skills; ability to work both independently for development of assays and cross-functionally for successful transfer of assays. Plan assay optimization and documentation to meet program deadlines.
• Authoring and reviewing internal technical reports, sections of regulatory filings (e.g., IND, BLA) and external scientific publications.
• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

Preferred Experience and Skills:

• Understanding of protein degradation mechanisms and link between analytical methodologies for analysis.
• Experience with qualification, validation, and transfer of assays to a GxP or regulated laboratory environment as listed in ICH Q2 and USP<1033>.
• Experience with complex glycan analysis and link to mechanisms of actions.
• Experience in analysis of various Biologic modalities (e.g., mAb, antibody-drug conjugate, fusion protein).
• Knowledge and experience in Antibody Drug Conjugate method development.
• Established scientific reputation supported by publications and external presentations.
• Strong external network to benchmark competitors and equipment vendors.
• Experience in high-throughput experimentation and data-rich experimentation.

Required Skills:

Analytical Method Development, Assay Development, Bioanalytical Analysis, Chromatographic Techniques, Clinical Judgment, Cross-Functional Teamwork, Dosage Forms, Ethical Compliance, Liquid Chromatography (LC), Matrix Management, Mentoring Staff, Method Validation, Personal Initiative, Stability Testing, Technical Writing

Preferred Skills: