Director, Biologics Analytical R&D Position Available In Union, New Jersey

Director, Biologics Analytical R D
Director, Biologics Analytical R D
remote type
Not Applicable
locations
USA – New Jersey – Rahway
time type
Full time
posted on
Posted 2 Days Ago
time left to apply

End Date:

July 20, 2025 (27 days left to apply)
job requisition id
R353709
Job Description
Our Research Scientists are our Inventors. We identify and target steps in disease mechanisms or pathways that could be inhibited or enhanced. Our goal is to isolate apound that is effective against a disease target. Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover the next medical breakthrough.
Our team in Rahway, New Jersey, is seeking an exceptional leader who is passionate about leading a team of Scientists to deliver analytical solutions that enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The Director, Biologics Analytical Research and Development (B-AR D) is responsible for providing strategic and technical leadership for analytical development of candidates from the discovery interface, through first product registration. The Director will be responsible for a team of approximately 10-15 scientists and a portfolio of approximately 3-5 programs at various stages of development. Strategic partnering with Biologics Analytical Research and Development method development GMP laboratories,plementary areas of Analytical Research and Development, Biologics Process Research and Development, CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in themercialization and manufacturing is essential.
The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art analytical techniques to solve problems, including strong background and experience in separations science, extensive experience with

UPLC/HPLC

analysis of biologics (e.g.

SEC, RP, IEX

), experience in micriobiological techniques, ELISA, PCR, cell based analytics, 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. The incumbent will be responsible for the recruiting, appraisal and development of personnel under her/his supervision.
The Director selects, trains, and effectively works with colleagues to action development plans of personnel under her/his direction within the framework of Company policy. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary (including merit and promotion planning). Maintaining a strong network internally and across the external academic and regulatorymunity is expected, as well as advancing a culture of scientific excellence,pliance mindset and collaboration with various partners and stakeholders in development.

Required Education, Experience and Skills:

Ph.D. in analytical chemistry or related field with 8+ years of relevant experience in the pharmaceutical industry; MS with 12+ years of relevant experience; BS with 15+ years of relevant experience.
Excellent verbal and writtenmunication skills, demonstrated creativity, strong interpersonal and collaborative skills
Demonstrated ability in leading cross-functional groups with proven talent development skillsets.
Ability to work in a team environment with cross-functional interactions is essential
Strength in delivering results on firm deadlines in support ofpound from development through Commercialization
A strong aptitude for and previous experience in managing inclusive scientific teams and attracting, developing, and retaining diverse talent.
Extensive knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.
#AR D