About the position
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 a compound 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, complementary 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 the commercialization and manufacturing is essential. The successful candidate must function well and be able to collaborate in a fast-paced, integrated, multidisciplinary team environment.
Responsibilities
- Provide strategic and technical leadership for analytical development of candidates from discovery to first product registration.
- Lead a team of approximately 10-15 scientists and manage a portfolio of 3-5 programs.
- Collaborate with Biologics Analytical Research and Development method development GMP laboratories and other departments.
- Manage recruiting, appraisal, and development of personnel.
- Plan resources proactively and assess risks.
- Maintain a strong network internally and externally in the academic and regulatory community.
- Advance a culture of scientific excellence and compliance.
Requirements
- Ph.D. in analytical chemistry or related field with 8+ years of relevant experience; MS with 12+ years; BS with 15+ years.
- Excellent verbal and written communication skills.
- Demonstrated creativity and strong interpersonal skills.
- Proven ability in leading cross-functional groups.
- Experience in managing inclusive scientific teams.
- Extensive knowledge of regulatory guidance and quality standards.
Nice-to-haves
- Experience in separations science and UPLC/HPLC analysis of biologics.
- Background in microbiological techniques, ELISA, PCR, and cell-based analytics.
- Knowledge of Critical Quality Attributes/QbD/DOE principles.
Benefits
- Medical, dental, vision healthcare and other insurance benefits for employee and family.
- Retirement benefits, including 401(k).
- Paid holidays, vacation, and compassionate and sick days.
