Position Overview:

We have an immediate opening at Director level for an individual responsible for leading a group of scientists (Ph.D, M.S. and B.S. level) developing immunoassays using various methods in order to measure drug (PK), anti-drug antibodies, drug neutralization, characterization of anti-drug antibodies or biomarkers evaluating drug safety or efficacy of a drug.

Job Responsibilities: 

Provides scientific expertise in developing new methodologies, write and review protocols, evaluate data and interface in compliance with regulatory agencies. Identify and Develop new capabilities and resources to meet both present and future needs of the group. Create an employee empowered work environment that is both stimulating and rewarding.

Basic Qualifications:

• Ph.D. in Biochemistry, Immunology or related field.

• A minimum of 5-7 years of experience in a biopharmaceutical company leading a group developing various immunoassays and interacting with regulatory agencies such as FDA, EMEA.

• In-depth knowledge of GLPs, SOPs and regulatory guidelines is essential.

• Candidate must have a proven track record and hands on experience developing various immunoassays detecting drug or drug induced antibodies.

• Ability to understand heterogeneous data and communicate effectively with management as well as laboratory personnel