SCIENTIST -BIOTHERAPEUTICS

SCIENTIST, MANAGER -BIOTHERAPEUTICS

Pursuant to Section 20 C.F.R. 656.10, you are hereby notified that an application for Alien Employment Certification will be filed by Inotiv, Inc. for the following job opportunity:

JOB LOCATION: Rockville, MD

POSITION: Scientist Manager - Biotherapeutics

POSITION DESCRIPTION: Responsible for bioanalytical method development (PK, immunogenicity, biomarkers, DNA, RNA, genomics, flow), validation and sample analysis in support of preclinical and clinical drug development. Oversee all immunogenicity studies; Oversee and manage associate scientists and scientists and allocate studies to them. Provide direction and guidance to new and junior scientists; Author and review technical documents (protocols, analytical reports, SOPs and raw data summaries); Collaborate with the director to develop innovative bioanalytical techniques in support of contemporary therapeutic strategies discovered by Inotiv's client base; Act as study director/study manager/project manager/manager/principal investigator requiring timely feedback to clients on projects and overall responsibility for the project. Up to 10% remote work allowed; must live within normal commuting distance of Rockville, MD. 14% domestic and 1% international travel required.

REQUIREMENTS: PhD degree in Genetics, Biotechnology, Molecular Biology/Immunology or related field or foreign equivalent degree plus 2 years of Biotherapeutics experience (Bioanalytical). Required skills: Develop and Validate Immunoassays (PK, ADA and Nab) using MSD, RIA, ELISA, ACE and GYROS format for novel pharmaceutical drugs; Manage preclinical and clinical studies of novel pharmaceutical under regulatory compliance FDA/GLP/OECD/CLIA for IND/NDA submission; Analyze and manage data using scientific Software Watson LIMS, Softmax Pro, STATLIA, eDOCS, ELN and PDS; Collaborate with sponsors, sites, and vendors; Write technical documents including SOPs, validation plans, analytical plans, study reports and deviations; Manage IQ, OQ and PQ for lab automation liquid handling systems, TECAN, GYROLAB and Hamilton. Up to 10% remote work allowed; must live within normal commuting distance of Rockville, MD. 14% domestic and 1% international travel required.

Full time. $121,000 - $131,000/year. Competitive compensation and benefits.

Please apply on-line at https://careers.inotiv.com/ and search for Job Posting Number JR100198

Any individual may provide documentary evidence bearing on this application, with information on available workers and information on wages and working conditions, to the Certifying Officer, U.S. Department of Labor, Employment and Training Administration, Office of Foreign Labor Certification, 200 Constitution Avenue, NW, Room N-5311, Washington, DC 20210

*This position could be offered at different levels for candidates who qualify with a combination of advanced levels of education and/or years of experience. The salary range will adjust along with the level of the role to match the person's relevant experience and/or education level.

Inotiv is a growing contemporary drug discovery and development company where we "Play to Win" in an industry rich with opportunity. Together, we face challenges and together we win in the delivery of world-class drug discovery and development solutions that impact the health and well-being of people all over the world. There's an opportunity for everyone at all phases of a career, each individual's unique skill set has an impact on the work we conduct. If you have the talent and desire to impact the quality of people's lives, we have the career opportunities to make it happen. Join us in embracing research and science to impact the health and well-being of people all over the world.

Salary will be commensurate with experience and responsibilities. Benefits include health and dental coverage, short- and long-term disability, paid time off, paid parental leave, 401K, and more!

Inotiv is an Equal Opportunity Employer. It is our policy to provide a fair and equal employment opportunity to all persons, regardless of age, race, color, religion, sex, gender, gender identity, gender expression, sexual orientation, genetic information, disability, national origin, veteran status, or any other basis prohibited by law. This policy governs all aspects of employment, including selection, job assignment, compensation, discipline, termination and access to benefits and training.