About the OrganizationMission Statement:
Oncobiologics is a publicly traded biopharmaceutical company focused on the advancement of its pipeline of biosimilar products, three of which are currently in clinical development. Led by a team of biopharmaceutical experts, Oncobiologics operates from a state-of-the-art 60,000 sq. ft. fully-integrated R&D and manufacturing facility in Cranbury, NJ. The company employs its BioSymphony development model to ensure that biologic drug product candidates meet the stringent requirements of U.S. and European regulators, while also pursuing accelerated development and technical excellence in creating affordable medicines for global patients who so urgently need them.
Oncobiologics provides a scientifically disciplined and speed-to-market approach to biologic drug development. By leveraging its scientific talent and technical infrastructure, the company has established a unique CMC engine designed to provide scientific rigor, speed and cost efficiencies. Through these capabilities, Oncobiologics is uniquely positioned to deliver a robust CMC package as required by the FDA, EMA and other regulatory bodies. The company is executing a commercial strategy to advance its drug product candidates to global markets.
Oncobiologics actively fosters a collaborative, entrepreneurial culture. With years of experience in both large and small organizations, the Oncobiologics team understands the critical importance of agile, rapid decision-making and strives to infuse all activities with urgency, creativity and disciplined thinking.
Founded January, 2011
Focused on the development of 'large molecules' (i.e., biologics)
Opportunity and Summary of Position:
Scientist II, Bioassay Development, will be responsible for the development, qualification and of robust biological test methods for biosimilar monoclonal antibodies. Methodologies include, but are not limited to cell-based proliferation assays, reporter gene assays, immune mediated cytotoxicity assays, binding assays and flow cytometry. Scientist will be accountable for the execution, analysis and reporting of experiments related to the development and characterization of biosimilars at all stages of development.
This position will report to the Associate Director, Bioassay Development.
Develop required biological assays for characterization, release and stability testing of therapies based on monoclonal antibodies. Methodologies include, but are not limited to ELISA, cell-based assays, SPR (Biacore) and flow cytometry.
Develop, qualify and validate required methods to global regulatory standards
Author and review test methods, protocols and technical reports
Provide training to scientists and other coworkers, as necessary
Maintain accurate and timely data records and documentation in both ELN and paper systems
The company is seeking an individual with the following qualifications and who is willing to make a long-term commitment to the organization:
B.S. or M.S in Biology, Life Sciences or equivalent
Qualifications and Skills
B.S. with minimum 2 - 4 years of experience, MS with minimum of 1 - 2 years of experience in the pharmaceutical industry preferably with assay development
In-depth understanding of the potency assays and its validation
Good conceptual, analytical, and organizational skills - must be detail-oriented, well organized, and able to work independently and in teams
A 'hands-on' energetic individual who enjoys challenges, a quick pace, and is capable and dedicated to getting the job done
Well-organized and accustomed to changing priorities and maintaining excellent records
Excellent verbal and written communication skills
Position Requirements LocationOncobiologics EOE StatementWe are an equal employment opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, national origin, disability status, protected veteran status or any other characteristic protected by law.