Oncobiologics Cranbury , NJ 08570
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)
Design and perform process characterization studies for purification unit operations, including scale-down model studies, range studies, and resin lifetime studies.
Perform viral clearance studies at an offsite contract laboratory.
Evaluate chromatography resins and membrane adsorbers (e.g. Protein A, ion exchange, mixed mode, hydrophobic interaction) to be used in purification processes and process models.
Develop scalable chromatography methods that maximize efficiency of operations in manufacturing.
Develop scalable filtration processes including methods for depth filtration, tangential flow filtration, and viral clearance. This should include working knowledge of filter capacity screening and evaluation.
Author and review documentation, including but not limited to, technical transfer protocols and development reports.
Prepare and review documents associated with technical transfers of developed processes to manufacturing partners (either internal or outsourced)
Represent purification development in team meetings as required.
Maintain a current electronic laboratory notebook with scientific rigor to meet project needs for process development.
Execute process development enabling analytics required to make development decisions rapidly.
Operate safely and according to company environmental requirements.
The company is seeking an individual with the following qualifications:
B.S/M.S/Ph.D Biochemistry, Chemistry, Chemical Engineering or equivalent field.
Qualifications and Skills
Minimum 12+ years of experience in absence of graduate degree, 8+ years if MS, or 6+ years with PhD.
Experience in developing chromatography and filtration scale-down models for use in protocol driven process characterization and validation activities.
Demonstrated ability in all modes of chromatography including column packing and buffer/solution preparation.
Demonstrated ability in filtration principles and practice including general operation as well as capacity determination.
The applicant should have a working knowledge of the progression of "micro" scale purification development through confirmation of process at pilot scale.
Experience in viral clearance studies.
Must be familiar with GMP guidance(s) and support clinical and commercial manufacturing with appropriately developed process.
Have a working knowledge of purification instruments and their associated software (specifically GE Healthcare AKTA instruments and Unicorn software).
Should have experience with HPLC/UPLC, experience with electrophoretic methods and ELISA is a plus.
Excellent communication skills in English, both verbal and written, and the ability to interface effectively with analytical, process, and business development is required.
Good conceptual, analytical, problem solving, and organizational skills must be detail-oriented, well organized, and able to work independently and in teams.
The ability to listen to, learn about, and build upon organizational best practices and successes.
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.