Principal Scientist / Senior Scientist, Downstream Bioprocess Development
Adello Biologics is a privately held, U.S.-based biotechnology company that leads with science to accelerate development and drive manufacturing efficiency. The company's aim is to provide high-quality, affordable biosimilars to patients worldwide. Headquartered in Piscataway, NJ and driven by a team of highly skilled industry veterans, Adello is advancing a strategic pipeline of proteins and complex monoclonal antibodies with lead candidates in oncology and immunology. For more information, visit www.Adellobio.com
Our vision is to make biosimilar medications affordable. We are seeking candidates interested in contributing to a bourgeoning field that has the potential to help millions of patients. As a growing company, Adello Biologics offers real development opportunities for candidates excited to take on responsibility, make an immediate impact and help us achieve our vision. As part of a close knit team, you’ll have the opportunity to work in a unique, high science industry while expanding your career. We are seeking a Principal Scientist / Senior Scientist, Downstream Bioprocess Development to be based out of our HQ in Piscataway, NJ.
The Downstream Principal Scientist / Senior Scientist, Process Development, is a regular employee in a full-time exempt position at Adello Biologics, LLC, in Piscataway, NJ. Adello Biologics is a science-based biopharmaceutical company that develops, manufactures, and commercializes biosimilar medicines. This employee will perform and provide hands-on direction for downstream process development, process optimization, technology transfer and cGMP manufacturing related activities. This position requires extensive technical expertise in mammalian cell-based purification processes including monoclonal antibodies, knowledge in cGMP manufacturing and understanding of regulatory requirements. Experience with microbial process development is a plus.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
- Performs downstream process development, optimization, characterization, scale-up, technology/process transfer for cGMP manufacturing, process troubleshooting and data analysis.
- Provides technical direction for the development of purification processes.
- Executes small-scale validation studies.
- Implements novel technologies to aid in reaching project and technical goals.
- Develops new technologies to advance the capability of the company
- Ensures a healthy and safe working environment and to comply with federal and state regulations in regard to the same.
- Develops study plans and ensures such plans are in place before work commences.
- Maintains laboratory notebooks for all projects and ensure that they adhere to company policies.
- Communicates (presentation and/or in writing) to project teams and upper management.
- Work on cross-functional teams representing bioprocess group.
- Authoring technical reports and related regulatory documents.
- A Bachelor’s degree, a Master’s degree, or a Doctorate degree in chemical, biological, or biochemical sciences.
- PhD 8 -10 years of experience, Master’s degree 12+ years of experience and Bachelor’s degree 15+ years of experience is required.
- Experience must be in relevant process-demonstrated skill in column chromatography, column packing/unpacking, ultrafiltration/diafiltration, and sterile filtration operations.
- Knowledge in process scale-up, process transfer and cGMP operations.
- Experience with authoring regulatory documents.
SPECIALIZED KNOWLEDGE AND SKILLS:
- Excellent verbal, written and organizational skills.
- Must be able to understand, read, write, and speak English fluently.
WORK ENVIRONMENT AND PHYSICAL DEMANDS:
General Work Environment:
- Standard office environment for deskwork.
- Significant amount of time doing computer work (reading, writing, reviewing, and editing documents).
- Extensive time in cleanroom laboratories also required.
- No extraordinary noise levels.
- Must be able to lift 25 lbs.
- No extraordinary requirements.
- High-paced demanding environment to meet ambitious project goals.
- No regular travel required. Some domestic and international travel may be required.
Adello Biologics, LLC provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Adello Biologics, LLC complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, and transfer, leaves of absence, compensation and training.