Principal Scientist Biophysical Characterization

Location
Piscataway, NJ
Posted
Sep 06, 2018
Ref
2018-2175
Required Education
Doctorate/PHD/MD
Position Type
Full time

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, Biophysical Characterization to be based out of our HQ in Piscataway, NJ.

The Principal Scientist, Biophysical Characterization will be responsible for the development, qualification, verification and technical transfer of characterization methods routinely performed during biologics development. Methodologies include but are not limited to DSC, CD, FT-IR, MFI, AUC, HPLC and mass spectrometry. He/ she will be the technical expert in physico-chemical properties of proteins and responsible for planning, designing, and executing through multiple stages of development. In addition, he/ she will actively train and mentor junior scientists. 

Qualifications & Experience:

Required:

●      Practical knowledge of methodologies such as DSC, CD, FT-IR, NMR, AUC, DLS/ MALLS, Fluorescence spectroscopy is required.

●      This individual should have demonstrated fundamental knowledge of protein structure and degradation mechanisms including chemical stability, physical stability, interactions with common excipients etc.

●      Strong command over data analysis and fitting of various kinetic and thermodynamic models.

●      Understanding of ICH requirements in relation to characterization method development, qualification & verification.

●      Prior experience in authoring relevant sections of regulatory dossiers and addressing health authority questions.

●      Good conceptual, analytical, problem solving, and organizational skills – must be detail-oriented, and able to work independently and in teams.

●      Excellent communication skills, both verbal and written, and the ability to interface effectively with functional groups.

●      Highly motivated, self-driven individual, well-organized with record-keeping, and adaptable to rapidly changing priorities.

Preferable:

●      Additional experience with aggregate characterization and sub-visible particle analysis (HIAC, MFI) and mass spectrometry is desirable.

PREREQUISITES:

Education:

  • Ph.D. in Biochemistry, Pharmaceutical Sciences, Chemistry or equivalent with 8+ years of biopharmaceutical industry experience in antibody/protein characterization.

Job Responsibilities:

●      Lead efforts related to method development, qualification and validation, including preparation and review of protocols, SOPs and reports.

●      Lead the sample analysis for similarity assessment, formulation and process development, CQA assessment, stability studies, and forced degradation studies.

●      She/he will be responsible for planning, execution, analysis, and reporting of experiments related to the development of primary, secondary, tertiary and higher order structure characterization techniques.

●      Internal expert on data interpretation, applications, instrumentation and trouble shooting.

●      Analyze, summarize, and present experimental results

●      As a member of multidisciplinary project team, this individual will work closely with internal and external collaborators, CRO’s, in academia and industry.

●      Train and mentor junior scientists

●      Maintain accurate data records and documentation

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.