Principal Scientist, AR&D Mass Spec
The successful candidate will be responsible for development innovative analytical methods to test biological drug substances and drug products, the planning and execution of studies to support formulation development and manufacturing process development, analytical similarity studies, and release/stability testing using LC-MS-based detection. The incumbent must have the experience working in authoring SOPs and technical reports suitable for review by health authorities and mentoring other scientists. The successful candidate will be a highly motivated, well-organized, detailed-orientated scientist with the ability to work effectively in a fast-paced and multi-disciplinary environment.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Participate and lead in technology development and implementation by exploring novel concepts and innovative workflows to expand the group’s mAb analytical capabilities
- Participate in all phases of mass spectrometry laboratory operations including technology evaluations, the development of sample preparation and separation methods, data analysis, interpretation, reporting and follow up discussions with the project teams on utilizing the data in appropriate decision making.
- Application of regulatory guidance for assay development, data analysis, and biosimilarity testing.
- Development of bioassays for characterization and product release: binding, potency, effector function, downstream signaling, reverse-signaling, etc.
- Support drug substance and drug product manufacturing process development
- Transfer of analytical methodologies to other laboratories.
- Participate and/or lead cross-functional project teams.
- Author reports suitable to support regulatory filings and responses to inquiries from regulatory authorities.
- Represent the company in discussions with external parties (conferences, regulatory meetings, CROs/CMOs, business partners)
- Ph.D. in Pharmaceutical Sciences, Analytical Chemistry, Biochemistry with 10+ year’s relevant industrial experience.
- Familiar with ICH guidelines and USP/EP pharmacopeia requirements
- A strong theoretical understanding and experience in protein chemistry
- Expertise in development, characterization, and implementation of biomarker assays based on quantitative protein mass spectrometry for drug development.
- Experience and knowledge in operation of modern triple quadrupole and ion trap/orbitrap mass spectrometers and associated control and data analysis software systems.
- Knowledge and application of complex sample preparation methodologies as applied to quantitative protein mass spectrometry workflows.
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.
Notice To Agency And Search Firm Representatives
Adello Biologics is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Adello employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Adello. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.