Scientist I – Purification Sciences

Bora Biologics USA•Rockville, MD

About The Position

This position is responsible for the design, execution, and reporting of process characterization and process validation studies for programs entering late-stage development. The successful candidate will have a good understanding of the role of characterization and validation studies in process development, with excellent attention to detail and record keeping, and strong communication skills. The individual may also contribute to the development of novel processes or optimization of existing processes for programs in an earlier stage of development. The position necessitates a collaborative approach with other Development functional groups, Manufacturing, Validation, and Regulatory Affairs, towards the goal of transitioning products from development to commercialization.

Requirements

BS with a minimum of 4 years of experience, MS with a minimum of 2 years of experience or PhD with no previous experience
Minimum of 4 years of biotech industry experience
Possess in-depth understanding of downstream unit operations
Understanding of downstream process development and process transfer to manufacturing
Experience operating purification equipment such as ÄKTA or equivalent
Familiarity with small-scale model studies using Design of Experiments (DoE) approach
Familiarity with process validation at both small and large-scale
Excellent technical writing skills and oral communication skills
High energy results-driven individual
Willingness to be hands on
Experience performing biologics analytical techniques (HPLC, Capillary Electrophoresis, ELISA)

Responsibilities

Design process characterization and process validation studies and author protocols.
Execute process characterization studies to establish process understanding and define critical process parameters.
Support process validation activities by executing studies and interpreting results.
Maintain accurate laboratory records and ensure activities are conducted in compliance with applicable quality and safety requirements.
Generate, interpret, and communicate experimental results through technical reports, presentations, and development summaries for both internal teams and clients.
Collaborate with analytical, upstream, formulation, and manufacturing teams to support integrated process development activities.
Other duties as required