Job Title: Scientist

Job Type: Exempt, Full-time (with flexibility to work extra hours as business needs dictate)
Reports to: Purification Manager

Summary
This position will be responsible for purification development activities within the
process development group, including process development, tech transfer, and scale-up
of cell harvest, chromatography, tangential flow and filtration steps. Additional
responsibilities will include assay characterization of development materials, support of
assay development and development of new purification technologies and methods.

Essential Functions
Responsibilities are primarily related to executing contract project work for Xcellerex
clients, including management of tech transfer of downstream unit operations,
reproducing and optimizing client processes at bench scale and scaling processes to
manufacturing scale. The scientist in this position will be responsible for performing
assays necessary to support purification development, as well as assisting in the
development of assay methods to support general process development efforts.
Additional responsibilities include the evaluation and development of new separation and
purification technologies, particularly to support conversion of unit operations to single-
use disposable systems.

Knowledge, Skills and Abilities

Qualified individuals will have a good understanding of protein chemistry and hands-on
experience developing and scaling up the following biotherapeutic process unit
operations: cell harvest by filtration and tangential flow, chromatography,
dia/ultrafiltration, virus removal. The ideal candidate will have additional experience with
some or all of the following: standardized / platform monoclonal antibody purification
methods as well as non-antibody proteins, GMP manufacturing, viral validation, process
validation and manufacture and optimization of affinity columns.

Supervisory Responsibilities
This position will work independently in matrix organization initially. In the future, the
position may oversee contractors and consultants as well as other less senior Process
Development associates.

Minimum Qualifications
A B.S./M.S./Ph.D. degree in Biochemistry or Chemical Engineering, or the equivalent
experience, would be most appropriate for this position. Ideally, individuals in this
position should have 5+ years (Ph.D. level) or 7+ years (M.S. level) or 9+ years (B.S.
level) biotechnology/biopharmaceutical industrial experience in protein chemistry and
purification development.