Open Position
Title: Analytical Development Scientist/Senior Scientist
Location: Remote
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE within the subject line.
Organizational Overview
TG Therapeutics is a fully integrated, commercial stage, biopharmaceutical company focused on the acquisition, development and commercialization of novel treatments for B-cell diseases. In addition to a research pipeline including several investigational medicines, TG has received U.S. Food and Drug Administration (FDA) approval for BRIUMVI® (ublituximab-xiiy), for the treatment of adult patients with relapsing forms of multiple sclerosis (RMS), to include clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease, as well as approval by the European Commission (EC) and the Medicines and Healthcare Products Regulatory Agency (MHRA) for BRIUMVI to treat adult patients with RMS who have active disease defined by clinical or imaging features in Europe and the United Kingdom, respectively. TG Therapeutics is headquartered in Morrisville, North Carolina. For more information, visit www.tgtherapeutics.com.
Role
The Analytical Development Scientist position is responsible for supporting the management of outsourced analytical methods across a global network of vendors in a fast-paced environment. They assist in shaping the strategy and overseeing the execution of assay validation, transfer, optimization and troubleshooting processes that align with the needs of commercial and clinical manufacturing. The AD Scientist effectively collects and analyzes data to build and communicate an understanding of assay and product behavior that will be used to justify data-driven proposals and recommendations, and understands how to extrapolate technical issues into the broader context of business operations.
This is a remote position with occasional travel as needed.
Key Responsibilities
––Acts as Subject Matter Expert on potency methods such as immunoassays and cell-based assays.
––Interfaces with Contract Laboratories conducting testing to provide technical guidance and ensure continuity of daily operations.
––Provides support for OOS and OOT testing results, investigations and method troubleshooting.
––Collects, trends and analyzes data such as assay failure rate and other parameters to understand method status.
––Connects method status to the overall TG business operations. Collaborates with Quality and Manufacturing to facilitate the analysis of data related to various testing phases (such as lot release testing, stability, characterization and assay qualification/validation).
––Collaborates with Quality to ensure testing compliance and conduct document writing and reviewing.
Professional Experience/Qualifications
––PhD plus 1-2 years of industry experience or MSc plus 5 years of industry experience.
––Hands-on experience of potency bioassay execution on bench required (cell-based assays and ELISA).
––Strong technical experience with cell-based potency assays; ADCC and CDC experience preferred.
––Experience with potency method validation, transfer and troubleshooting.
––Knowledge of bioassay development and USP bioassay guidelines.
––Excellent communication skills and experience presenting data in cross-functional meetings.
––Desired: Experience with management of outsourced analytical work in a pharmaceutical development or commercial environment.
––Desired: Experience supporting regulatory filings.
Education
––PhD or MSc in biological sciences, chemistry, biochemistry or related areas.
TG Therapeutics is an equal employment opportunity employer, and does not discriminate on the basis of race, color, religion, gender, sexual orientation, gender identity or expression, age, disability, national origin, ancestry, genetic information, military or veteran status, pregnancy or pregnancy-related condition or any other protected characteristic.