Open Position
Title: Associate Director/Director, Upstream MSAT
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.
Role
The Assoc. Director/Director, Upstream MSAT is responsible for upstream processes for commercial and clinical biopharmaceutical drug substance manufacturing at contract manufacturers. This includes cell culture, cell banks, viral safety testing and includes seed train/bioreactor/harvest unit operations.
Key Responsibilities
––Responsible for upstream processes for commercial and clinical biopharmaceutical drug substance manufacturing at contract manufacturers. This includes cell culture, cell banks, viral safety testing and includes seed train/bioreactor/harvest unit operations.
––Scope includes support of drug substance commercial manufacturing, continuous improvement of manufacturing and cost, technology transfer and validation, partnering with supply chain, quality and regulatory groups.
––Prepare and review CMC documentation for upstream sections of regulatory filings including post approval filings with US and EU
––Provide leadership on strategy and execution of process validation, regulatory, experimental design and areas related to upstream commercial manufacturing and process improvement.
––Manage the upstream MSAT group.
––Analyze and trend process development, process characterization, and manufacturing data.
––Author and review clear and concise technical reports.
––Work with cross functional teams to meet company goals
Professional Experience/Qualifications
––PhD in chemical engineering or related area with 10+ years of industrial experience in the biopharmaceutical industry.
––Demonstrated experience in developing cell culture processes for the production of biopharmaceuticals.
––An understanding of the cGMP for biopharmaceuticals, with experience in technology transfer to manufacturing sites, preferred at large scale (≥15,000L)
––Experience with process scale-up, characterization and validation, process control strategy, multivariate analysis and DoE.
––Experienced in authoring of CMC sections for commercial regulatory filings.
––Supervisory experience leading a technical team.
––Remote position, available for infrequent travel including international.
––A can-do attitude to join a dynamic, team-based, small but growing biotech with a diverse range of opportunities for personal and professional growth.
Education
PhD in chemical engineering or related area with 10+ years of industrial experience in the biopharmaceutical industry.
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.