Title: Engineer/Scientist, CMC Biologics
Location: Waltham, MA
If you are interested in the below position, please send your resume to [email protected] and REFERENCE THE POSITION TITLE AND REGION within the subject line.
As TG Therapeutics transitions to a commercial operation, the CMC Biologics group in Waltham, MA is expanding to support both development of the biologics pipeline, including commercialization of its lead biologic asset. There are two positions – one for upstream and one for downstream work. Each position will support process development, technology transfer, validation and manufacturing. As a virtual company, all work is outsourced so this individual will work with both the internal team and outside vendors. This position will start out remote but transition to working with the team at the Waltham, MA office when public health conditions allow. This is a great opportunity for an early career professional to experience working in a start-up environment, work with managers with decades of experience, and take his/her career to a new level.
––Responsible for supporting cell culture or recovery/purification of clinical and commercial biopharmaceutical drug substances supplied by third party vendors.
––Scope includes support of process development, manufacturing, tech transfer, scale-up, and validation
––Help prepare and review CMC documentation for drug substance sections of regulatory filings.
––Support the strategy and execution of process validation, regulatory, experimental design and related aspects.
––Analyze and trend process development, process characterization, and manufacturing data.
––Author clear and concise technical reports.
––B.S. or M.S. in chemical/biochemical engineering, biochemistry, or related area with 1-4 years of relevant experience.
––An understanding of the cGMP requirements of manufacturing processes for biopharmaceuticals.
––Experience with process scale-up, process characterization and/or validation
––Familiarity with control strategy development, statistical analysis and DoE a plus
––Effective written and oral communication skills.
––A can-do attitude to join a dynamic, team-based, small biotech with a diverse range of opportunities for personal and professional growth.
Bachelors or Masters degree