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 transitions to a commercial operation, the CMC Biologics group in Waltham, MA is expanding to support both clinical and commercial work. TG has had much success leveraging contract manufacturers to produce therapeutic proteins at large scale. This position will support upstream and downstream development, technology transfer, validation and manufacturing for clinical and commercial programs. As a virtual company, all work is outsourced so this individual will work with both the internal team and outside contractors. A background in upstream or downstream process development and/or manufacturing is required given that data analysis is a part of this position. This position will start out remote but transition to working with the team at the Waltham, MA office when public health conditions allow.
––Responsible for supporting upstream and downstream biologics drug substance work on 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 upstream and downstream 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 0-4 years of relevant experience.
––Strong analytical skills in order to address control strategy development and statistical analysis.
––Experience with process scale-up, process characterization, validation and GMP is 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