We are rapidly growing and seeking a talented individual to join our microBiomanufacturing center as a Associate III, Manufacturing, based in our Hopkinton facility in Massachusetts.
Essential Duties and Responsibilities
This is a hands on lead position responsible for team’s execution of GMP activities on the production floor. Performs functions associated with cGMP manufacturing operations within multisuite biologics production facility. Setup and operate manufacturing equipment such as wave tables, single use bioreactors, centrifuges, TFF skids, chromatography skids and filtration. Perform in process testing such as titrations, cell viability, pH, DO, metabolite profile.
- Perform upstream and downstream processing steps such as cell growth (using incubator, wave system, single use bioreactor), filtration, chromatography, column packing with demonstrated proficiency for equipment operation, maintenance, and troubleshooting
- Ensure all manufacturing processes are performed according to standard operating procedures
- Perform aseptic technique in a biological safety cabinet, including cell manipulations, filtration, sampling and aseptic filling
- Perform in process testing using equipment such as pH, conductivity, cell counter, spectrophotometer, microscope
- Accurately and legibly perform calculations and complete CGMP paperwork such as batch records, logs and forms ensuring adherence to good documentation practices
- Coordinate production batch material deliveries
- Maintaining necessary supplies to support manufacturing activities
- Model excellent leadership behaviors to other staff, including training and providing constructive feedback
- Author documents related to CGMP operations including batch records, procedures, work instructions and forms
- Provide technical support to ensure well managed execution of technical transfers, process changes, validations and pilot studies
- Support investigations, deviations, CAPA, and change controls
- Support external and internal audits
- Proactively identify issues, perform troubleshooting, escalate issues and work towards solutions
- Champion business excellent and continuous improvement projects, such as visual management and 5S
- Additional responsibilities will be assigned as necessary
- BS required, preferably in life sciences including biology, immunology, biochemistry, process engineering or a similar biological science
- Bachelor’s degree with 8+ years in a Manufacturing or related role within the biotech/pharmaceutical industry, or Master’s degree with 4+ years’ academic/pharmaceutical/biotech industry experience
- Must have proven hands on experience with GMP pharma unit operations
- Knowledge of cGMP requirements with an understanding of phase-appropriate clinical and commercial expectations
- Experience as an author/contributor/reviewer of batch records, SOPs, technical protocols, data and final reports
- Task and team-oriented, analytical, organized, detail-oriented, self-motivated and ability to multitask
- Exceptional communication and interpersonal skills including facilitating teams discussions and ability to speak effectively before groups of customers.
- Lean manufacturing, 5S and LDI training preferred
- Proficient with MS Outlook, Word, Excel and PowerPoint, and other electronic systems.