The individual will be a key member within a group responsible for performing large scale upstream operations/development, including the cell expansion, cell culture, and clarification of non-GMP batches to support development timelines and manufacturing support. They will seamlessly collaborate within the framework of cross-functional process development teams including engineers and manufacturing teams. They will be possess excellent problem solving abilities, hold strong coaching and supervisory skills, and communicate well within our multi-disciplinary environment including manufacturing, quality, and manufacturing technical support teams.
70% -- Lead/Perform non-GMP cell culture campaigns (pilot scale) to support new product development, material supply needs and demonstration runs for multiple programs spanning all phases of biopharmaceutical development. Support the transfer of all information including long lead items, batch record development, sample plan building, and on-floor support schedules. Record and trend data in conjunction with key stakeholders.
15% -- Actively participate and interact with Process development groups troubleshooting problems, supporting large scale studies, and supporting project goals. Design and develop pilot scale operating procedures and records suitable for use in the production of non-GMP material
10% -- Evaluate and implement novel large scale technologies that meet a generic platform across multiple processes
5% -- Assist in the maintenance of a clean and orderly facility
Education and Experience Requirements
- B.S. with 2+ or M.S. with 1-3 years of experience in biology, biochemistry, biotechnology, chemical engineering or related field.
- Relevant Work Experience Requirements:
- Work experience must be in a Process Development or Manufacturing setting.
- Must have hands-on experience working with bioreactors/fermenters from bench top to production scale, including process monitoring and process control utilizing a Delta V platform.
- Experience with bulk clarification via depth filtration.
- Experience with ultrafiltration/infiltration is a plus.
- Working knowledge of the Microsoft Office suite is essential.
Key Skills, Abilities, and Competencies
- Ideally, the candidate should possess experience and knowledge of activities routinely performed in upstream manufacturing (vial thaw, cell culture expansion, large scale bioreactor setup and control, centrifugation, depth filtration, UF, and media/buffer preparation). Knowledge of downstream purification processing is a plus. The candidate should have process scale-up experience or manufacturing experience.
- The candidate must demonstrate excellent written and verbal communication skills and have an ability to independently operate pilot scale equipment, interpret data and maintain an organized lab area. In addition, the individual should be a self starter and be able to communicate effectively with external and internal stakeholders. Candidate must have excellent problem solving skills and be able to work in a fast paced team environment.
- Knowledge of Unicorn or Delta V software is required. Experience with single use bioreactors is preferred.
- Document development activities accurately in research notebooks and batch records as per corporate guidelines. Provide concise reports and updates to management as required.
Complexity and Problem Solving
- The candidate will be expected to effectively complete day to day operations while, managing data and communicating with external stakeholders. The candidate will be expected to work closely with PD operations management, deliver detailed updates and display sense of urgency while completing critical tasks. The candidate will be expected to provide solutions to help trouble shoot pilot scale operations and central service related issues.
Internal and External Contacts
Contacts are primarily with the Manager (supervisor) and other process engineering professionals in PD and Manufacturing; regular contacts with other groups within PD. Contact with Facilities personnel on a non-routine basis.
Location/Region: Lexington, MA