BIOLOGICS MANUFACTURING ENGINEER
Serves as a process technical expert to large scale cell culture and harvest unit operations for the commercial.
Manufacture of biopharmaceuticals at Devens. This position offers the opportunity to resolve complex problems while meeting quality, schedule, and cost objectives. The successful candidate will be a key contributor in a dynamic and highly collaborative team environment. The candidate will set appropriate objectives and priorities, overcome obstacles; and deliver results within project timelines.
Expertise and experience in one or several aspects of the design, control, and operation of large scale inocula, seed train, bioreactor, filtration and centrifugation unit operations are highly desired. Demonstrated skills in cross-functional partnerships, supporting cross functional teams and knowledge of regulatory and cGMP requirements are required.
- Supports the preparation of CMC documentation for regulatory filings and responses for the Devens commercial.
- Ability to analyze large data sets using advanced statistical and modelling methods to drive solutions in a fast paced environment.
- Provides technical expertise for investigation and resolution of process deviations, root cause investigation, CAPAs, process improvements, review and approval of change controls.
- Supports commercial manufacturing via in-plant coverage and real-time process upset troubleshooting.
- Evaluates process performance through statistical analysis with recommendations generated for process enhancement.
- Supports upstream aspects of process technology transfer and process validation through individual technical
This 6+ month position starts ASAP.
Please E-MAIL your resume (attachment to email) with rate and availability to Karen: email@example.com
ALPHA'S REQUIREMENT #17-00889
- BS or equivalent with 2-4 years relevant experience, MS or equivalent with 2 years relevant experience.
- Proficiency of SOPs, cGMPs and the know how to work and manage within a regulatory environment.
- Experience in successful execution and management of process technical transfer.
- Experience in designing and executing process and equipment validation plans.
- Experience in the design, modification and optimization of biologics cell culture unit operations.
- Experience in investigating process deviations and developing issue resolving CAPAs.
- Proven project management skills and effectively balancing project assignments with other duties.
- Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors.
- Excellent verbal & written communications skills.
- Principal assignment is in a modern LSCC building which requires adherence to various Personal Protective Equipment (PPE) standards.