M.S. in chemical engineering, biochemical sciences, or related engineering/scientific disciplines with a minimum two years relevant experience, or B.S. in these disciplines with a minimum of 4 years of relevant experience.
Experience in bioprocessing, with a preferred background in downstream processing disciplines. Experience in one or more areas within biopharmaceutical process development, technology transfer, scale-up, and GMP batch execution/troubleshooting. Knowledgeable in all aspects and unit operations that comprise the bioprocess and biomanufacturing platform.
Experience in lab/pilot scale protein purification methods, including chromatography, ultrafiltration, depth filtration, centrifugation and buffer preparation.
Experience/knowledgeable in cGMPs and regulatory requirements.
Good written and oral communications skills.
Good organizational, collaboration, and teamwork skills.
Excellent troubleshooting/problem analysis skills
Strong interpersonal and leadership skills. Solid team player able to function within collaborative- and team-based organization.
Experience in project management and delivery, including ability to prioritize and forward plan courses of action.
Works independently with minimal to no direct supervision.
Experience with Lean Sigma and Root Cause Analysis methodologies highly desirable
Monitors processes in downstream operations. Collects information and prepares/maintains a campaign summary database of process knowledge, to be leveraged as assets progress in the biopharmaceutical development cycle. Analyzes results fully and recommends follow-up actions. Key participant in troubleshooting activities.
Ensures that development and documentation are sufficient to support consistent production and regulatory filings.
Prepares and/or approves documents for use in technology transfer and manufacturing. May also prepare or review documents for regulatory purposes.
Directs the development of technology essential to large scale cGMP production. Solves process and equipment problems. Recommends equipment and procedures. Keeps aware of new technology developments. Function as a technical expert in purification methods.
Responsible for technology transfer of Biopharmaceutical manufacturing processes from development groups or external partners to Operations or contract manufacturing organizations. Monitors technical operations of the process through communication with Bioprocess Associates. Coordinates efforts to transfer technology forward to contract manufacturers and other partners.
Coordinates activities between Development groups. Represents the Process Technology department at multi-disciplinary matrix teams. Presents results/conclusions at these meetings
Responsible for successfully troubleshooting production problems and for the technical success of multi-million dollar biopharmaceutical production campaigns.
Responsible for ensuring that manufacturing campaign data and supporting information is sufficient to support regulatory packages and filings.
Develops technologies essential to large scale or cGMP production.
Responsible for authoring and approval of batch documentation
Coordinates activities between various Biopharmaceutical Development and Supply groups (i.e. BioPPD/MPD, BPS, BQA, Analytical Tech. Transfer, MCCD/DPD, Validation, Engineering, etc). Represents the department in BioPPD/MPD teams and other multi-disciplinary matrix teams. Presents results/conclusions and contributes to the decision-making process within these teams.
Provides support for technology transfer from a CMO into Manufacturing Operations. May provide oversight of manufacturing activities at CMO. Some international and domestic travel may be required.
Prepares and may approve SOP's in areas of expertise.
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