Scientist/engineer I

Bristol Myers Squibb Syracuse, NY
POSITION SUMMARY:

The Manufacturing Technology Scientist/Engineer will support Manufacturing Operations (upstream processing, inoculum, cell banking, facilities and materials management) on a daily basis, as well as lead or contribute to strategic projects.

Duties/Responsibilities:

* Champion opportunities focused on productivity, robustness, quality, business process, and safety improvements.

* Regular and frequent on-floor observation to support and improve manufacturing.

* Lead Quality Investigation teams to determine root cause

* Assess product impact and identify appropriate CAPA.

* Originate, review and evaluate change controls.

* Support PPQ and BLA filings including on-floor support, data verification and data analysis.

* Receive technical transfer of new molecules, perform facility fit and lead implementation of product/process into the manufacturing facility.

* Collect process data, perform statistical analysis and identify opportunities for improvement of process performance.

* Author protocols and final technical reports for requested initiatives/ studies.

* Review manufacturing batch records (MBR), standard operating procedures (SOP), and other cGMP documentation, as required.

* Follow cGMP requirements.

* Participate in network-wide alignment and optimization of Manufacturing Technology business processes.

QUALIFICATIONS

Specific Knowledge, Skills, Abilities, etc:

* Experience should include technical support of a cGMP Biologics manufacturing facility, including knowledge of upstream processing unit operations (including cell culture, bioreactor operation and primary recovery).

* Demonstrated problem solving ability, experience with manufacturing systems and equipment, good interpersonal, oral and written communication skills are essential. Operation Excellence experience and project management skills are desired.

* Technical writing and data presentation abilities are requirements.

* Experience with biopharmaceutical regulatory submissions and interaction with regulatory agency inspectors is a plus.

Education/Experience/ Licenses/Certifications:

* The successful candidate will have a PhD in Chemical or Biochemical Engineering or a related discipline with 2+ years of relevant experience, an MS with 4+ years relevant experience, or a BS with 6+ years relevant experience.

Physical Demands:

This position is primarily an office-based role and requires repetitive use of hands and wrist (computer work), and infrequent lifting of items not to exceed 50 lbs. Occasional bending, twisting and stooping to allow for gowning into classified environment required.

Work Environment:

This position is primarily office based with occasional work in a classified GMP manufacturing environment. Work will take part both individually and as part of a group.

Travel:

* This position requires up to 5% of travel.