UPSTREAM BIOPROCESS TECHNICAL LEAD

The BIOPROCESS TECHNICAL LEAD works on routine manufacturing assignments as well as assignments that are very complex in nature where independent action and a high degree of initiative are required in resolving problems and making recommendations. The ideal candidate will strive for “right first time” through adherence of GMP activities.

Responsibilities:

• Change control identifiers – works in conjunction with bioprocess associate/specialists to identify key improvements initiatives and direct changes to project leads for initiation.
• Investigation identifiers – initiate investigation following alignment with QA floor.
• Communicate and resolve operational variances.
• Serve as the “acting” Shift Supervisor/Manager in absence of Shift Supervisor/Manager – Coordinate, direct and oversee work execution and manage personnel related issues.
• Executes real time process monitoring – including equipment and key process parameters review and work with Shift Supervisor/Manager to drive required decisions.
• Drive implementation of process enhancement and new technology in partnership with Project lead and Manufacturing Technology team.
• Participate in performance review discussion.
• Leads complex investigations on floor – drives technical issues in working with cross functional team members.
• Support real time process reports review and resolve open issues.  Trend issues and strives to right first time.
• Technical trainer for the shift – provides consistent training to the staff.
• Execute and drive continuous improvements.
• Support tech transfer team through active participation in ensuring that new process can fit and be executed in sustainable manner.
• Being resource to support routine investigations and CAPAs– author, review, approval, in case of excess investigation beyond planned capacity.
• Assigned area owner – drive facility upkeeps.
• Adheres to Good Manufacturing Practices and standard operating procedures.
• Weighs and checks raw materials.  Assembles, cleans and sterilizes process equipment, monitors processes.
• Completes electronic work instructions and maintains clean room environment to comply with regulatory requirements.
• Operates and trains others all production equipment within the assigned functional area (i.e. Upstream: Media formulation equipment, glass washers, dispensary, media prep, inoculum, bioreactors, harvest equipment)
• Effectively uses process automation systems (i.e. Delta V and Syncade Interactions, OSI/Pi Historian) and some supporting business systems (i.e. SAP. Trackwise, Maximo etc.).
• Ensures less experienced manufacturing personnel comply with Standard Operating Procedures (SOPs) and electronic work instructions and that training is completed on time.
• Assists with the coordination and implementation of special projects such as validation or complex investigations.
• May provide scheduling and work assignment guidance to peers.  Modifies group work plan, schedule or assignments to meet shift/unit priorities, maintains operational efficiency, making corrections as necessary, regularly provides training and operational guidance to other staff.  Advises Shift Supervisor/Manager on improvements which may optimize work processes and informs of work issues requiring management action.

Qualifications:

• B.S., in science, engineering, biochemistry or related discipline, or its equivalent is highly desired.
• A minimum of 5+ year’s process operations experience in a highly automated biotechnology manufacturing facility subject to Good Manufacturing Practices (GMP) regulations.
• Practical knowledge of regulations such as GMP and company Standard Operating Procedures (SOP) and strong technical and operational knowledge of either upstream and/or downstream unit operation is essential.
• Demonstrated experience in solving complex technical issues in biologics manufacturing.
• Prior evidence of successful participation on work teams where combined contribution, collaboration, and results were expected
• Demonstrated proficiency in common computer tools such as word processing, spreadsheet and web based applications.
• Previous work experience where attention to detail and personal accountability were critical to success
• Demonstrates good interpersonal skills, is attentive and approachable.
• Maintains a professional and productive relationship with area management and co-workers.
• Must have ability to work as self-starter and handle multiple priorities in a dynamic cross-functional team based environment.