<p>Job Title - Lead Bioprocessing Associate, MFG</p> <p>Work Location - Worchester, MA</p> <p>Job Summary</p> <p>The primary responsibility of this role will be to support and deliver on process and equipment operation activities during manufacturing operations.? The Lead Bioprocessing Associate will be a key member of the Worcester Manufacturing team. They will work independently and in a team environment to contribute to the operation and overall successful start-up and transition to GMP operations. This includes, but is not limited to, movement and cleaning/disinfection of materials and equipment, operating manufacturing systems for engineering/validation testing and/or manufacture of commercial GMP products, documenting GMP data via written and electronic systems, developing and adhering to standard operating procedures and developing and delivering training for operation of manufacturing systems and processes. A key responsibility of this role will be to coach and mentor Technicians (Bioprocessing Associates). Detailed knowledge of the process will be vital to ensure optimum process operations, as well as a high level of understanding of cGMP requirements.</p> <p>Responsibilities</p> <ul> <li>Responsible for execution of daily cGMP manufacturing operations and/or operations tasks required for facility start up. </li><li>Collaborates with manufacturing team members to organize and align daily tasks within the shift/team. </li><li>Participates in the organization daily activities and work with Bioprocessing Associates in executing those activities in a safe, compliant, and efficient manner to maintain production schedules. </li><li>Act as designee for the Supervisor in their absence. Duties in this situation would include but are not limited to attending and leading meetings, time off coverage, use escalation process, act as a point of contact for Bioprocessing Associates. </li><li>Understands and executes aseptic operational techniques, as well as facility start-up tasks. </li><li>Perform all core production tasks in Upstream manufacturing, Downstream manufacturing, media/buffer solution preparation, or manufacturing support areas, as well as all ancillary tasks. </li><li>Lead and actively participate in shift handovers. Liaise with manufacturing leadership regarding issues which may arise from the production area, including highlighting process bottlenecks. </li><li>Act as SME on all applicable manufacturing equipment and procedures, participating in audits/inspections as needed. </li><li>Write, review and update Standard Operating Procedures (SOPs), On the Job Training (OJTs), Production Batch Records (PBRs), Logbooks, Training Competencies and Work Instructions. </li><li>Carry out all production operations in the assigned area as directed by the relevant SOPs, PBRs and Manufacturing Execution Systems (MES). </li><li>Perform initial troubleshooting of issues identified during routine operations. Adhering to Right First Time (RFT) principals at all times. </li><li>Create and lead training for SOPs, process execution and equipment operation. Support the development of training matrices and ensure compliance with training requirements. </li><li>Support deviation investigations through interactions with quality assurance and investigators to document immediate actions taken and root cause analysis. </li><li>Actively participate in facility, equipment start-up and validation activities. </li><li>Provide input on equipment installation, operation and troubleshooting to support introduction of new products and processes. </li><li>Work with cross functional teams to facilitate the development and validation of the Biologics manufacturing facility. </li><li>Lead Bioprocessing Associate will also develop and demonstrate individual skills as subject matter experts and are required to display technical leadership by acting as 'Champion' to drive improvements and excellence within specific aspects of the manufacturing operation. </li><li>Assist in driving and maintaining a safety orientated Culture, cGMP/GDP compliant work environment at all times. </li><li>Liaise with other groups and individuals to ensure planning of tasks is effective and linked into the manufacturing process plan. </li><li>Use Lean Tools as part of daily operations (Standard Work, 5S, TPM, Method 1, 2 etc.) to optimize efficiency and drive the culture of Continuous Improvement (CI) and Zero Defects. </li><li>Support equipment design and risk assessments as per requirements. </li><li>Support Operations team to consistently deliver on specific area Key Performance Indicators (KPIs), e.g. Safety, Quality, Schedule delivery, EHS metrics, Production Plan, Overall Equipment Effectiveness (OEE), compliance and team training. </li><li>Provide assistance and/or support for maintenance, engineering, quality or other colleagues, as requested. </li><li>Due to the start-up nature of the project, there will be an expectation for flexibility and an ability to take on varied tasks at short notice not covered extensively within this job description. </li><li>Conduct all activities that are in accordance with Company policies & SOPs, WuXi Biologics values, & global regulatory guidelines (including cGMP/cGLP/cGCP), environmental guidelines, as appropriate, etc.? Advise management of non-conformance issues. </li><li>Identify process and method gaps and highlight opportunities for continuous improvement (CI). </li><li>Shift work is required.?The shift pattern may be varied according to business requirements and may require off-shift, weekend or holiday work. </li><li>Identify and manage equipment training gaps and requirements. </li><li>Perform all duties in accordance with GMP requirements, SOPs and established controlled documents and systems. </li><li>Will be flexible to take on additional tasks and responsibilities at the discretion of leadership. </li><li>Will act as a role model for the Manufacturing function and also the wider organization in adherence to the WuXi Biologics corporate core values and PROUD culture. </li></ul> <p>Qualifications</p> <ul> <li>HS Diploma or equivalent required. Advanced education in a biotechnology certificate program or BS/BA in science related field or combination of relevant Experience & Education preferred. </li><li>3-4 years cGMP commercial operations experience with 2+ years direct experience in biologics drug substance manufacturing. </li><li>Requires understanding of scientific principles, operational aspects of production equipment and automation control </li><li>Demonstrated experience of working in a cGMP environment is essential </li><li>Strong demonstrated knowledge in biologics manufacturing is essential </li><li>Comprehensive knowledge and experience of relevant cGMP, safety and environmental regulations within the biopharmaceutical industry </li><li>Previous experience acting as supervisor or designee is preferred </li><li>Demonstrated experience as an SME in a biopharmaceutical operation is preferred </li><li>Experience in coordinating shift activities and escalation of issues to ensure all manufacturing processes are adhered to is preferred </li><li>Demonstrated experience with project management and execution is an advantage </li><li>Good level of knowledge and execution of validation protocols is an advantage </li><li>Experience in Lean, 6 Sigma tools in standard work and 5S are an advantage </li><li>Demonstrated career progression is desirable </li></ul> <p>Behavioral Competencies</p> <ul> <li>Self-motivated with excellent communication and interpersonal skills </li><li>High level of adaptability, working in a fast-paced environment and champion of change </li><li>Ability to positively influence and work well with others </li><li>Show leadership and support to junior team members </li><li>Ability to troubleshoot, with strong analytical skills </li><li>Comfortable making risk-based decisions </li><li>Results driven and a proven record of being a high achiever </li></ul> <p>Physical Requirements</p> <ul> <li>Must be able to work in an office environment with minimal noise conditions </li><li>Must be able to work in Lab setting with Biohazards / Various Chemicals </li><li>Must be able to wear appropriate PPE </li><li>Must be able to work in environment with variable noise levels </li><li>Ability to Stand / Sit / Walk for long periods of time </li><li>Ability to Lift / Push / Pull 25 lbs routinely </li><li>Ability to crouch, bend, twist, and reach </li><li>Clarity of vision and have the ability to identify and distinguish colors </li><li>Must be able to perform activities with repetitive motions </li><li>Ability to climb Ladders / Stairs / Scaffolding </li><li>Ability to work in variable temperatures from high to freezing </li></ul> <p>The anticipated base pay range for this position is $40-50hr</p> <p>WuXi Biologics is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability</p>