Supervisor, Drug Product Fill/Finish Operations

Benefits

Additional Information

BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. General Description: BeOne continues to grow at a rapid pace with challenging and exciting opportunities for experienced professionals. When considering candidates, we look for scientific and business professionals who are highly motivated, collaborative, and most importantly, share our passionate interest in fighting cancer. This position reports directly to the Manager of Drug Product and requires effective leadership, coaching and performance management of 5-10 technicians. This position will be responsible for facility start-up and execution of cGMP Drug Product Fill/Finish operations. The Drug Product Supervisor will be responsible for actively directing and engaging in work to support the following two phases of the Hopewell manufacturing facility: Facility start-up and CQV execution High volume reliable cGMP Manufacturing Preferred Skills/Experience Facility Start- Up Commissioning, Qualification & Validation Equipment and/or Process Design Autoclaves and Washers Single Use Technologies Inspection and Packaging Quality Risk Assessments Health Authority Interaction/Audits Resource Modeling OE and/or LEAN Methodologies Distributed Control system / Control Systems Deviation Assessments / Investigations SAP, LIMS, CMMS, Veeva Essential Functions of the Job: Support all site validation protocol execution and report generation Equipment start-up, troubleshoot, and perform acceptance testing Procedural design (SOP's, MBR's, etc.) Solution preparation, Thaw and Pooling activities Familiar with Vial Washing, Tunnel, and Sterile Filling in an Isolator Integrity testing CIP and Lyophilizer Visual Inspection Sampling Training technicians on process Problem solving Promotion of Safety in all facets of work Good Documentation Practices Equipment and process troubleshooting Delivering technical presentations Support drafting and executing change records Batch Record Review Initiate and review deviations Supervisory Responsibilities: Strategic and tactical planning with ability to convey business relevance to team Ability to translate strategy into actionable goals and expectations for team members Consistently delivers tangible business that support organizational objectives via self and direct reports Leading, directing, coaching/developing, and providing timely feedback to direct reports Planning and managing day -to-day activities, including staff availability and task load Writing and delivering effective performance appraisals Consistently receives and provides feedback thoughtfully Planning and managing day-to-day activities, including resources and task loading Self-directed leadership within both predictable and ambiguous work environments Deviations, assessments, investigations & CAPA's Inclusive and cross-functional collaboration with all levels Ability to cultivate culture of continuous improvement and right first-time quality Thoughtfully escalates issues/concerns in a timely manner as appropriate Project management and working through competing priorities Recruiting, interviewing, and selecting key talent Education / Experience Required: Bachelor's degree and 2+ years OR 5+ years of GMP Manufacturing experience required Demonstrated ability to successfully gown into aseptic manufacturing areas Excellent organization and time-management skills required Must be able to manage heavy workload and aggressive timelines in a timely manner, prioritize and work under pressure Strong work ethic, Positive Attitude, Time Management, Problem Solving, Team Player, Self-Confidence & Ability to Accept & apply Lessons Learned as needed Works with a sense of urgency, while engaging and listening to experts Ability to work in a fast-paced environment while demonstrating excellent time management and organization skills Strong organizational skills with the proven ability to prioritize Must be dependable and punctual Proficient in the use of standard Microsoft Office software products, including Excel, Outlook, Word Must be flexible to work 1st or 2nd shift with holidays, weekends and overtime as per business needs Customer/Client Focus Computer Skills: Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint). Other Qualifications: Health authority inspections (FDA, EMA, ICH regulations and guidelines). Execution and optimization of controlled procedures. Technical and business writing. Business process development. Travel: International and domestic - periodically Global Competencies When we exhibit our values of Patients First, Driving Excellence, Bold Ingenuity and Collaborative Spirit, through our twelve global competencies bel

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