Supervisor, Drug Product Fill/Finish Operations

About the role

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.

Responsibilities

• Facility start-up and CQV execution
• High volume reliable cGMP Manufacturing
• 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

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
• 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

• 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
• Absolutely must be able 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

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
• Techical and business writing
• Business process development

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates Initiative
• Entrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range

$83,500.00 - $113,500.00 annually

Benefits

• Medical
• Dental
• Vision
• 401(k)
• FSA/HSA
• Life Insurance
• Paid Time Off
• Wellness

Equal Opportunity Employer

BeOne does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, disability, national origin, veteran status or any other basis covered by appropriate law. All employment is decided on the basis of qualifications, merit, and business need.