General Description: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 below, we help get more affordable medicines to more patients around the world.
- 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
BeOne is committed to fair and equitable compensation practices. Actual compensation packages are determined by several factors that are unique to each candidate, including but not limited to job-related skills, depth of experience, certifications, relevant education or training, and specific work location. Packages may vary by location due to differences in the cost of labor. The recruiter can share more about the specific salary range for a preferred location during the hiring process. Please note that the listed range reflects the base salary or hourly range only. Non-Commercial roles are eligible to participate in the annual bonus plan, and Commercial roles are eligible to participate in an incentive compensation plan. All Company employees have the opportunity to own shares of BeOne Medicines Ltd. stock because all employees are eligible for discretionary equity awards and to voluntarily participate in the Employee Stock Purchase Plan. The Company has a comprehensive benefits package that includes Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance, Paid Time Off, and Wellness.
