Supervisor, Drug Product Fill/Finish Operations

BeiGene•Hopewell, VA

3d•Onsite

About The Position

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

Requirements

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
Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
Health authority inspections (FDA, EMA, ICH regulations and guidelines).
Execution and optimization of controlled procedures.
Technical and business writing.
Business process development.

Nice To Haves

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

Responsibilities

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
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