Supervisor, Drug Product Fill/Finish Operations

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 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.