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$84k–$114k/yr
Full-time
bachelor degree
Medical, Dental, Vision, 401(k), FSA/HSA, Life Insurance
Posted 32d ago
~40 hrs/week
Responsibilities
Lead and coach a team of 5-10 technicians to execute cGMP Drug Product Fill/Finish operations and facility start-up. Responsible for validation protocol execution, procedural design, and ensuring safety and quality standards are met.
Requirements
Requires a Bachelor's degree with 2+ years of experience or 5+ years of GMP Manufacturing experience. Must be able to gown into aseptic areas and possess strong organizational and leadership skills.
Full job 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.
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.
We are proud to be an 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. In order to ensure reasonable accommodation for individuals protected by Section 503 of the Rehabilitation Act of 1973, the Vietnam Era Veterans’ Readjustment Assistance Act of 1974, Title I of the Americans with Disabilities Act of 1990, and any other applicable federal, state or local laws, applicants who require reasonable accommodation in the job application process may contact [email protected].
Related keywords
Drug ProductFill/FinishcGMPCQVAutoclavesWashersSingle Use TechnologiesIsolatorLyophilizerCIPVial WashingFDAEMAICH RegulationsSOPMBR
Effective March 17, 2025, The U.S. subsidiary of BeiGene, Ltd. has changed its name to BeOne Medicines USA, Inc. This change comes ahead of our anticipated global rebranding to BeOne Medicines Ltd. and redomiciliation to Switzerland, pending shareholder approval. The new name reflects our commitment to develop innovative medicines and partner with the global community to help as many patients with cancer as possible.
To learn more about BeOne Medicines, please follow our new LinkedIn profile @BeOne Medicines.
Offices: 55 Cambridge Parkway, Suite 700W, Cambridge, MA 02142, US · 55 Challenger Rd, Ridgefield Park, New Jersey 07660, US · 1840 Gateway Drive, 3nd Floor, San Mateo, CA 94404, US · 1900 Powell Street, Suite 500, Emeryville, CA 94608, US · 6A Jianguomenwai Avenue, 22nd Floor, Tower D, Chaoyang District, Beijing, China 100022, CN
How much do Management & Leadership jobs in New Jersey pay?
Based on 6811 listings with disclosed salaries, most management & leadership jobs in New Jersey pay between $75k–$205k per year. Individual offers vary with seniority, company size, and specialization.
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