Manager, Quality Control Chemistry

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:

Manages all Quality Control (QC) Chemistry Laboratory – Capillary Electrophoresis (CE) activities to support GMP manufacturing, testing and release of materials, intermediates, and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Chemistry procedures including but not limited to capillary electrophoresis and supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the CE laboratory.  This position reports to the Senior Manager QC and is located full-time at the Hopewell, NJ site.

Essential Functions of the Job:

• Lead the QC Chemistry (CE) laboratory daily workflow.
• Establish and maintain QC Chemistry (CE) laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.
• Manage QC Chemistry (CE) laboratory routine operations, including but not limited to validation, SOPs, specifications, testing records, personnel training and assessment, scheduling, etc.
• Ensure QC Chemistry (CE) laboratory compliance with Environmental Health and Safety (EHS) standards.
• Ensure timely completion of testing (e.g., In-process control, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results in support of manufacturing operations.
• Review of laboratory test results, ensuring adherence to Good Documentation Practices.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implementation of effective corrective actions and preventive actions (CAPAs).
• Participate in internal and external GMP audits where possible.
• Ensure that the QC Chemistry (CE) laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.
• Expertise in Quality Control (QC) within a Good Manufacturing Practice (GMP) environment, ensuring compliance with industry standards and regulations through hands-on laboratory experience.
• Working knowledge and experience with capillary electrophoretic analytical methods such as reduced and non-reduced CGE, CZE, and cIEF/icIEF, etc.
• Knowledgeable with USP/EP and cGMP/EU GMP regulations.
• Familiar with instrument and equipment validation.
• Expert knowledge of quality control principles, practices and standards for the biopharmaceutical industry.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Strong leadership/team management skills and experience.
• Manage, motivate, coach and mentor direct reports.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical, problem-solving ability, with excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Excellent project management skills.
• Hands-on approach, with a ‘can do’ attitude.
• Ability to prioritize, demonstrating good time management skills.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.
• Interacts with all levels of BeOne employees
• Undertake any other duties as required

Supervisory Responsibilities:  

• Manage direct reports from QC Chemistry (CE) laboratory
• 2+ years of managerial experience directly managing people required
• Leadership experience leading teams, projects, programs or directing the allocation of resources.

Computer Skills:

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Ability to work on a computer for extended periods of time

Travel:

• Must be willing to travel approximately 10%

Education Required:

• Bachelor’s Degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline with 5+ years of GMP testing using capillary electrophoresis techniques in an FDA-regulated biotechnology, pharmaceutical company is required.
• Bachelor’s degree in Chemistry, Biology, Molecular Biology, Biotechnology, Biochemistry, or related scientific discipline preferred.
• Master’s degree and 4+ years of relative experience preferred.

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

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].