Senior Analyst, QC Chemistry

Regulatory Jobs; Hopewell (NJ); Presencial; USD 91.000 - 126.000; Jornada completa

Ventajas ofrecidas por este puesto de trabajo

Medical insurance

401(k)

Paid Time Off

Equity awards

Employee Stock Purchase Plan

Descripción de la vacante

BeOne Medicines Ltd. in Hopewell, NJ is seeking a QC Chemistry professional to perform routine and non-routine testing using HPLC/UPLC and other techniques. You will review analytical data to ensure timely, compliant results for in-process, release, and stability testing supporting large molecule manufacturing.

The role includes CAPA implementation, method transfer, and routine instrument maintenance. The position requires a Bachelor's degree in Chemistry/Biochemistry/Biotechnology and at least

Formación

• Bachelor’s degree in Chemistry, Biochemistry or Biotechnology, plus 4+ years in FDA-regulated biotech/pharma.
• Strong GMP knowledge and experience with regulatory inspections.
• Impressive track record in a similar role with leadership experience.

Responsabilidades

• Perform routine and non-routine QC testing using HPLC, UPLC, UV-Vis and related methods.
• Review, interpret, and report analytical data per GMP and internal procedures.
• Investigate OOS events, discrepancies, lab errors, and equipment failures.
• Implement CAPAs and participate in transfer and validation activities.
• Support instrument qualification, SOPs, records, and maintenance.
• Train junior analysts and new hires on instrumentation and GMP practices.

Conocimientos

Leadership

Analytical Thinking

Communication

Problem Solving

Time Management

Educación

Bachelor’s or above in Chemistry/Biochemistry/Biotechnology

Herramientas

Waters Empower Chromatography Data System

Descripción del empleo

General Description:

Perform QC Chemistry laboratory 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 and supports regulatory compliance inspections. Ensures efficient and effective day-to-day operations of the Chemistry laboratory. This position reports to the QC Sr. Manager and is located full-time at the Hopewell, NJ site.

Essential Functions of the Job:

• Perform routine and non-routine testing using HPLC, UPLC, UV-Vis, capillary electrophoresis, and other techniques (PS-20, HPLC-SEC, TOC, Conductivity, CZE, etc.) in the QC Chemistry and Raw Materials laboratory to ensure timely and compliant generation and reporting of in-process, release, and stability test results in support of large molecule manufacturing operations.
• Review, interpret, and report analytical data in accordance with GMP regulations and internal procedures.
• Ensure appropriate investigation of OOS events, discrepancies, lab errors, and equipment failures.
• Implement corrective actions and preventive actions (CAPAs).
• Participate in transfer and method validation activities, including protocol preparation, protocol execution and report preparation.
• Support routine operations, including but not limited to instrument qualification and maintenance, SOP generation and revision, test record keeping, etc.
• Maintain equipment in a qualified and calibrated state, coordinating with metrology or vendors as needed.
• Manage inventory of reagents and supplies for the laboratory.
• Participate in internal and external GMP audits and inspections, as needed.
• Train other junior level analysts and new hires on instrumentation, GMP practices, and data analysis.
• Serving as subject matter expert in one or more areas of required testing.
• Undertake other duties as required.

Supervisory Responsibilities:

• Bachelor’s or above in Chemistry, Biochemistry, or Biotechnology related scientific discipline.
• Minimum of 4+ years of working experience in an FDA-regulated biotechnology, pharmaceutical company are required.
• Familiar with Waters Empower Chromatography Data System.
• Familiar with instrument and equipment validation. Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level. Working knowledge with USP/EP and cGMP/EU GMP regulations.
• Impressive, demonstrable track record and skills/experience gained within a similar position(s), at a similar level.
• Strong leadership/team management skills and experience.
• Credible and confident communicator (written and verbal) at all levels.
• Strong analytical and problem-solving ability.
• Hands-on approach, with a 'can do' attitude.
• Ability to prioritize, demonstrating good time management skills.
• Excellent attention to detail, with the ability to work accurately in a busy and demanding environment.
• Self-motivated, with the ability to work proactively using own initiative.
• Committed to learning and development.

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%

Global Competencies

• Fosters Teamwork
• Provides and Solicits Honest and Actionable Feedback
• Self-Awareness
• Acts Inclusively
• Demonstrates InitiativeEntrepreneurial Mindset
• Continuous Learning
• Embraces Change
• Results-Oriented
• Analytical Thinking/Data Analysis
• Financial Excellence
• Communicates with Clarity

Salary Range: $90,900.00 - $125,900.00 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 [e-mail].