Manager, QC Biochemistry (Hopewell, NJ)

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:

Supervises staff and executes QC Biochemistry laboratory activities to support GMP manufacturing, testing and release of material, intermediates and finished products under FDA/EU regulations, applicable International Regulations, BeOne processes and procedures. Establishes and implements QC Biochemistry procedures and supports regulatory compliance inspections. Ensures efficient and effective day to day operations of the Biochemistry laboratory.

Essential Functions of the job:

• Lead the QC Biochemistry GMP laboratory through late phase activities.

• Oversee QC Biochemistry laboratory related quality systems to ensure conformance with regulations and BeOne Global quality standards.

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.

• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and, scheduling, etc.

• Execute laboratory bench work for analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as required.

• Ensure Biochemistry laboratory compliance with Environmental Health and Safety (EHS) standards.

• Ensure timely completion of testing (e.g., in-process, DS release, DP release, and stability testing) to ensure timely generation and reporting of test results In support of manufacturing operations.

• 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.

• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.

• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.

• Manage, motivate, coach and mentor direct reports.

• Undertake any other duties as required.

Core Competencies, Knowledge, and Skill Requirements:

• Scientific degree (ideally in Biochemistry, molecular biology, biotechnology or related).

• Minimum of 5-7 years working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company with progressive levels of responsibility are required.

• Working knowledge and experience with Biochemistry analytical methods such as Potency assays, Binding ELISA, Cell Culture, Residual Host Cell Protein(HCP), Residual DNA as well as instruments such Incubators, Biosafety Cabinets, Plate Washers, and Microplate Readers, etc.

• Knowledgeable with USP/EP and cGMP/EU GMP regulations.

• Direct experience in a GMP quality control lab is a must.

• 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.

• Credible and confident communicator (written and verbal) at all levels.

• Strong analytical and problem-solving ability.

• Excellent project management skills.

• 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.

Supervisory Responsibilities:  

• Supervise a highly efficient QC Biochemistry team. Identify and develop key talents.

• Manage QC Biochemistry laboratory routine operations, including but not limited to validation, SOP revisions, specification updates, testing records, personnel training and scheduling, etc.

• Manage QC Biochemistry method transfers and method validation activities, including transfer/validation strategy and approval of protocols and reports.

• Ensure that the QC Biochemistry laboratory meets or improves on budget, cost, volume, and efficiency targets (KPIs) in line with business objectives.

• Manage, motivate, coach and mentor direct reports.

Computer Skills:   

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).

• Ability to work on a computer for extended periods of time.

Education Required:

Bachelor’s Degree required in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 5-7 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are required.

Master’s degree in Chemistry, Biochemistry, or Biotechnology related scientific discipline and 4-5 years of working experience and 2 years managing laboratory analysts in an FDA-regulated biotechnology, pharmaceutical company are preferred.

Travel:   

• Must be willing to travel approximately 10%.

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].