Senior Manager, Analytical Manufacturing Science and Technology

BeiGene; Hopewell (NJ); On-site; USD 139,000 - 184,000; Full time

Job summary

BeOne Medicines Ltd. seeks a Senior Manager, Analytical MST to lead the MST Analytical Laboratory at Hopewell, NJ.

You will oversee method transfers, drive analytical readiness for new products, and manage GMP documentation and regulatory submissions in a fast-paced biopharmaceutical environment. Ideal candidates bring extensive biologics analytics experience, strong leadership, and a track record of cross-functional collaboration with Manufacturing Operations, QA, and Regulatory Affairs.

Qualifications

• Required: Demonstrated expertise in biologics analytical methods and protein product quality attributes; analytical method transfer.
• 5 years of direct people-management or substantial leadership of analytical teams, projects, or programs.
• Preferred: Experience with regulatory submissions, laboratory start-up or capability expansion.

Responsibilities

• Provide strategic and technical oversight for MST Analytical Laboratory capabilities supporting monoclonal and bispecific antibody drug substance and drug product manufacturing.
• Lead analytical method transfers of physicochemical, potency, and structural characterization methods to Hopewell Quality Control laboratories, including gap assessments, transfer strategy, protocol execution, acceptance criteria, and final reports.
• Support analytical readiness for new product introductions and lifecycle projects by defining deliverables, risks, resources, dependencies, and completion criteria aligned with approved project timelines.
• Perform or direct laboratory testing, as needed, using technologies including high-performance and ultra-high-performance liquid chromatography (HPLC/UHPLC) and capillary electrophoresis (CE).
• Author, review, and approve GMP documentation, including analytical transfer plans, protocols, reports, study plans, deviations, corrective and preventive actions, change controls, and standard operating procedures.
• Support analytical content for global regulatory submissions, supplements, health authority responses, commitments, and inspection-readiness activities.

Education

Bachelor’s degree in analytical chemistry/biochemistry/pharmaceutical sciences

Master’s degree in related discipline

Tools

MS Office

Statistical software (JMP, Minitab)

LIMS

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

• The Senior Manager, Analytical Manufacturing Science and Technology (MST), provides technical leadership and project management for analytical method transfers to Hopewell QC laboratories. The role is also accountable for overseeing the MST Analytical Laboratory and its personnel, and instruments.

Essential Functions of the Job

• Provide strategic and technical oversight for MST Analytical Laboratory capabilities supporting monoclonal and bispecific antibody drug substance and drug product manufacturing.

• Lead analytical method transfers of physicochemical, potency, and structural characterization methods to Hopewell Quality Control laboratories, including gap assessments, transfer strategy, protocol execution, acceptance criteria, and final reports.

• Support analytical readiness for new product introductions and lifecycle projects by defining deliverables, risks, resources, dependencies, and completion criteria aligned with approved project timelines.

• Perform or direct laboratory testing, as needed, using technologies including high-performance and ultra-high-performance liquid chromatography (HPLC/UHPLC) and capillary electrophoresis (CE).

• Provide scientific leadership for method qualification and validation, analytical comparability, method performance trending, and complex OOS, OOT, and investigations.

• Author, review, and approve GMP documentation, including analytical transfer plans, protocols, reports, study plans, deviations, corrective and preventive actions, change controls, and standard operating procedures.

• Support analytical content for global regulatory submissions, supplements, health authority responses, commitments, and inspection-readiness activities.

• Establish metrics and governance for transfer progress, laboratory readiness, method performance, investigation closure, and on-time delivery; elevate risks and implement mitigation plans.

Supervisory Responsibilities

• Manage and develop direct report(s), including workforce planning, hiring, onboarding, objective setting, coaching, performance management, succession planning, and technical capability development.

• Build an analytical team capable of supporting technology transfer, process development and small scale studies.

• Lead cross-functional collaboration with Manufacturing Operations, Quality Assurance, Quality Control, CMC, Regulatory Affairs, Process Development, and external partners.
  

Computer Skills

• Strong PC literacy required; MS Office skills (Outlook, Word, Excel, PowerPoint).
• Statistical software application experience preferred (JMP, minitab, etc)
• Experience with LIMS (Laboratory Information Management System ) preferred.

Education

• Bachelor’s degree in analytical chemistry, biochemistry, pharmaceutical sciences, or a related scientific discipline with 7+ years of relevant biopharmaceutical experience required.
• Master’s degree in a related discipline with 5+ years of relevant biopharmaceutical experience preferred.

Other Qualifications

• Required: Demonstrated expertise in biologics analytical methods and protein product quality attributes; analytical method transfer.

• 5 years of direct people-management or substantial leadership of analytical teams, projects, or programs.

• Preferred: Experience with regulatory submissions, laboratory start-up or capability expansion.
  

Travel: Up to 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

Salary Range: $138,800.00 - $183,800.00

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].