Director, Quality Analytical Technical Lead, Small Molecule

BeOne Medicines; United States; On-site; USD 168,000 - 228,000; Full time

Benefits offered by this job

Medical, Dental, Vision

Equity awards

Employee Stock Purchase Plan

Bonus eligible

Job summary

BeOne Medicines seeks an Analytical Technical Lead to own analytical lifecycle management for commercial products across US, EU, China, Australia and Canada. You will provide governance for DS/DP analyses, drive method validation, stability, and regulatory readiness with internal QC sites, external labs, and CMOs.

The role requires 10+ years in biopharma, advanced degrees, and proven leadership in GMP QC; travel up to 20%.

Qualifications

• Experience in GMP QC and analytical sciences for small molecules.
• Strong knowledge of method validation/verification and stability trends.
• Experience with data integrity and regulatory submissions.

Responsibilities

• Act as global analytical PoC for commercial products and lead investigations.
• Oversee analytical control strategy, specification governance, and lifecycle management.
• Provide regulatory-facing analytical documentation and support RoW filings.

Skills

GMP QC leadership

Analytical sciences knowledge

Method validation/verification

Stability trends & statistics

Data integrity

Education

Bachelor’s degree and 10+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility

Master’s degree and 7+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility

Doctoral Degree and 5+ years of Biopharmaceutical experience with significant commercial lifecycle responsibility

Tools

HPLC/UPLC

GC

Dissolution

Residual solvents

Elemental impurities

Genotox impurities

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 Analytical Technical Lead (ATL) is the single global point of contact and accountable owner for analytical lifecycle management of assigned commercial products across major markets (US, EU, China, Australia, Canada) and supports Rest of World (RoW) expansion and post-approval maintenance.
• At Director level, this role is responsible for making risk-based, inspection-defensible decisions on methods, specifications, stability, and analytical investigations across a distributed internal/external QC network for small molecule products.
• This leader ensures the analytical control strategy remains robust over the product lifecycle, drives harmonization, and enables reliable supply while meeting GMP, pharmacopeial, and regulatory expectations.
• The Analytical Technical Lead (ATL) may own relevant global business processes, ensure compliance and efficiency.

Essential Functions Of The Job

• Global Analytical Point of Contact (PoC) for Approved Commercial Products
• Act as the global PoC for all analytical-related matters for assigned products, to ensure analytical readiness.
• Provide governance and technical leadership for analytical topics spanning drug substance (DS), drug product (DP), and critical raw materials/reagents as applicable.
• Translate global product strategy into aligned expectations and deliverables for internal QC sites, external QC labs/CMOs, AST, and MST.
• Analytical Lifecycle Management: Changes, Deviations, and Investigations
• Lead and approve strategy for analytical investigations and performance issues (OOS/OOT/OOE, atypical results, invalidations), ensuring scientifically sound root cause analysis and effective CAPA, including method optimization.
• Drive analytical change control impact assessments and execution plans, including method updates, revalidation/verification, reference standard changes, and instrument/software upgrades.
• Own escalation management for supply-critical analytical events; align actions with Quality, Regulatory, and Supply Chain.
• Global Business Process & Knowledge Owner: Methods, Specifications, Stability, Retest/Shelf Life
• Serve as global business process and knowledge owner for:
• • Commercial analytical method lifecycle (validation/verification strategy, transfers, periodic review, trending, method robustness improvements)
  • Global specifications governance (release and stability), including harmonization and lifecycle updates
  • Stability program ownership (protocol strategy, commitments, pull schedules, trending, annual review narratives)
  • Retest period/shelf-life governance (extensions, commitments, labeling impacts, country-specific constraints)
• Take over “submission-ready” documentation sources from development: analytical control strategy, method history, validation packages, specification rationale, and stability trend narratives.
• Ensure defensible alignment between analytical control strategy and product risk profile (CQAs/CPPs), including small-molecule impurity control.
• Regulatory Support: RoW Filings and Post-Approval Variations
• Provide analytical SME leadership for global regulatory submissions relevant to QC:
• • RoW filings (Module 3 analytical sections, stability commitments, method/spec alignment)
  • Post-approval changes (variations, supplements), including comparability narratives and analytical bridging
• Partner with Regulatory CMC on health authority interactions and responses related to analytical controls, stability trends, and specification justification.
• Partner and Network Oversight (Internal QC and External Labs/CMOs)
• Provide governance for external QC networks: align expectations, metrics, investigation quality, and issue escalation pathways (with ESQ as needed).
• Contribute to audits/inspections as product analytical SME; ensure inspection readiness for assigned products and analytical systems.
• Influence lab capacity planning and capability upgrades with a risk-based view.

Supervisory Responsibilities

• N/A

Education

• Bachelor’s degree and 10+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience required
• Master’s degree and 7+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience preferred
• Doctoral Degree and 5+ years of Biopharmaceutical with significant commercial lifecycle responsibility experience desired

Computer Skills

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

Other Qualifications

Experience

• Demonstrated leadership in GMP QC and/or analytical sciences for:
• • Small molecule methods (HPLC/UPLC, GC, dissolution, residual solvents, elemental impurities, genotox impurities as applicable)
• Strong working knowledge of method validation/verification, stability trends and statistical evaluation, specification lifecycle management, and data integrity.

Leadership Competencies

• Ability to lead through influence in a matrix organization; strong stakeholder management and negotiation skills.
• Strong technical writing and ability to deliver inspection-defensible narratives.
• Program and risk management mindset; ability to prioritize in supply-constrained environments.

Travel: Up to 20%

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: $168,000.00 - $228,000.00 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].