(Associate) Director, Analytical Technologies

Role Overview
This is a high-impact technical leadership role designed for an experience analytical scientist with a proven track record of working in a cGMP environment with deep expertise in ADC, monoclonal antibodies, bispecific antibodies, recombinant proteins, and fusion proteins, etc. As QC’s subject matter expert (SME), this position will serve as the technical bridge between QC /AD and between QC/global clients, leading complex investigations, and driving technical client communications.
Key Responsibilities
1. Technical Leadership & Complex Investigations (50%)
Serve as the technical lead for OOS/OOT/OOE investigations involving product-specific CQAs for both DS/DP release and stability testing.
Provide deep technical input for troubleshooting for any atypical results investigation, including method performance issues (during method transfer and post-transfer), instrument anomalies, and product-related degradation pathways.
For ADC programs: Lead investigation of DAR (drug-to-antibody ratio), unconjugated antibody, aggregation post-conjugation, and payload-related impurity issues, and stability related events.
Complex problem-solving capabilities: Ability to evaluate the totality of data and integrate data from multiple sources to identify root causes that are not immediately obvious. Comfortable leading investigations where the path forward is unclear.
2. Client-Facing & Regulatory Communication (30%)
Lead technical presentations (data packages, method validation summaries, investigation reports,etc) for global pharma clients (US/EU) in English, with the ability to adapt communication style for different audiences.
Draft and defend responses to client audit findings as well as regulatory authorities inspection observations.
Act as the primary QC technical spokesperson during client audits and regulatory inspections. This includes the ability to think on your feet during live questioning and respond to challenging technical inquiries with poise and accuracy.
Complex communication capabilities: Ability to explain a major OOS or deviation event related to testing to oversea client in a way that builds trust rather than causing panic – balancing full transparency with scientific rationale and a clear path forward. Comfortable leading difficult conversations where bad news must be delivered constructively.
3. Cross-Functional Technical Integration (20%)
Partner with AD to ensure seamless method transfer from development to QC.
Provide technical oversight for data integrity (21 CFR Part 11, audit trail review) of analytical computerized systems (e.g., Empower, SoftMax Pro, etc).
Support comparability studies (pre- and post-process change, site transfer) with robust statistical and analytical analysis.
Qualifications
Education:
Master‘s degree (required) or PhD (strongly preferred) in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences, or related field from oversea university (US preferred).
Experience:
Minimum 5+ years (PhD) or 8+ years (Master) of hands-on analytical experience in biologics CMC within a multinational corporation (MNC), oversea working experience is strongly preferred.
Proven track record of working in an English-speaking work environment (US/EU) – must demonstrate ability to lead scientific discussions in English without language barriers.