Key Responsibilities

Strategic Leadership & Management:

• Provide strategic direction and day-to-day leadership to the Formulation Development team, fostering a culture of innovation, quality, and accountability.
• Develop and manage the department’s resource allocation and maximize people’s work efficiency and the team’s project handling capability and capacity.
• Mentor and develop top scientific talent, ensuring high levels of engagement and performance.
• Define and implement best practices, workflows, knowledge management and long-term scientific strategies.

Technical & Scientific Excellence:

• Oversee the design and execution of comprehensive formulation development programs for complex biologics, including mAbs, multispecifics, and novel modalities.
• Champion the development of high-concentration liquid formulations, addressing key challenges of viscosity, stability, and manufacturability.
• Drive the development, optimization, and scale-up of lyophilization processes for parenteral products.
• Lead activities for drug products in pre-filled syringes and other delivery systems, including compatibility and process studies.
• Spearhead drug developability and stability assessment, and biophysical characterization strategies to de-risk candidate molecules and guide formulation design.
• Assist successful technology transfer of drug product processes to GMP production
• Act as the ultimate scientific authority, reviewing and approving technical protocols, reports, and regulatory submissions.

Cross-Functional Collaboration & Compliance:

• Serve as the primary subject matter expert (SME) for drug product development on client projects and internal governance teams.
• Collaborate seamlessly with Analytical Development, Process Development, Manufacturing Science and Technology, Quality, and Manufacturing teams to ensure integrated project execution.
• Ensure GMP/registration related activities are performed in compliance with all relevant regulatory requirements (NMPA, FDA, EMA, etc.).
• Represent the department during client audits and help regulatory inspections.

Qualifications & Experience Essential:

• PhD in Pharmaceutics, Biochemistry, Chemical Engineering, or a related field with 5+ years of industry experience, OR a Master's degree with 8+ years of proven experience.
• Extensive, hands-on expertise in biologics formulation development, with a deep mastery of:
• High-concentration liquid protein formulations.
• Lyophilization development and scale-up.
• Drug product development for pre-filled syringes.
• A wide range of biophysical characterization techniques (e.g., DSC, DLS, CD, MFI).
• Process characterization
• A minimum of 3 years of direct line management and technical leadership experience, with a proven ability to lead, motivate, and develop a high-performing team.
• Comprehensive understanding of GMP requirements for clinical and commercial drug product manufacturing.
• Direct experience with tech transfer to fill/finish operations.
• Fluent English with exceptional written and verbal communication skills, demonstrated by a history of authoring technical and regulatory documents and effectively engaging with clients.

Desirable:

• Prior experience within a CDMO or contract research environment.
• Experience interacting with health authorities and supporting regulatory filings (IND/IMPD/BLA).
• Strong business acumen and client relationship management skills.