About the Company
We are a leading biopharmaceutical company dedicated to advancing healthcare through innovative solutions and a commitment to quality and integrity.
About the Role
The role involves leading and managing the Analytical R&D team, coordinating project timelines, and ensuring the successful execution of project plans.
Responsibilities
- Lead and manage the Analytical R&D team.
- Oversee analytical method development, stability studies, method validation, and method transfer to support process development and product release testing for R&D projects.
- Supervise routine analytical testing activities supporting upstream and downstream development teams.
- Coordinate daily operations within the analytical department and across functions; review experimental data and promptly resolve technical issues arising during studies.
- Maintain effective communication with CRO/CDMO partners and facilitate project progress in a timely and efficient manner.
- Provide oversight and guidance to analysts on experimental execution and compliance with laboratory standards, ensuring data integrity, accuracy, and completeness.
- Manage laboratory operations, including equipment maintenance and instrument lifecycle management.
- Lead talent development within the team, including training programs and performance evaluation systems.
- Prepare and/or review regulatory submission documents and raw data in compliance with drug registration requirements; support regulatory filings and on-site inspections.
Qualifications
- Master’s degree with at least 10 years of experience, or PhD with at least 8 years of experience in pharmaceutical analysis, biotechnology, biochemistry, analytical chemistry, or related fields.
- Proven experience in a large biopharmaceutical company, with a minimum of 5 years in analytical team leadership/management roles.
Required Skills
- Hands-on experience in analytical characterization platform management, with a strong foundation in biomolecular mass spectrometry and quality characterization.
- Expertise in protein characterization strategies and method development, including but not limited to: primary structure, post-translational modifications (PTMs), disulfide bonds, higher-order structure, biological activity, and heterogeneity.
- In-depth knowledge of characterization technologies (including but not limited to HPLC, LC-MS, CE, iCIEF, DSC, CD, BLI), with the ability to troubleshoot technical challenges and ensure robust platform operations.
- Strong expertise in analytical method development, optimization, transfer, qualification, and validation, with the ability to effectively manage analytical timelines across projects.
- Deep understanding of analytical methods for antibody/recombinant protein therapeutics, including assays for potency, binding activity, biological activity, HCP, Protein A, residual DNA, and other routine biochemical quality attributes.
- Solid understanding of regulatory requirements and guidelines from NMPA, FDA, and ICH, with hands-on experience in multiple IND and BLA submissions.
- Familiarity with relevant regulations and standards, including cGMP, ICH guidelines, Chinese Pharmacopoeia, and USP.
- Strong sense of responsibility, with excellent communication, coordination, and teamwork skills, including proficiency in both written and spoken English.
Preferred Skills
- Basic knowledge of GMP is preferred.
Pay range and compensation package
Competitive salary based on experience and qualifications.
Equal Opportunity Statement
We are committed to diversity and inclusivity in our hiring practices and encourage applications from all qualified individuals.