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Position Title: VP of CMC

    Join LongBio Biopharma. We are looking for high-caliber talent to drive innovation and shape our shared future. Expect full decision-making authority, strategic resources, and rewards that match your impact.

    Send your resume to: hr@longbiopharma.com

Job Responsibilities

1.  In charge of process development（upstream + downstream），clinical supply, QC department，and QA department,

2. responsible for internal technology platform and CMC strategy, establish a full-cycle CMC development and manufacturing system spanning pre-clinical development through commercial launch, to facilitate the smooth delivery of product pipelines.

3. Oversee overall CMC related project management, quality control and quality assurance to support the clinical development of internal projects and commercialization

(1) Cooperate with CDMO partners and take full ownership of end-to-end CMC management for biologic antibody projects, covering process development, technology transfer, manufacturing and batch release.

(2) Develop and implement overall CMC project plans; align resources across CDMOs and internal teams including upstream cell culture, downstream purification, QA, QC and formulation to ensure all key milestones are delivered on time.

(3) Identify technical bottlenecks and compliance risks in CMC activities, lead cross-functional solution formulation and implementation to guarantee on-time project delivery.

4. Manufacturing and Process Management

(1) Organize production operations for upstream cell culture and downstream purification to ensure process consistency as well as compliance with yield and quality specifications.

(2) Manage technology transfer and process scale-up; review batch production records, master batch records and other documentation, and resolve technical issues arising during production.

(3) Drive process optimization, cost reduction and efficiency improvement, and support monitoring and refinement of critical process parameters.

5. Quality System and Compliance Management

(1) Guide the QA team to build and maintain a cGMP quality management system that meets the dual filing requirements of NMPA and FDA (China & US).

(2) Supervise the QC team to complete testing activities for drug substance, drug product, stability studies and analytical method validation, guaranteeing data integrity and accuracy in line with Chinese and US pharmacopoeia as well as regulatory submission standards.

(3) Lead internal and external CMC audits as well as regulatory inspections (including remote assessments) to sustain continuous compliance of manufacturing and quality systems.

6. Support Regulatory related affairs

Coordinate the drafting and review of CMC dossiers (including manufacturing processes, quality control and stability sections for IND/BLA applications) to meet technical requirements from Chinese, US and European regulators. Prepare and respond to regulatory inquiries and support on-site inspections.

7. Team Building and Resource Management

(1) Manage workforce planning, skill training, performance appraisal and talent pipeline development.

(2) Allocate internal manufacturing resources and external CDMO resources, control the CMC budget and improve operational efficiency.

8. Support business development (BD) related affairs including due diligence

Job Requirements

1. Master or above in Bioengineering, Biochemistry, Molecular Biology, Pharmaceutical Sciences or other related disciplines.

2. A minimum of 20 years of CMC working experience in the biopharmaceutical industry.

3. Proven track record as the CMC head/lead for at least 3 late-stage biologic project with dual China-US regulatory filings (IND or BLA).

4. Capable of interpreting and implementing CMC-related regulatory guidelines.

5. Excellent multitasking and risk assessment capabilities, with the ability to balance production timelines, quality compliance and regulatory submission schedules.

6. Fluent written and spoken English.