news

Position Title: Director of Manufacturing & Process Technology

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. Comprehend and execute the company’s process development strategy and project objectives. Plan and deliver CMC process development, technology transfer, process improvement for clinical and commercial production, as well as preparation of IND/BLA registration documents through close collaboration with internal teams and external partners.

2. Take end-to-end ownership of the process development, optimization and industrialization of antibody therapeutics including mAbs and bispecific antibodies. Oversee core activities such as cell line development, upstream cell culture and downstream purification. Lead process design, parameter optimization, process validation and full-scope technical support from lab-scale trials, pilot scale-up to commercial manufacturing,to ensure process robustness, regulatory compliance, cost-effectiveness and scalability.

3. Lead the team to tackle technical challenges, streamline workflow, and establish standardized end-to-end process development systems, technical specifications and SOPs for antibody products.

4. Develop reasonable timelines according to project requirements, lead the team to deliver tasks on schedule, and ensure projects meet all predefined management goals.

5. Provide strong team leadership. Be responsible for team building, talent development and performance management to improve the team’s overall technical expertise. Promote knowledge inheritance, technological innovation and industrial translation of R&D outcomes.

Job Requirements

1. Master or PhD degree in Life Sciences. Minimum 10 years of working experience in biopharmaceuticals including over 5 years in management roles. Proven experience as the primary process development lead in an innovator biotech/pharma company. Job level can be adjusted based on competence and years of experience.

2. In-depth and comprehensive knowledge of process development, covering operational requirements across the entire product lifecycle and relevant regulatory guidelines, with hands-on experience in IND/BLA filings.

3. Served as the lead or key member for at least two antibody programs covering Phase III clinical supply or commercial supply, responsible for full process development, pilot production and technology transfer to      commercial scale. Capable of coordinating upstream and downstream process development in synergy.

4. Accurately define project deliverables, risks and resource requirements. Proficient in project management tools and methodologies to formulate and implement project plans.

5. Strong coordination skills to align cross-functional teams including CMC, R&D, non-clinical and clinical departments, as well as external commercial partners.

6. Outstanding team and personnel management capabilities.