抗体CDMO公司招聘CTO-中/美

Chief Technology Officer-Antibody

Role Description:

这个职位可以中美俩地进行管理工作，在国内最少要工作3-4个月。综合管理技术，生产，运营和商务等团队。团队规模500-1000人

We are looking for Chief Technology Officer to lead the China GMP manufacturing team. You will lead the manufacture effort for both antibody and GCT in the business unit.

Your team will ensure our manufacture processes follow the appropriate scientific, regulatory and quality standards under GMP system. You will provide strategic leadership to establish and maintain manufacturing procedure and ensure GMP compliance.

We are planning to establish PAD production line. The first phrase 4*2000L – PAD, and second line 8*2000L. Also there is over 10,000 square meters manufacturing plant of GCT in the future.

Key Responsibilities:

1. Supports to establish GMP manufacturing facility consisting of design, construction, validation of facility, and GMP operation system.

2. Oversees the preparation and management of complex GMP manufacturing facility development plans, budgets, and long range planning.

3. Oversee daily operations in a multi-product GMP facility, manage and control production schedule;

4. Ensures all manufacturing and process validation activities relating to drug substance and drug product are completed in accordance with quality and regulatory expectations to support relevant global regulatory submissions.

4. Collaborate with QC&QA groups to ensure GMP compliance, contribute to deviation and CAPA system, and support client auditing and agency inspections.

5. Recruit, retain and develop talents, and provide leadership for a high performing team to meet our overall business objectives.

6. Perform other duties as assigned based on business needs.

Qualifications:

1. A master or bachelor degree in biological science, chemistry or a related discipline with at least 7 years of industry experience or a bachelor’s degree with 10 years of industry experience.

2. Technical knowledge and hands-on experience in GMP manufacturing of monoclonal antibodies or other protein therapeutics.

3. Experience in GMP facility design and construction, equipment selection, qualification and validation.

4. Experience in large-scale manufacturing operations with GMP

Requirements.

5. Experience in CMC regulatory affairs for US FDA, cFDA and EMA is a plus.

6. Direct management experience with successful track record of building, coaching and mentoring a high-performing team.

7. Strong interpersonal, verbal, and written communication skills.

8. Bi-lingual, fluent in Chinese and English reading, writing and conversation.

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