大型生物药CMO公司招聘工艺VP, 生产 VP，BD VP……

吴红岩医药荐客 2022-01-04

1) VP/Senior Director of PD/AD/MSAT

Responsibilities:

• Lead and manage the PD/AD/MSAT Department, including Cell Line, UPD (Cell Culture), DPD (Purification), Formulation Development, AD (Biology Analysis Development) and MSAT (Tech Transfer) , to achieve the strategic goals of the company.

• Lead and manage the Cell Line and Process Development group (located in Suzhou, China)

• Support the development of clients various biosimilar, bio-better, and fast-follower products for local (China) and global regulatory filings and commercialization.

• Recruit, train, and develop talents at all levels in the PD/AD/MSAT organization.

• Coordinate with the Manufacturing/QA/QC organization for tech transfer of developed manufacturing process to support late-phase and commercial manufacturing.

• Provide technical guidance and support to the Manufacturing group.

• Lead the PD/AD/MSAT groups to conduct extensive comparability (for process changes) and similarity (for establishing bio similarity) studies according to EMA, FDA and ICH guidelines.

• Establish solid documentation systems within the PD/AD/MSAT organization, to record and document all PD studies to support regulatory filings and inspections, as well as business development and financing projects.• Adopt and/or develop new PD/AD/MSAT technologies for improvement of quality, speed, and/or cost effectiveness.

• Other projects and tasks assigned by the CEO or CSO.

Requirements:

• A Ph.D. degree or (related MS degree with rich PD experience) in biological sciences, biochemistry, or bioengineering with at least 10 years of related technical and managerial experiences in the biotech or biopharma industry.

• Excellent communication skills and be bilingual for both English and Mandarin Chinese (proficient in both written and verbal aspects).

• Extensive experience in the process development for therapeutic antibody and/or recombinant protein products that are produced by a CHO-based bioprocess.

• Be familiar with various FDA and ICH guidelines with regard to the development of biologics for therapeutic indications.

2) BP VP

带领BD团队开发海内外业务

3) Sr Director/VP of GMP Manufacturing

Location: Suzhou, China Report to: President

Responsibilities：

· Lead and support tech transfer and manufacturing activities (Cell Culture, Purification and Fill/Finish) for the designated production projects at MFG facility. Serve as CMC leader or single point of contact (SPOC) in the overall CMC team and when interacting with external clients for manufacturing related discussions

o Lead the MFG and tech transfer activities including gap analysis, manufacturing process discussion, manufacturing document preparation.

o Clearly understand and be responsible to track status of MFG and tech transfer, production progress and technical challenges/achievement of production projects, and make appropriate presentation to clients and management

o Ensure client requirements are clearly communicated to production team and management

o Write technical and production reports per requirement of the projects assigned

o Lead/support for preparation and hosting of regulatory inspection and client/QP audit of MFG for projects assigned

o Participate in the review/translation of production batch records, deviation, change control, CAPA and regulatory observation response of projects assigned

· Host client visit and present overview of MFG facility and capability

· Address regulatory observations/audit findings and CAPA of projects assigned

· Participate in PD/QA/QC/AD/MFG technology communication and MFG manufacturing summary, more specifically continuous improvement of

o Facility, especially USP/DSP/Fill/Finish system, establishment (including documentation and initial setting up - i.e. IOPQ)

o PD/MFG platform technology alignment

o Optimization of production execution processes

o Reduction of deviations/investigations from technology aspect

o Work with various MFG teams (and lead as appropriate) on initiatives including, but not limited to, business process improvements, SOP/MBR template updates, production scheduling optimization etc.

Basic Qualifications:

· Master/Ph.D. degree holder in Biotechnology/Chemical Engineering/Biology with more than 10 years of biopharmaceutical industry or related fields. B.S. degree holders with more than 15 years of biopharmaceutical industry background can also be considered.

· Pharmaceutical/biotechnology industry background, including areas but not limited of process development/CMC program management/coordination, QC, manufactory

· Strong communication and social skills in English and Chinese, be fluent in speaking, writing and reading in both languages.

4) 上游工艺-AD/D

5) 下游工艺-AD/D

6) 制剂工艺-AD/D

7) 灌装制剂生产AD/D

往期文章：