Job Opportunities

1、Head of Clinical/Medical operation (Director)

Base: Open

Roles & Responsibilities:

●  Be the point person and leader for CONNECT’s clinical operation and be accountable for ensuring the delivery of high quality clinical trial data

●  Participate in establishment of CONNECT’s clinical development strategy; Translate the strategy into executable action plans and establish priorities in line with company goals and priorities

●  Coordinate and participate the IND package preparation,facilitate and support IND submission

●  Establish and lead internal clinical/medical operation team/system; Coordinate Clinical Research sites and Manage Clinical CRO team(s), and other roles as relevant

●  Be responsible for ensuring execution of clinical trials. Proactively identify key issues in clinical trial execution, propose appropriate solutions and organize follow-up resolving implementation, ensuring compliance with ICH/GCP and local authorities guidelines

●  Build effective working relationships with regulatory bodies, as well as KOLs/PIs; and organize communication in a timely manner with CFDA/FDA (e.g. end of phase II meeting and etc.), and handle inspections by external bodies including regulatory authorities

●  Be responsible for clinical program team budget and operating expenses

●  Frequent domestic (and occasionally International) travel required

 

Education/Qualifications:

◇  An undergraduate or above degree in life sciences or health-related field from an accredited institution or its international equivalent preferred

◇  Thorough knowledge of ICH and local regulatory authority regulations is a must and a minimal of 8 years clinical development/operation experiences in China is required, CRA/CRC China experiences is a plus

◇  Excellent organization and coordination and interpersonal communication skills, Direct supervisory experience with a successful track record of mentoring junior staff is preferred

◇  Highly motivated self-starter, enjoy working both independently and collaboratively in a fast-paced team environment. Capable of working under pressure and willing to travel frequently

◇  Adequate experience using computerized information systems including MS Office software is required. Proficient in Chinese and English

 

 

2、Clinical Program Manager (or Supervisor)

Base: Taicang or Beijing/Shanghai/Guangzhou

Roles & Responsibilities:

●  Actively participate in the compilation of relevant IND application packages, supporting the International (e.g. US FDA or Australian TGA) and domestic (CFDA) IND submission;

●  Participate in the establishment and effective operation process optimization to facilitate CONNECTs clinical research programs; work closely with clinical CROs and facilitate the supervision and management of CRCs/CRAs’ work for efficient and qualified delivery of clinical research compliant to GCP;

●  Be the point person and leader for CONNECT’s clinical operation and be accountable for ensuring the delivery of high quality clinical trial data

●  Participate in the inspection of the government (Law) department and related customers, organize, participate in or cooperate with the company

 

Education/Qualifications:

◇  An undergraduate degree or above in life sciences or health-related field from an accredited institution or its international equivalent preferred

◇  Knowledge of ICH and local regulatory authority regulations and a minimal of 4 years clinical development/operation experiences in China is required for Manager level position, CRA/CRC China experiences is a plus

◇  Capable of using MS Office software is required. Willing to travel frequently

◇  Excellent organization and coordination and interpersonal communication skills, and self-motivated; Proficient in Chinese and English

 

 

3、Scientist/Group Leader, Cell Biology/in vitro Pharmacology

Base: Taicang (Suzhou), Jiangsu Province

Roles and Responsibilities:

●  Lead the effort in cell line development and developing in vitro biological assays

●  Responsible for the implementation of a broad range of biochemical and cellular assays that address project needs

●  Responsible for providing robust in vitro screening and drive lead optimization and obtain mechanistic insights for all internal research programs

 

Education/Qualifications

◇  PhD or equivalent in a relevant scientific discipline and at least 3 years of drug discovery experience, robust experimental design and troubleshooting skills, and excellent data analysis/mining/statistics capabilities, In-depth expertise in immunology/inflammation is preferred

◇  Strong hands-on experiences in cellular biology/pharmacology, Experience with automation technologies is preferred

◇  Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

◇  Highly motivated self-starter, proficient in English and Chinese

 

 

4、Senior Scientist/Director, Antibody Engineering

Base: Taicang, Jiangsu

Roles and responsibilities

●  Organize and coordinate the internal and external resources, and participate in the early discovery, humanization and affinity maturation optimization of the new antibody, until the commercialization of cell lines can be built.

●  Lead to build the internal technology platform for antibody scale-up process development and formulation, and drive the scale-up and formulation exploratory studies that address project needs

 

Education/Qualifications:

◇  Ph.D. degree or equivalent in Life sciences or a relevant scientific discipline, familiar with antibody sequence analysis, related antibody display, humanization and affinity transformation technology, have antibody drug research and development experience, especially antibody technology amplification and preparation research experience preferred.

◇  At least 8 years experiences in antibody drug discovery, successful track record in antibody scale up and formulation is definitely preferred

◇  Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

◇  Highly motivated self-starter, proficient in English and Chinese

 

 

5、Scientist, Antibody Pilot Expression and purification

Base: Taicang (Suzhou), Jiangsu province

Roles and Responsibilities:

●  Participate in establishment of the technology platform for antibody pilot production, including cell culture medium screening, shake flask cell culture process optimization, and bioreactor cell culture process optimization, and etc.

●  Organize and participate in the development and optimization of related antibody drugs, provide technology transfer to support the scale-up production process.

●  Undertake the pilot production of related antibody drugs.

 

Education/Qualifications:

◇  M. Sc. Degree or equivalent in life sciences or a relevant scientific discipline

◇  In-depth knowledge of cell culture bio-reactors, hands-on experiences antibody expression and purification

◇  Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

◇  Highly motivated self-starter, proficient in English and Chinese

 

 

6、Manager, Quality Assurance and Laboratory operation

Base: Taicang (Suzhou), Jiangsu Province

Roles & Responsibilities:

●  Lead to organize and coordinate the internal and external resources for establishing Connect’s quality management system

●  Plan the QC/QA work and responsible for the implementation

●  Participate in the plan of laboratory operation, and be responsible for monitoring the implementation

●  articipate in the plan and implement of EHS system as a core member

●  Responsible for budget and cost control of quality management system, laboratory operation and EHS system


Education/Qualifications:

◇  A bachelor degree or equivalent or above in relevant fields such as biology, chemistry and etc.

◇  Knowledge of quality control and assurance system (e.g. GLP, GCP and GMP), minimal of 3 years working experience as a QC/QA staff in biotech industry setting

◇  Excellent communication, and organizational skills are required, direct supervisory experience with a successful track record of mentoring junior staff is preferred

◇  Highly motivated self-starter, proficient in English and Chinese


TEL/FAX: 0512-53577866

E-MAIL: qchang@connectpharm.com

ADD: 10th Floor, XiangTang Development Building #3 ChaoYang Dong Road, Taicang,Jiangsu Province, China ,215400

Copyright: Suzhou Connect Biopharmaceuticals, Ltd.

Technical support: Epower