By Victor Chen, bostonese.com
Cambridge, Mass., Dec. 23, 2014, — The classroom of MIT Sloan School of Management was packed with close to 100 attendees of the 17th SAPA-NE Scientific Symposium in the afternoon of Dec. 6. “The new frontier therapeutics: stem cells and regenerative medicine” was the title of this year’s symposium.
Speakers and SAPA-NE organizers pose for a picture(photo by Victor Chen).
The 17th SAPA-NE Scientific Symposium featured leading investigators from the fields of stem cells and regenerative medicine. “Stem cell and regenerative medicine” was selected as the main theme of the symposium to reflect the latest scientific discovery in stem cell research and cutting-edge application in medicine.
This symposium provided participants a great opportunity for professional learning and networking with the prestigious academic researchers and industrial scientists.
A week later on Dec. 13, SAPA-NE hosted a talent recruitment event for Kulun Pharmaceutical Group across the Main street at Marriott Hotel in Kendall Square. Founded in 1996, Kelun Group has developed into a modern pharmaceutical group, with 87 subsidiaries (branches) throughout China, all this rapid development took place within just 18 years.
Kelun Group’s total sales in 2013 exceeded RMB 35 billion or about $5.6 billion. According to the 2012 Sales Ranking of Chinese Drug Circulation Industry released by the Ministry of Commerce and the Pharmaceutical Statistic Annals of the Ministry of Industry and Information Technology (MIIT), the business and industrial segments of the Kelun Group ranked within the Top 10.
By holding the recruitment event just outside MIT campus, Kelun Group targets high level talents in the Great Boston area who can lead the complex process of drug discovery and development. The following is some opening positions.
US Kelun Pharmaceutical Co., Ltd.
Talent Recruitment (USA)
VP/Director –cGMP Manufacturing/ Quality Assurance
Location, New Jersey/China, USA
Responsibility:
- Assist general manager in operations in USA and direct new cGMP workshop planning and construction or renovate existing workshop in China and ensure these workshops compliance to the FDA drug manufacturing regulations (21 CFR Part 210, 21 CFR Part 211) and guidelines, site SOPs, protocols, and industry standards / CGMPs, as applicable.
- Responsible for directing technical transfer, scale up and FDA onsite inspection activities.
- Responsible for directing quality assurance (GMP QA) activities for sterile generic injectable product development, manufacturing and commercial product launch.
Requirements:
- Bachelor’s degree in pharmaceutical science or related field required.
- Minimum of 10 years’ generic sterile injectable pharmaceutical experience in the FDA international inspection prefer in China, manufacturing, scale up, technical transfer, quality assurance, audit, project management and regulatory compliance.
- Expert knowledge of FDA, ICH cGMP requirements regarding cGMP (new manufacturing workshop and renovate existing workshop, generic sterile injectable product development, technical transfer, and manufacturing and ANDA submission).
- Strong knowledge and understanding of the approach and perspectives of regulatory agencies.
- Must be able to interpret and apply CGMP regulations and guidance independently.
- Excellent writing, communication and presentation skills.
- Demonstrated leadership and project management skills.
If you are interested, please send your resume to: [email protected]/[email protected], or call 86-28-67255175; 217-853-0067 for more detailed information.