CASI Pharmaceuticals is seeking a project manager to manage product registration, clinical supply and technical transfer through commercial launch.
He/she will support license in/out, regulatory document preparation and furtherdossier filing at FDA and/or CFDA.
- Establish and maintain product related data room, central filing system and security distribution log.
- Support DMF document preparation, submission and central filing.
- Support supply and purchase ordering and fulfillment.
- Manage the relationship with partners and alliance mutual objectives achievement.
- Collaborate with internal stakeholders on driving project progress and shoot for solutions.
- Present project milestone, issues and support needs to senior management.
- Track and oversee the activities of project progress, timeline and resource allocation,highlight event alerts to senior management and risk management.
- Alliance management with external partners.
- BS in a scientific field required.
- At least 2 years project management, supply chain management, or regulatory affairs experience in pharmaceutical/biological industry.
- Excellent communication, writing and computer skills.
- Excellent interpersonal and presentation skills.
- Fluent in oral and writing in English and Mandarin
ABOUT CASI PHARMACEUTICALS:
CASI is a biopharmaceutical company focused on the acquisition, development, and commercialization of quality pharmaceuticals and innovative therapeutics addressing cancer and other unmet medical needs for the global market, with a focus on greater China and the U.S. We are a NASDAQ-listed company headquartered in Rockville, Maryland with a wholly owned subsidiary and R&D operations in Beijing, China.
How to Apply:
Please send your resume and cover letter:
VP/Head of Generics Division
CASI Pharmaceuticals, Inc. is seeking a VP/Head of Generics Division which will provide technical, operational
and strategic leadership and expertise in manufacturing, technology transfer operations to ensure the GMP
manufacture and supply of high quality generic products to support late stage product development and
commercialization, and to oversee China and U.S. regulatory filings, manufacturing and compliance. This
individual will possess Pharmaceutical Generic Drug Development Experience, experience working on programs
focusing on the development of generic pharmaceutical products, technical transfer to manufacturing in China
and in U.S. if applicable. This drug development experience would include formulation, chemistry, regulator
knowledge etc. The Company is located in Rockville, Maryland with operations in Rockville and Beijing, China.
- Actively manage Contract Manufacturing Organizations (CMOs) in China (and in U.S. if applicable), network to build a sustainable GMP manufacturing organization to support multi-product portfolio in Generics business unit.
- Act as the primary contact with the CMO to ensure effective collaborations with relevant internal functions.
- Ensure efficient technical transfer of manufacturing processes to CMOs.
- Partner with internal functions to define project and program objectives, deliverables, and annual and long-range operating work plans; identify resources (e.g. FTEs, budget, etc.); and ensure execution and progress towards deliverables and milestones.
- Ensure CMO network supplies high quality products for development and commercialization through batch record review, deviation assessment, batch disposition and supply chain oversight, etc.
- Oversee CMO supply chain including critical raw materials.
- Partner with Quality functions to ensure timely and appropriate batch disposition.
MINIMUM/ PREFERRED REQUIREMENTS:
- Education: BS/MS or PhD in a scientific field required
- Experience: 10+ years broad experience in pharmaceutical industry and a minimum of at least 7 years of experience within Generic Pharmaceutical market
- Experience in Operations, CMC and other related areas with emphasis on project management of commercial product portfolio assets in pharmaceuticals
- In-depth technical and regulatory understanding of GMP chemical manufacturing and supply chain, as well as applicable China regulations and standards in all phases of product development, including late-stage through commercialization
- Late stage/ commercial experience required
- Strong understanding of CFDA and FDA requirements related to Pharmaceuticals and Generics
- Driven self-starter
- Strong written and verbal communication skills; well organized and attention to detail
- Proven leadership experience and people management skills with the desire and ability to work in a fast- paced, start-up environment
- Experience working with and managing third-party contractors and vendors
- Chinese (Mandarin) fluency preferred
ABOUT CASI PHARMACEUTICALS:
CASI is a biopharmaceutical company focused on the acquisition, development, and commercialization of quality
pharmaceuticals and innovative therapeutics addressing cancer and other unmet medical needs for the global
market, with a focus on greater China and the U.S. We are a NASDAQ-listed company, headquartered in
Rockville, Maryland with a wholly owned subsidiary and R&D operations in Beijing, China.
Please send your resume and cover letter:
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive
Rockville, MD 20850
No phone calls please.
MANAGER OF BUSINESS DEVELOPMENT
Search & Evaluation – External Innovation
CASI Pharmaceuticals, Inc. (NASDAQ:CASI) is a biopharmaceutical company dedicated to the acquisition, development and commercialization of innovative therapeutics addressing cancer and other unmet medical needs for the global market with a primary commercial focus on China. We focus on building a pipeline through mutually beneficial business development transactions. Our strategy leverages our resources and expertise in China to develop and commercialize innovative products in China and other markets.
We are a NASDAQ-listed company. Although we are headquartered in Rockville, Maryland with R&D operations in Beijing, we welcome and will consider a remote-based position, particularly in the San Francisco area, Boston or other strategic locations. The position can be director level, depending on the candidate’s experience and skill set.
We are currently seeking a Manager of Business Development, Search & Evaluation for External Innovation, who will work with and report to the VP of Business Development. The Manager will search and evaluate new opportunities that will support executing the business strategy of the Company with the goal of developing prospects with biotech and pharmaceutical companies looking to expand into the Chinese region and report these opportunities to the VP of Business Development. Specifically, we are looking for regional rights with regard to innovative, patented therapeutics currently in late-stage clinical trials that are not currently available or approved in China, or earlier-stage products in innovative areas.
The Manager will identify corporate alliances for drug candidates to be developed in China and work with the VP of Business Development to execute on these opportunities. The candidate would assist the VP of Business Development by attending meetings and industry conferences. It is imperative that the potential candidate becomes familiar with CASI’s products and strategies to facilitate presenting the programs to potential partners.
Successful candidates must have a Bachelor’s degree in business or a scientific discipline; a degree in a life science plus a M.B.A. would be ideal. A minimum of 5 years of transactional business development experience. The ideal candidate must have strong technical/scientific skills as well as experience in the biotech/pharma industry in order to assist the VP, of Business Development in attending partnering meetings, scientific/clinical conferences and search multiple sources for new BD leads. Excellent presentation, oral, and written communications skills are a must. Candidate must be able to prioritize and juggle multiple projects and opportunities at once.
CASI offers an excellent compensation and benefits package and is an equal opportunity employer. Please send resume, cover letter, and any supporting materials to CASI’s human resources, attn.: firstname.lastname@example.org. All candidates must successfully pass a criminal background check.