CASI Pharmeceuticals

Career Opportunities

Project Manager

Job Summary:

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.

Responsibilities:

  • 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.

Minimum/Preferred Requirements:

  • 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:

careers@casipharmaceuticals.com

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.

RESPONSIBILITIES:

  • 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:
careers@casipharmaceuticals.com
CASI Pharmaceuticals, Inc.
9620 Medical Center Drive
Suite 300
Rockville, MD 20850
No phone calls please.

About Us

CASI is a U.S. NASDAQ-listed pharmaceutical company with a platform to develop and accelerate the launch of pharmaceutical products and innovative therapeutics in China, U.S., and throughout the world. We have offices in Rockville, Maryland, and a wholly owned subsidiary in Beijing, China through which substantially all of our operations are conducted.

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