ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine
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1 ASCENDIA PHARMACEUTICALS Aspiring for Better Medicine Ascendia Pharmaceuticals, founded in 2012, is a privately-owned, speciality pharmaceutical company dedicated to developing enhanced formulations of existing drug products, and enabling formulations for pre-clinical and clinical stage drug candidates. We specialize in creating formulation solutions for poorlywater soluble molecules and other challenging pharmaceutical development projects. Using our suite of nano-particle technologies, we can assess the feasibility of a broad array of formulation options in order to improve a drug s bioavailability. We execute rapid, comprehensive, and cost-effective programs for our clients. Our technologies include nano-emulsions, amorphous solid dispersions, and production of nano-crystals. Ascendia provides development and testing services - from discovery-stage molecules to life-cycle-management projects - creating formulation solutions with enhanced biopharmaceutical properties suitable for clinical scale-up. Ascendia formulates products for injectable, transdermal, opthalmic delivery, and both immediate-release and controlled-release products for oral administration. Ascendia provides these services to emerging, discovery-based, specialty and generic pharmaceutical and biotechnology companies. Ascendia offers drug development services that encompass preclinical development, pre-formulation development, clinical formulation development, analytical/bio-analytical development, and modeling & simulation of small and biological molecules. Ascendia has a proprietary pipeline of pharmaceutical product candidates, led by ASC-002, a novel, injectable form of the anti-thrombotic drug Clopidogrel and ASD-004, a novel clear eye drop nano-emulsion of cyclosporine for dry eyes. Ascendia Pharma is headquartered in North Brunswick, NJ, with a state-of-theart pharmaceutical research located at the Commercialization Center of Innovative Technology (CCIT), and is also building a 9,000-square foot formulation research and development facility in Xiamen, China. For more information visit us at or contact: Jim Huang, CEO/CSO, j.huang@ascendiapharma.com
2 Scientist/Senior Scientist of Analytical R&D Description About Ascendia Pharmaceuticals: Ascendia Pharma is a dynamic, fast growing specialty pharmaceuticals R&D company located in North Brunswick, NJ. The company s primary focuses are research & development of innovative specialty pharmaceuticals (e.g. enhanced formulation of existing medicine and new chemical entity (NCE), niche hospital drugs, injectable pharmaceuticals) and pharmaceutical R&D development service, leveraging its drug delivery technologies including amorphous solid dispersion, nano-emulsion, nanoparticles, injectable, and controlled release. The mission of our company is to provide customized formulation solutions to salvage difficult compounds and to create advanced medicines to help patients prevail over their disease and enhance quality of life. About the Position: The qualified candidate will take an active role in supporting drug development by applying a variety of analytical methodologies to support physical and chemical characterization of drug substances (including raw materials and intermediates) and drug products. Working knowledge of analytical (e.g., HPLC-UV, HPLC-MS, GC-MS, spectroscopy) and physical chemical techniques (e.g., particle size, dissolution) used for the characterization of pharmaceutical substances and products is desired. Principal Responsibilities: The individual will be responsible for supervising and performing laboratory work in support of analytical testing of pharmaceutical projects and should have experience with the following analytical methodologies: chromatography, dissolution, KF, particle size, or mass spectrometry. Job responsibilities may include analytical method development and validation; stability and release testing; testing to support pharmaceutical development efforts; direct interaction with project team members, including presentation of data; critical review of data; preparation of technical reports; and evaluation of new instrumentation or analytical techniques. The candidate must be able to interact effectively with peers and leaders as part of a multi-disciplinary team and work in a fast-paced environment. Attention to detail, strong organizational skills, the ability to multitask, and effective interpersonal and communication skills are required. Qualifications
3 The position requires a B.S., M.S. or Ph.D. in Pharmaceutical Chemistry, Analytical Chemistry, Chemistry, or Pharmaceutical Sciences with relevant working experience in pharmaceutical industry. A candidate with a Master degree in a relevant field with extensive industry experience will also be considered. Working knowledge in analytical method development and validation under cgmp environment. Experience in problem-solving skills and instrument trouble-shooting. Experience with a wide-variety of software and information systems (e.g. ChemStation, Empower, and LIMS). Good oral and written communication skills and the ability to write and review technical reports and scientific papers are required, and have the ability to use scientific judgment in data evaluation. Working knowledge of pharmaceutical product development, CMC regulatory requirements, project and line management; and capability to collaborate with colleagues. Flexibility to domestic and international travel and fluency in Mandarin and English are desired. EEO/AA M/F/V/D To apply, please submit your CV or resume to HR@ascendiapharma.com.
4 Scientist/Senior Scientist in Formulation Development Description About Ascendia Pharmaceuticals: Ascendia Pharma is a dynamic, fast growing specialty pharmaceuticals R&D company located in North Brunswick, NJ. The company s primary focuses are research & development of innovative specialty pharmaceuticals (e.g. enhanced formulation of existing medicine and new chemical entity (NCE), niche hospital drugs, injectable pharmaceuticals) and pharmaceutical R&D development service, leveraging its drug delivery technologies including amorphous solid dispersion, nano-emulsion, nanoparticles, injectable, and controlled release. The mission of our company is to provide customized formulation solutions to salvage difficult compounds and to create advanced medicines to help patients prevail over their disease and enhance quality of life. About the Position: Ascendia Pharma is looking for a formulation leader for its Pharmaceutical R&D. This position will manage activities related to formulation development under development settings. The successful candidate will be actively involved in developing formulation and manufacturing process and transferring these methods and processes to drug product manufacturers. The candidate will work closely with external product manufacturers to manufacture the formulations throughout all phases of drug development. The candidate will build a group of highly qualified scientists and will be responsible for supervising and mentoring their career development. The ability to work effectively in a collaborative, interdepartmental team environment is essential to this role with the expectation that this scientist will interact with all disciplines of drug development, including discovery, pre-clinical, clinical, pre-formulation, analytical R&D, and regulatory. A thorough understanding of pharmaceutical development process from discovery to commercialization is highly desirable. Principal Responsibilities: Design formulations and process for complex and challenging compounds. Provide strategic direction and guidance to discovery and development programs Actively involved in project management and product development strategies. Handle all technical, legal, and regulatory aspects of development projects. Evaluate, select and manage appropriate CMOs and cgmp manufacturer of drug product for development projects.
5 Participate in discovery and clinical development project team to inform and update the team on the status of all active projects Build the formulation development infrastructure and recruit, manage and provide mentoring to highly qualified scientists and associate scientists. Write and review CMC reports and documentation for regulatory filings. Keep current with regulatory guidelines, technical innovations, and new developments within pharmaceutical industry. Qualifications The position requires a Ph.D. degree in Pharmaceutics, Physical Pharmacy, Chemical Engineering, or Pharmaceutical sciences with relevant pharmaceutical industrial experience. A candidate with a Master degree in a relevant field and extensive industrial experience will be also considered. Demonstrates expertise in solid oral or parenteral dosage form development, process optimization and scale-up. Successful development experience in Innovative approaches to solving formulations challenges and formulation technologies to improve solubility and bioavailability of poorly water soluble drug is preferred. In-depth understanding of preformulation, formulation, biopharmaceutics principles required to get a drug from discovery through clinical development is desirable. Strong scientific expertise, demonstrated by published scientific articles in peer-reviewed journals, society participation, regulatory filings and patents. Proficient in using computer to write and review technical reports and scientific judgment in data evaluation. Flexibility to short/long term international assignment and fluency in Mandarin are desired. Experience in managing scientific personnel and multiple projects, and external CMOs. Excellent communication skills, problem solving, critical thinking, and organization skills. Ability to work in a fast-paced organization with diverse project teams and personnel. Working knowledge of cgmps, Standard Operating Procedures, FDA/EMA/JP/SFDA regulations, and safety will be a plus. Knowledge in pharmaceutical product development, CMC regulatory requirements, project and line management; and capability to collaborate with colleagues. EEO/AA M/F/V/D To apply, please submit your CV or resume to HR@ascendiapharma.com.
6 Office/Business Administrator Description About Ascendia Pharmaceuticals: Ascendia Pharma is a dynamic, fast growing specialty pharmaceuticals R&D Company located in North Brunswick, NJ. The company s primary focuses are research & development of innovative specialty pharmaceuticals (e.g. enhanced formulation of existing medicine and new chemical entity (NCE), niche hospital drugs, injectable pharmaceuticals) and pharmaceutical R&D development service, leveraging its drug delivery technologies including amorphous solid dispersion, nano-emulsion, nanoparticles, injectable, and controlled release. The mission of our company is to provide customized formulation solutions to salvage difficult compounds and to create advanced medicines to help patients prevail over their disease and enhance quality of life. About the Position: Office Administrator duties and responsibility includes providing administrative support to ensure efficient operation of the company. You will support managers and employees through a variety of tasks related to organization and communication. The admin job scope includes communicating via phone and , book keeping, documentation, HR function, business support ensuring that all administrative duties are completed accurately and delivered with high quality and in a timely manner. Principal Responsibilities: Answer and direct phone calls Organize and schedule meetings and appointments Maintain contact lists Produce and distribute correspondence memos, letters, faxes and forms Assist in the preparation of regularly scheduled reports Develop and maintain a filing system Order office supplies Book travel arrangements Submit and reconcile expense reports Provide general support to visitors
7 Book keeping HR function Qualifications Proven admin experience in pharma, chemistry, medical office, or relevant fields is desirable Knowledge of office management systems and procedures Excellent time management skills and ability to multi-task and prioritize work Attention to detail and problem solving skills Excellent written and verbal communication skills Strong organizational and planning skills Proficiency in MS Office Degree or associate degree in business, science, accounting or relevant fields EEO/AA M/F/V/D To apply, please submit your CV or resume to
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