| Job Description | About Ascendia Pharmaceuticals:
Ascendia Pharma is a dynamic, fast growing specialty pharmaceutical company located in
North Brunswick, NJ. The company’s primary focuses are research & development of
innovative specialty pharmaceuticals (e.g. enhanced formulations of existing medicines, new
chemical entities (NCE), and niche injectable pharmaceuticals) and pharmaceutical R&D
development services. We leverage our proprietary drug delivery technologies including
nano-emulsions, amorphous solid dispersions, and nano-particle formation. The mission of our
company is to create advanced medicines to help patients prevail over their disease and
enhance their quality of life.
About the Position:
Ascendia Pharma is looking for a formulation leader for its Pharmaceutical R&D team. This
position will manage all activities related to formulation development under discovery and
development settings. The successful candidate will be actively involved in developing
formulation and manufacturing processes 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 processes 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.
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 formulation
challenges, and in formulation technologies to improve solubility and bioavailability of poorly
water soluble drugs is preferred.
In-depth understanding of pre-formulation, formulation, and 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 writing and
reviewing technical reports, and excellent scientific judgment in data evaluation.
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.
Flexibility for domestic and international travel, and fluency in English and Mandarin are
desired. |
| | Company | | Ascendia Pharmaceuticals, LLC | Job Code | | State or Province | | New Jersey | | |
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