Principal Scientist
Responsible for formulation development and/or review of all associated protocols and technical reports for biosimilar and innovative biologic programs. Evaluate new formulation technology. Represent DPDO on matrix team to progress the pipeline including interfacing with regulatory, nonclinical, and clinical organization to develop appropriate regulatory submissions and respond to agency questions and develop appropriate in-use studies. Collaborate with partner functional groups for the progression of Combination Drug Product in devices (i.e. PFS, NSD, and AI), providing knowledge of the characteristics of the drug product and expertise to any collaborative study design for products delivered via devices. Contribute to resource planning, objective setting and any other business related processes as appropriate. Provide leadership in cross department initiatives.
20 years of experience in biologics that includes formulation and analytical characterization of mAbs
Understanding with hands on experience of analytical techniques as it relates to formulation development
Experience working in a matrix team to progress biologic products.
Experience writing guidance documents for technical processes as it related to biological drug product
Ability to develop plans and deliver results in a dynamic changing environment.
Process development
Time Management Skills
Analytical skills and aptitude
Problem troubleshooting
Authoring and reviewing regulatory submissions
particulate analysis (MFI and HIAC)
Motivated, self-directed and driven
Problem-Solving
Strong organizational skills
Flexibility/Adaptability
Attention to detail and accuracy
Verbal and Written Communication
Multi tasker
According to JobzMall, the average salary range for a Principal Scientist in 145 N Brandywine St, West Chester, PA 19380, USA is $133,000 to $195,000 per year. The salary range depends on a number of factors, including experience, the size of the organization, the industry, and the geographical location.
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Teva Pharmaceutical Industries Ltd., also known as Teva Pharmaceuticals, is an American Israeli pharmaceutical company with dual headquarters in Petah Tikva, Israel and Parsippany, New Jersey, U.S. Teva Pharmaceutical Industries Ltd. engages in the provision of pharmaceutical services. It operates through the following business divisions: Generic, Specialty Medicine, and Over-the-Counter (OTC).
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