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Km80.5

Senior Scientist/ Associate Director

Principia Biopharma

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Location: South San Francisco, CA Posted Date: 4/22/2013 Position Type: Full time Job Code: Formulation Required Education: Doctorate/PhD Areas of Expertise Desired: Formulation

Description

This position requires hands-on responsibility for pre-formulation and early formulation development of research compounds in support of PK, PK/PD, in vivo and non-GLP tox studies.
Extensive experience with sample prep and HPLC analysis of formulations is required.
Build internal formulation and analytics capabilities in support of on-going projects.
Provide innovative solutions to challenging drug formulations.
Evaluate and select CMOs for preformulation, formulation and analytical development.
Responsible for lead optimization, form selection/characterization, pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes, and CMO management.
Review manufacturing batch records, product development report and other development-related documents.
The incumbent is expected to commit at least 50% of their time to lab work and 50% to management of CMOs.
Perform any other activities related to CMC.
Work as part of a multi-disciplinary team to ensure development of products in a timely and cost effective manner.
Prepare global regulatory CMC documents (INDs, IMPDs etc).
An ideal candidate will foster a culture of high performance, empowerment, learning, and diversity. Attention to detail and commitment to high quality and on-time deliverables is required.
Experience in small and mid-size companies is highly desired.

Requirements

Ph.D. or M.Sc. in pharmaceutics, pharmaceutical sciences, physical or organic chemistry, or a related discipline with at least 5 years industrial experience post Ph.D. degree or 7 years of industrial experience post M.Sc. degree in formulation and analytics.
In-depth knowledge of pharmaceutical formulation principles and analytical test methodologies.
Experience in managing multiple projects both in-house and at CMOs.
Experience with oral solid dosage forms, scale-up and manufacture of clinical supplies.
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