Director, Formulation Development - South San Francisco, CA | Biospace
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Director, Formulation Development

Principia Biopharma

Location:
South San Francisco, CA
Posted Date:
6/12/2017
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
CMC, Formulation,

Job Description

Principia Biopharma is a biopharmaceutical company engaged in discovery and development of novel small molecule therapeutics in the areas of oncology and autoimmune diseases. As such, Principia Biopharma is comprised of a team of exceptionally talented scientists and business leaders. Our employees experience transparent communication, and the sharing of ideas in an environment of mutual respect. We’re seeking confident individuals who thrive in a culture of diversity, empowerment and accountability. The individual we seek will share these values and is a driven, strategic and collaborative leader wiling to contribute to overall CMC strategy and in particular drive the drug product strategy in support of discovery and developmental programs at Principia. The ideal candidate will foster a culture of high performance, empowerment, learning, diversity and has a desire to be part of the department’s leadership and the willingness to grow in their responsibilities.

Job Description:  In this role you will define the strategy, direct and lead the formulation development for all Principia’s small molecule programs. You will be responsible for managing lead optimization, form selection/characterization, pre-formulation, formulation development, delivery of clinical supplies, development of efficient and scalable manufacturing processes and clinical supply chain management. This position oversees all activities related to both the internal and external formulation development including evaluation, selection and management of CMOs, budget and contract negotiation. You will be responsible for reviewing manufacturing batch records, author and review drug product sections in the CMC sections of regulatory submissions, including supplements to INDs, IMPDs etc. and other development-related documents.

Requirements

Qualifications:  You will have extensive knowledge of current innovative formulation technologies to enable formulation of Principia’s small molecule covalent inhibitors. You will effectively communicate with internal and external project and functional teams, present alternate paths forward, identify and evaluate gaps, provide recommendations and establish new internal and external collaborations to bridge the gaps. You will identify risks to the programs and design scenarios to mitigate the risks. Attention to detail and commitment to excellent quality and on-time deliverables is required.  Experience and knowledge in the interplay between absorption processes, PK/PD relationship with formulation modality is required. The successful candidate should demonstrate recognized scientific leadership as documented by publications, references and external presentations.

Experience and Skills: Ph.D. in pharmaceutics, pharmaceutical sciences, physical or organic chemistry with 15+ years of industrial experience post Ph.D. degree. In-depth knowledge of pharmaceutical formulation principles and analytical test methodologies as well as quality and regulatory guidelines is required. Experience with small molecule oral solid dosage form, scale-up and manufacture of clinical supplies is a must.  Proven track record in developing novel formulations for NCE for both early and late phase clinical trials, managing multiple projects both in-house and at CMOs is desired. Strong project management skills, effective communicator with strong leadership and cross department collaboration skills are necessary. Experience in small and mid-size companies is highly desired. 5 to10 years of prior supervisory experience managing direct reports is preferred.