AD/Director Pharmaceutical Development - South San Francisco, CA | Biospace
Get Our FREE Industry eNewsletter

AD/Director Pharmaceutical Development

Theravance Biopharma US, Inc.

Apply
Location:
South San Francisco, CA
Posted Date:
11/29/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Doctorate/PhD
Areas of Expertise Desired:
Associate, Development, Director, Pharmaceutical,

Job Description


Job Scope

The main job activities include working in the CMC team and other cross-functional project teams to support and enable the compound and drug product development, including designing and developing formulations and processes, optimizing and scaling up the manufacturing processes, manufacture of clinical trial materials (CTMs) in support of clinical studies, regulatory submission and commercialization.

Duties and Responsibilities

•   As a technical and project lead, as well as subject matter expert (SME), lead the efforts in designing and conducting formulation development, process development, process optimization, scale-up, process validation, clinical and commercial manufacturing
•   Prepare and review manufacturing batch records, product development report and other development-related documents
•   Work with cross-functional teams (CMC, QA, Regulatory and DMPK) to ensure development of products in a timely and cost effective manner
•   Support and enable regulatory submission
•   Evaluate, select and manage contract manufacturers for drug product development scale up and GMP drug product manufacturing

Requirements


Qualifications

•   PhD. in pharmaceutical science or related scientific discipline with 12 + years drug product development experience or BS/MS degree with extensive industry experience (15 + years)
•   Expertise and extensive working experience with parenteral formulation / drug product development, process scale-up and aseptic manufacturing
•   Experience in drug product IND/NDA/IMPD regulatory filing
•   Extensive knowledge and working experience of cGMP and drug product development regulations
•   Experience in selecting and managing CROs/CMOs for drug product development and manufacturing
•   Demonstration of technical leadership, scientific excellence and creativity
•   Demonstration of strong project and team management skills, ability to work effectively with cross functional teams
•   Strong Interpersonal skills, ability to communicate clearly, concisely, and effectively in both written and oral context