Sr. Director, Analytical Development - South San Fransico, CA | Biospace
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Sr. Director, Analytical Development

Portola Pharmaceuticals, Inc.

Location:
South San Fransico, CA
Posted Date:
10/31/2016
Position Type:
Full time
Job Code:
Salary:
Required Education:
Masters Degree
Areas of Expertise Desired:
Analyst, Development, Director,

Job Description

Portola Pharmaceuticals is looking for a Senior Director of Analytical Development.  The successful candidate will lead a small group of analytical development scientists and research associates to support Portola’s protein drug candidates.   A primary responsibility will be to develop, plan, lead and execute analytical development strategies for biological drug candidates from early development through all phases of commercialization.  This includes responsibility for generation and documentation of all analytical data needed to support INDs/BLAs and comparability programs to support a sequence of manufacturing changes for biological drug candidates. This person will be an integral member of the Technical Operations team whose work enables product/process/formulation development, QC testing & characterization of products; as well as provides key information in support of CMC regulatory submissions.   He/she will provide technical leadership to development and troubleshooting during development, manufacture, release and stability testing of protein development candidates, and regulatory submissions.  He/she will also manage department budget to ensure cost effective operation and timely delivery on corporate goals.


Responsibilities:

•   Lead team in development, planning and execution of analytical development strategies and preparation of related reports and regulatory submissions to support clinical testing, regulatory approvals, and comparability programs which support a sequence of manufacturing changes for biological drug candidates

•   Lead development and qualification of analytical methods for in-process, drug substance and drug product release and characterization for biological drug candidates will also lead the development, establishment and justification of related material, drug substance and drug product specifications

•   Manage analytical transfers to CRO(s) for clinical phase GMP testing, and support process technology transfer to cGMP CMOs

•   Ensure technical and analytical development expertise is provided for product and testing investigations  

•   Manage relationships with existing and new CROs/CMOs, including managing timelines and cost for the analytical development in support of manufacturing activities performed at CMOs

•   Prepare, review and deliver technical reports and documents in preparation for regulatory submissions

•   Recruit, train, manage, and motivate direct reports as well as consultants to efficiently and effectively deliver on goals

•   Ensure appropriate application of key guidance, procedures and policies throughout development and commercialization

•   Identify  opportunities for quality enhancement and operational efficiencies and develop effective methodologies to track the progress

•   Work independently and exercise appropriate judgment


Requirements

•   A PhD or MS in the physical or biological sciences, with 10+ years of hands-on and leadership experience in analytical method development and validation, in support of biologic drug development projects

•   Must have experience in leading teams (internal and external/contract labs) in developing and executing analytical development plans and documenting in reports and regulatory submissions for biological drug candidate comparability programs

•   Must be familiar with cGMP practices for analytical laboratories and with EHS/ DEA regulations and ICH and FDA guidance

•   Demonstrated capabilities and proven track record of problem solving during pre-clinical and clinical drug development in a dynamic work environment

•   Must have significant experience in completing the analytical aspects of regulatory submissions

•   Must have the ability to communicate effectively, make presentations and write concise reports for senior management and all levels of employees

•   Highly motivated team player willing to contribute to a growing biotech organization