Director, Product Development Zogenix, Inc.
The Director of Product Development will be responsible for planning, implementing and managing product development, including delivery system characterization, activities for new drug product development at Zogenix through contract development laboratories, internal studies and at development partners. This person will also be responsible for writing non-manufacturing CMC sections of regulatory submissions.
Major Areas of Responsibility
In collaboration with Zogenix? Senior Development staff, create development strategy to enable rapid drug product candidate regulatory approval.
Participate on drug product development teams by providing direction, oversight and management for outsourced formulation, delivery system and analytical development activities; including Relday? and parenteral combination drug-device products.
Work with Regulatory Affairs to write non-manufacturing CMC sections of all regulatory submissions.
MINIMUM JOB QUALIFICATIONS
Self-motivated individual with the ability to think and work independently
Minimum of 9 years experience in drug-device combination product development, including some experience in suspension or controlled release parenteral drug product development.
Strong understanding of analytical methods development and validation.
Experience in team management, CRO management, and strong background in cGMP?s
PhD in Pharmaceutics or a related discipline, or equivalent combination of education (MS, BS) and parenteral combination drug product development experience.
Excellent communication skills; able to clearly express themselves both verbally and in writing.
Strong understanding of ISO, ICH, FDA and EMEA guidelines pertaining to combination product development.
PREFERRED JOB QUALIFICATIONS
Experience in all aspects of drug product development, ideally spanning IND to registration
Demonstrated success working effectively outside defined scope of responsibility, when required.
Have a bias for action and display a sense of urgency.
Possess strong skills in leadership, communication, project management and budget management while maintaining high quality and efficiency standards.
SPECIAL WORKING CONDITIONS
Up to 5% travel required
||Emeryville, CA |