IrvineRecruiter Since 2001
the smart solution for Irvine jobs

Senior Director of Drug Product Development

Company: Spectrum Pharmaceuticals, Inc.
Location: Irvine
Posted on: June 7, 2021

Job Description:

Summary:

We are seeking a highly motivated professional to perform strategic planning and execution of drug product development and manufacture for its clinical development programs (phase 1, 2, 3), and planned commercial launch. The individual will provide proven leadership on all aspects of formulation development and manufacture for development programs. The individual will have a proven track record of effectively managing a global network of highly qualified Contract-Research Organizations (CROs) and Contract Development and Manufacturing Organizations (CDMOs).

Responsibilities:

  • Design, direct and oversee small molecule formulation development, and manufacturing, with emphasis on the manufacture of registration and validation batches for later-stage assets.
  • Develop strategic project and resource plans for company drug development programs, and provide high-level guidance to senior management on drug product requirements.
  • Effectively lead and mentor team members in all matters related to drug product development that complies with global regulatory requirements.
  • Guide research and design of experiments, manage priorities, risks to meet corporate goals.
  • Author appropriate CMC sections to support global regulatory submissions.
  • Develop relationships and actively manage external parties (CROs, CDMOs, Raw material suppliers, consultants, etc.)
  • Budget, manage financials and forecast all drug product-related expenses.
  • Provide presentations and reports progress on multi-disciplinary development teams, including senior management.

Required Skills, Education and Experience:

  • Ph.D. in pharmaceutical sciences, chemical engineering, organic chemistry, or related discipline with at least 15 years of related industrial experience.
  • Extensive formulation and process development expertise across a broad range of dosage forms.
  • Prior experience managing third parties and external service providers (domestic and international), with emphasis of late-phase late phase/commercial contract manufacturing organizations (CROs).
  • Manufacturing experience and a good understanding of cGMP requirements.
  • Understanding of drug substance, solid form science, and analytical chemistry as related to drug product development.
  • Excellent interpersonal skills, including negotiation skills that ensure corporate outcomes, are met.
  • Strong oral/written communication and presentation skills.
  • Skilled in the preparation and review regulatory filings (including INDs, IMPDs, NDAs, briefing packages or other regulatory dossiers).
  • Excellent risk management, problem-solving and crisis management skills.
  • Ability to work in cross-functional teams as related to drug development.
  • Well versed with the latest technologies, trends and practices in formulation development, manufacturing, and the outsourcing industry.

Availability:

  • Must be available to work in the evenings and weekends, as required.

Position Location and/or Territory and Travel:

  • Position is in the United States (Irvine, CA or Cambridge, MA).
  • Position may require minimal travel, as needed.

Spectrum Pharmaceuticals is an equal opportunity employer, we evaluate qualified applicants without regard to race, color, religion, sex, national origin, disability, veteran status, and other protected characteristics.

Keywords: Spectrum Pharmaceuticals, Inc., Irvine , Senior Director of Drug Product Development, Other , Irvine, California

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Log In or Create An Account

Get the latest California jobs by following @recnetCA on Twitter!

Irvine RSS job feeds