Senior Director of Drug Product Development
Company: Spectrum Pharmaceuticals, Inc.
Posted on: June 7, 2021
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).
- 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
- Guide research and design of experiments, manage priorities,
risks to meet corporate goals.
- Author appropriate CMC sections to support global regulatory
- Develop relationships and actively manage external parties
(CROs, CDMOs, Raw material suppliers, consultants, etc.)
- Budget, manage financials and forecast all drug product-related
- Provide presentations and reports progress on
multi-disciplinary development teams, including senior
Required Skills, Education and Experience:
- Ph.D. in pharmaceutical sciences, chemical engineering, organic
chemistry, or related discipline with at least 15 years of related
- 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
- Manufacturing experience and a good understanding of cGMP
- 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
- Excellent risk management, problem-solving and crisis
- Ability to work in cross-functional teams as related to drug
- Well versed with the latest technologies, trends and practices
in formulation development, manufacturing, and the outsourcing
- Must be available to work in the evenings and weekends, as
Position Location and/or Territory and Travel:
- Position is in the United States (Irvine, CA or Cambridge,
- 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
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