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Product Development Project Lead

Capsugel


Location:
Bend, Oregon 97701
Date:
11/13/2017
2017-11-132017-12-13
Job Type:
Employee
Job Status:
Full Time
Shift:
1st Shift, Holidays
Capsugel
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Job Details

Capsugel - now a Lonza company - has an excellent opportunity for a Product Development Project Lead in their Bend, OR location. (formerly Bend Research). The Product Development Project Lead will be accountable for the formulation and process design, development, and manufacturing support for spray-dried products. As the Product Development Project Lead, you will apply your knowledge of chemistry, material science, and engineering to solve drug delivery, formulation, and manufacturing challenges to progress client programs across the spectrum of early stage through commercial development.

 

You'll work closely with the client and internal multi-disciplinary technical teams to define strategy for formulation, process, and product development. Additionally, you'll be responsible in overseeing multiple cross functional product development teams for specific client programs to execute work plans against specific hypothesis and problem statements.

 

Duties include but are not limited to the following: 

  • Work with client and internal subject matter experts to define problem statements and outline technical program strategy

  • Lead the project team to meet project milestones and technical strategy pivots

  • Resolve cross-functional technical issues at project level

  • Anticipate and communicate program changes (strategy/risks/issues) to client

  • Review, interpret, and react to data to make tactical and strategic decisions in order to maintain or change product development plans

  • Define project needs and request staffing and support

  • Accountable for developing and maintaining a detailed project plan to ensure that the right work gets completed to client expectations within deadlines and budgets

  • Manage scope and project plan changes

Requirements

  • Requires a university degree in Chemistry, Chemical or Mechanical Engineering, or other related science/engineering field and 6+ years of experience in drug development or related field

  • MS or PhD in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or other related science/engineering field preferred

  • Experience in bringing a product to market is strongly preferred

  • Requires in-depth knowledge and experience of drug delivery formulation science, pharmaceutical development, manufacturing processes and equipment, and regulation of pharmaceutical products

  • Experience leading multi-disciplinary teams of scientists and engineers preferred

  • Experience strategizing and planning product development, process validation, and ongoing process verification approaches

  • Experience supporting and preparing technical sections of regulatory submissions and interacting with regulatory authorities preferred

  • Industry recognized mastery of pharmaceutical development expertise a plus

  • Familiarity with formulation and process techniques for spray-dried products

  • CMC and regulatory experience with advancing spray-dried products through later stage clinical trials and formal stability studies encouraged

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