Senior Manager, Manufacturing Process Develop

Pernix Therapeutics   •  

La Jolla, CA

Industry: Pharmaceuticals & Biotech


8 - 10 years

Posted 53 days ago

Summary of Job:

The Senior Manager Manufacturing Process Development will oversee process development, scaleup and improvements to commercial processes at contract service providers. The incumbent will be responsible for resolving complex issues where analysis of situations or data requires an in-depth analysis of process data acquired from multiple sources. The individual will be an internal process expert that establish metrics, analyzes data and makes recommendations to the management team. He or she may lead project teams responsible for manufacturing development, material and equipment qualification, and investigations of process variances.

Essential Duties and Responsibilities:

The Senior Manager is responsible for the development and support of manufacturing processes for solid oral dosage products at third party contract service providers. Activities would include but are not limited to:

  • Development of process improvements for API and raw materials, equipment qualification, and drug product process development, qualification and support at contract service providers
  • Provide oversight at manufacturing sites for process changes
  • Author technical reports documenting process improvements
  • Define and maintain a database of manufacturing data that supports the life-cycle of a product from development through late-stage commercialization
  • Reviews and approves validation and production documents, including protocols, development reports and batch documentation
  • Resolves deviations and CAPAs related to manufacturing operations
  • Ensures quality and regulatory compliance include, authors drug product CMC sections for regulatory filing
  • Develops a data collection plan and statistical method analysis to collect relevant manufacturing information for evaluation of process capability and stability
  • Makes recommendations based on the analysis of data to drive effective, well-informed decision making
  • Resolve outstanding quality issues, deviations and CAPAs
  • Lead project teams

Job Requirements:


  • A minimum of a Bachelor of Science degree in Engineering, Pharmacy or a related discipline.
  • Experience:
  • A minimum of 8 years relevant experience in pharmaceutical development or operations including at least 3 years of solid dosage manufacturing. Must have experience in the following areas:
  • Experience in late-stage solids dosage process development, technology transfer and commercial manufacturing technical support.
  • Analysis and interpretation of data
  • Authoring and review of quality and regulatory documents
  • Experience simultaneously managing multiple projects at contract service providers
  • Other Skills and Abilities:
  • Strong written and verbal communication skills. Must have a demonstrated ability to present data summaries and recommendations in a clear concise manner.
  • A quality mindset with good documentation and record keeping skills
  • Ability to travel domestically and internationally (up to 30% of time)