Principal Scientist

Scope of Job

• Perform technology transfer, process development, commercial support, and related activities required to concurrently support up to 10-plus new and/or existing commercial drug products at various stages of the product lifecycle.
• No P&L or budget responsibilities.

Key Accountabilities

• Technology Transfer, Process Development, and/or Commercial Support
  • Design and conduct studies for solid-dosage products (qualification of new equipment and new materials, process development/improvement/scale-up, and technology transfer) in compliance with established SOPs, FDA/ICH guidelines, DEA regulations and safety requirements.
  • Performs scientific literature searches and evaluations as required.
  • Provides analysis, evaluation and initial interpretation of varied data including technical assessments of products and manufacturing processes.
  • Performs root cause analysis for product/process related investigations. Uses judgment, creativity, and sound technical knowledge to obtain and recommend solutions.
  • Provide technical evaluation and/or batch execution for alternate source projects for Active Pharmaceutical Ingredients (APIs) and excipients.
  • Effectively leads technicians and technical associates in conducting batch manufacturing and in-process sampling/testing.
  • Provides off hour on-call support to manufacturing.
• Documentation
  • Author/Review GMP documents (MBRs, PBRs, Validation protocols/reports, SOPs) and generates change controls.
  • Author/Review development documents (MBR, Protocols, Control Strategy Reports, and Investigation/Assessment Reports).
  • Write eCTD sections and provide written justifications and answers to complete response letters and information requests from agencies.
  • Ensure all documents are maintained in a complete and orderly manner.
  • Maintain integrity of records, documents, and data at all times.
  • Follow company policies as outlined in the employee handbook.
  • Author technical assessments for required standalone data analysis and present to upper management.
  • Author statistical rational with proper tools applied.
  • Review eCTD sections for accuracy and data integrity.
  • Approve documentation in managers absence.
  • Attend meetings and speak on behalf of manager in their absence.
• Other
  • Provide Validation critical process parameters.
  • Provide Manufacturing, Validation, Compliance and Regulatory Affairs groups with technical input.
  • Collaborate with cross-functional groups across the network to achieve project goals and meet the timelines.
  • Prepares and presents data and recommendations at internal and cross-site meetings.
  • Lead effective cross-functional meetings.
  • Takes personal responsibility for defining, communicating, and implementing decisions in support of project objectives.
  • Motivate and improve the performance of others through mentoring.
  • Review the work of lower-level technical staff.
  • Identify and lead department initiatives to build or optimize internal systems.
  • Provide guidance and necessary training for manufacturing personnel for new/optimized processes/products.
  • Provide timely effective resolution to manufacturing problems of a technical nature.
  • Mentor Jr. Scientists and act/fill in for lead in absence.
  • Other duties as assigned.

Experience Required

• 15+ years of pharmaceutical manufacturing experience in solid-dosage formulation/process development, manufacturing support, scale-up, and technology transfer.
• Bachelor's or advanced degree in Science, Engineering, or Pharmaceutics.

Skills Required

• Possesses project management and facilitation skills and technical competence.
• Competent in English (both written and verbal).
• Excellent technical writing skills with attention to detail and verbal/written communication skills.
• Able to generate high quality technical documentation (Protocols, Reports, MBRs, etc.).
• Proficiency with MS Office.
• Knowledge of data management systems (Master Control, SAP, etc.) commensurate with job expectations are preferred.
• Strong understanding of pharmaceutical solid dose manufacturing concepts.
• Knowledge of pharmaceutical GMPs and regulatory requirements (FDA, DEA, OSHA).
• Possesses applied knowledge of root cause analysis and troubleshooting techniques.
• Able to apply statistical analyses and experimental design techniques.
• Demonstrate adherence to company policies/procedures, compliance/regulatory mandates and quality requirements.
• Team Player with great communication skills.
• Able to lead effective cross-functional meetings when deemed necessary.
• Ability to cross boundaries and sites.

Education Required

• Master's Degree or PhD.