Principal Scientist Tech Services

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 (API’s) 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 (M , 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

• 15+ years 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

Specific Skills

• 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

Physical Requirements

• Business travel less than 5% anticipated
• Will be required to wear a variety of PPE (e.g. PAPR, loose and/or tight fitting respirators, etc.).