Careers

Ph.D. Method Development Scientist

Requirements:

 

  • PhD. in Analytical or Organic Chemistry plus 2 years minimum experience in pharmaceutical method development and validation all under cGMP
  • Experience working successfully in a fast-paced work environment.
  • Understanding of USP/EP/ICH guidelines, GMP and FDA regulatory requirements.
  • Technical expertise in chromatography and spectroscopy, with a depth of practical experience on analytical techniques such as HPLC, GC, FTIR, KF, and TOC.
  • Strong attention to detail and creative problem-solving skills
  • Ability to work in a cross-functional team environment.
  • Ability to mentor others as a role-model and to effectively train analysts on analytical methods and techniques.
  • Efficient and organized work ethic to balance multiple tasks and achieve goals.
  • Excellent written and verbal communication skills in working with colleagues within the analytical department and across other departments. Effective communication demonstrated by genuine collaborative approach and responsiveness to working with process chemists and other colleagues.
  • Must display creativity, scientific excellence, highly motivated work ethic and intellectual curiosity.
  • Qualified candidates must be open to periodically working between our Newburyport and Devens, MA sites.

 

Responsibilities:

 Independently develop robust and effective compendial and non-compendial analytical methods for raw materials, in-process control, final product release and stability testing of API, Intermediate, and other products in full compliance with cGMP.

  • Validate analytical methods to prove methods are suitable for intended use based on ICH and USP/EP requirements to support API lifecycle from early development to clinical stages and registration.
  • Write and execute validation protocols and reports based on scientifically sound acceptance critieria established for clinical phase of API.
  • Perform method transfer of analytical methods (from USP/EP/internal and external sources) to Quality Control department to ensure successful analysis of products during manufacture. Provide effective training for QC analysts on new methods and technology.
  • Work with customer and regulatory affairs to establish appropriate specifications for in-process and final release testing.
  • Coordinate effectively with customer for development, manufacture, and release of product for new drug evaluations (NDEs) by supporting analytical aspects of project to meet project timelines.
  • Develop effective methods for the evaluation of cleaning samples in multi-use (API/non-API) manufacturing equipment. Establish limits of recovery of residues from various surfaces of manufacturing equipment to establish safe cleaning specifications.
  • Closely interact with Process Chemists, Regulatory Affairs, Quality Assurance, and project teams to meet analytical development needs.
  • Write and revise Standard Operating Procedures (SOPs) to improve laboratory practices in accordance with changing regulatory environment.
  • Serve as analytical subject-matter expert to help deliver and interpret analytical results related to manufacturing and development variations, Laboratory Investigations (LIR/OOS), Quality Investigations (QI).
  • Provide analytical expertise involving method re-validations, method re-development, and critical reagent qualification.
  • Conduct product degradation studies and qualify in-house reference standards and reference markers suitable for use in API testing.
  • Contribute to regulatory filings through submission of thorough scientific reports related to executed analytical protocols.
  • Provide leadership in (technical and procedural) training for new colleagues to become effective method development or method validation chemists.
  • Identify gaps in existing analytical technology and data processing methods and devise approaches to improve them.
  • Assess and document impact to products of proposed analytical changes.
  • Work with limited supervision and take ownership of projects to achieve schedule, financial and technical goals. Effectively oversee analysts in a team atmosphere to achieve successful outcomes.
  • Provide technical support for the Production, Quality Control and R&D laboratories, including instrument troubleshooting, routine maintenance and training. Use creative solutions to solve problems while maintaining compliance in a changing regulatory landscape.
  • Independently take initiative to learn new analytical technologies in order to develop new methodologies and transfer knowledge/training to Analytical Services department.
  • Maintain accurate and thorough records.

Other duties may be assigned as required

 

Apply to this job

lauren.martin@pcisynthesis.com