Company
PrincipalScientist
Neural analysis suggests this role is
optimal for Lead candidates.
“Principal Scientist. Skills: Extractables & Leachables (E&L) expertise, Study design and execution, Regulatory compliance, Analytical chemistry, Mass spectrometry. Provide leadership and direction to the Extractables & Leachables (E&L) team. Manage study execution and associated processes”
What You'll Achieve.
Ensure efficient and compliant program delivery; Generate high-quality data to support regulatory submissions; Align E&L strategies with product development goals and timelines; Support product development and regulatory submissions; Ensure alignment with global regulatory standards; Respond to FDA queries with clear, scientifically sound justifications supported by robust data and technical expertise; Address regulatory deficiency responses related to E&L
Industry & Context.
Solving problems; Identify trends/exceptions/interpretations of results
All employees are responsible for ensuring compliance with company documents, programs, and activities related to the Health, Safety, Environment, Energy, and Quality Management Systems, as per your roles and responsibilities.
What They're Looking For.
Must Have
Bachelor’s degree in Chemistry, Pharmaceutical Sciences Biological Sciences with seven plus years of related experience, Master’s Degree in Pharmaceutical Sciences, Chemistry, Biological Sciences with 5 years of related experience, PhD in Chemistry, Pharmaceutical Sciences, Biological Sciences, Chemicaliomedical Engineering with one to three years of related experience
Nice to Have
Sufficient knowledge and work experience in extractable and leachable, Sufficient knowledge and work experience in Mass spectrometry, Basic understanding and work experience in various mass spectrometry techniques, such as HS-GC/MS, GC-MS, HRLC/MS, and ICP/MS, Prior Extractable and Leachable OR Mass spectrometry OR Trace level impurity analysis work experience in an industry or a CRO environment
What You'll Do.
Provide leadership and direction to the Extractables & Leachables (E&L) team
Manage study execution and associated processes
Oversee the full lifecycle of E&L activities
Conduct thorough technical evaluations
Approve study reports
Perform Extractable and Leachable testing in the lab
Prepare and review regulatory affairs (RA) documentation for Extractables & Leachables (E&L) studies
Evaluate analytical results and identify trends/exceptions/interpretations of results
review and approve E&L analytical testing protocols and reports
Prepare E&L studies and safety assessment summaries for regulatory dossiers
Address regulatory deficiency responses related to E&L
How You'll Work.
Team & Collaboration
Collaborate closely with analytical and formulation teams; Collaborate cross-functionally with analytical, formulation, and development teams; Communicate clearly with the manager, peers, cross-functional teammates, and non-technical audiences; Seek input from other team members
Communication Scope
Excellent written and verbal communication skills; Communicate clearly with the manager, peers, cross-functional teammates, and non-technical audiences; Openly sharing project status and hurdles
Process & Methodology
Prioritizing workstreams, Ensuring efficient and compliant program delivery, Ensuring studies are designed, conducted, and reported in a timely, compliant, and scientifically sound manner, Manage competing priorities
Full Job Description
# # **Job Summary** Provide leadership and direction to the Extractables & Leachables (E&L) team, managing study execution and associated processes to ensure efficient and compliant program delivery. Oversee the full lifecycle of E&L activities, including study design, protocol development, and execution, ensuring high-quality data generation to support regulatory submissions, including FDA applications. Conduct thorough technical evaluations and approve study reports, risk assessments, and documentation to ensure scientific integrity and compliance. Collaborate closely with analytical and formulation teams to align E&L strategies with product development goals and timelines. Serve as the primary owner of E&L activities, with the expectation to grow into a subject matter expert and provide strategic scientific guidance as the program evolves. Salary Range: $80,000-95,000 Final pay determinations will depend on various factors, including, but not limited to experience level, education, knowledge, skills, and abilities. Our benefits and programs are comprehensive and thoughtfully crafted to ensure our colleagues live healthy lives and have support when it matters most. Benefits offered include a 401(k) plan with company contributions, paid vacation, holiday and personal days, employee assistance program, and health benefits to include medical, prescription drug, dental and vision coverage. # # **Responsibilities** # * Lead and mentor the Extractables & Leachables (E&L) team, providing technical direction, prioritizing workstreams, and ensuring effective execution of study activities. * Oversee the end-to-end E&L program, ensuring studies are designed, conducted, and reported in a timely, compliant, and scientifically sound manner to support product development and regulatory submissions. * Collaborate cross-functionally with analytical, formulation, and development teams to align E&L strategies with overall product and regulatory objectives. * Serve as the primary poi
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