Technical Reviewer, Analytical Development

Key Responsibilities

• Lead the preparation, review, and approval of analytical reports, data summaries, protocols, specifications, analytical methods, and other technical documentation.
• Review analytical data packages supporting release testing and stability studies, including raw chromatographic data and Empower-generated reports.

• Collaborate closely with Scientists and cross-functional teams to ensure analytical documentation and reports are completed accurately and within established timelines.
• Support analytical method development, validation, qualification, transfer, and lifecycle management activities across development and commercial programs.

• Prepare, review, and manage technical documents, including analytical methods, validation protocols and reports, specifications, and analytical trend reports.
• Coordinate analytical reporting activities for drug substance and drug product stability programs, ensuring analytical data are accurately documented, assessed, and communicated.

• Participate in investigations associated with deviations, OOS, OOT, and other laboratory events, ensuring appropriate documentation and compliance with quality and regulatory requirements.
• Lead continuous improvement initiatives designed to enhance analytical reporting processes, data integrity, document quality, and operational efficiency.

Qualifications and Experience

• Master's degree with 2+ years of pharmaceutical experience or a Bachelor's degree with 3-5 years of pharmaceutical experience.
• Must have 3 or more years of reviewing cGMP analytical method documents.

• Experience in analytical development, analytical reporting, or related pharmaceutical development functions.
• Strong understanding of small-molecule analytical development, method validation and transfer, stability testing, specifications, and analytical control strategies.

• Demonstrated experience preparing, reviewing, and approving technical documentation, including analytical methods, protocols, and reports.
• Working knowledge of analytical techniques such as HPLC/UPLC, LC-MS, GC-MS, ICP-MS, wet chemistry, particle size analysis, capillary electrophoresis, and other pharmaceutical characterization techniques.

• Familiarity with ICH, FDA, EMA, and other global regulatory requirements applicable to analytical development.
• Strong scientific writing, data interpretation, problem-solving, and project management capabilities.

• Excellent written and verbal communication skills, with the ability to clearly convey complex technical information to diverse audiences.
• Proficiency in Microsoft Office applications

• Proven ability to collaborate effectively within cross-functional, matrixed organizations and establish strong relationships with internal stakeholders and external partners.
• Highly organized and capable of managing multiple priorities and deadlines in a fast-paced biotech environment.

• Able to work in flexible shifts or weekends to meet timelines.

Physical Requirements

• Prolonged periods sitting at a desk and working on a computer.