Analytical Development Reviewer — cGMP Data & Method Expert

August Bioservices, LLC; Nashville (TN); On-site; USD 110,000 - 140,000; Full time

Job summary

August Bioservices, a Nashville-based CDMO, seeks an Analytical Documentation Specialist to lead and review reports, methods, and validation activities across development and commercial programs. You will collaborate with scientists, manage lifecycle activities, and ensure compliance with ICH/FDA/EMA guidelines while driving data integrity and timely delivery.

Ideal candidates have a Master’s with 2+ years in pharma or a Bachelor’s with 3–5 years, strong writing, and proficiency in HPLC/LC-MS,

Qualifications

• 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.

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.

Job description

August Bioservices, a Nashville-based CDMO, seeks an Analytical Documentation Specialist to lead and review reports, methods, and validation activities across development and commercial programs. You will collaborate with scientists, manage lifecycle activities, and ensure compliance with ICH/FDA/EMA guidelines while driving data integrity and timely delivery.

Ideal candidates have a Master’s with 2+ years in pharma or a Bachelor’s with 3–5 years, strong writing, and proficiency in HPLC/LC-MS,