Technical Reviewer - Analytical Development
No salary listed
Mid, Senior
Bachelor's, Master's
Nashville, TN, USA
In Person
Biology & BiotechRegulatory & Quality (Life Sciences)
About the job
Requirements
- A Master's degree with at least 2 years of pharmaceutical experience or a Bachelor's degree with 3–5 years of pharmaceutical experience.
- At least 3 years of experience reviewing current Good Manufacturing Practice 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 including high-performance liquid chromatography and ultra-performance liquid chromatography, liquid chromatography–mass spectrometry, gas chromatography–mass spectrometry, inductively coupled plasma–mass spectrometry, wet chemistry, particle size analysis, capillary electrophoresis, and other pharmaceutical characterization techniques.
- Familiarity with International Council for Harmonisation, Food and Drug Administration, European Medicines Agency, and other global regulatory requirements applicable to analytical development.
- Strong scientific writing, data interpretation, problem-solving, and project management capabilities.
- Ability to clearly convey complex technical information to diverse audiences through written and verbal communication.
- Proficiency in Microsoft Office applications.
- Ability to collaborate effectively within cross-functional, matrixed organizations and establish strong relationships with internal stakeholders and external partners.
- Ability to manage multiple priorities and deadlines in a fast-paced biotech environment.
- Ability to work flexible shifts or weekends to meet timelines.
- Ability to sit for prolonged periods at a desk and work on a computer.
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 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, out-of-specification, out-of-trend, 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.
About the company
August Bioservices is a US-based CDMO offering end-to-end drug development and manufacturing from pre-clinical to commercial. It combines large-CDMO scale with a customer-focused hybrid model to serve startups and big pharma. It provides full development programs including research, development, testing, lab services, and sterile fill/finish under one integrated process, ensuring cGMP and FDA-quality standards. Its goal is to help clients bring safe, effective drugs to market efficiently through a seamless, integrated pathway.
Company Size
51-200
Company Stage
Series B
Total Funding
$88.6M
Headquarters
Nashville, Tennessee
Founded
2017
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Simplify's Take
What believers are saying
- Vial filling qualified in July 2026, unlocking throughput from the $60 million expansion.
- Series B funding in 2025 financed an additional high-speed vial suite and automation.
- August Bioservices' 2026 event calendar signals active business development across BIO, CPHI, and Contract Pharma.
What critics are saying
- Sterile injectable capacity takes roughly 30 months to qualify, delaying revenue from expansion.
- A single FDA contamination finding can halt lines, erase customer trust, and trigger recalls.
- Specialization in sterile injectables concentrates exposure if outsourcing demand shifts or major clients leave.
What makes August Bioservices unique
- Nashville campus offers sterile injectables, development, and manufacturing on one contiguous site.
- August Bio runs fully isolated vial, syringe, and IV bag lines with in-house analytics.
- The 2026 site integrates automated inspection, labeling, packaging, and serialization for faster releases.
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Benefits
- Health Insurance
- Dental Insurance
- Vision Insurance
- Life Insurance
- Disability Insurance
- Health Savings Account/Flexible Spending Account
- Unlimited Paid Time Off
- Flexible Work Hours
- Remote Work Options
- Paid Vacation
- Paid Sick Leave
- Paid Holidays