Technical Reviewer, Analytical Development

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

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing servicesto pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

Headquartered in Nashville, TN – one of the fastest-growing and most exciting cities in the United States – August Bioservices is a privately-owned, high-growth, and high-impact Contract Development Manufacturing Organization (CDMO). As a US-based outsourcing partner that provides a wide array of expert drug discovery, drug formulation, and drug manufacturing servicesto pharma and biotech companies of all sizes, we play a vital role in the global pharmaceutical industry. Our work is instrumental in helping to develop molecules today that can become the life-changing therapies of tomorrow. To support our growth plans, August is investing significant capital in a two-phase expansion project – including building a new state-of-the-art facility adjacent to our current facility. For those seeking dynamic opportunities, rewarding career paths and a chance to make a difference in global health, come grow with August!

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.

At August Bioservices, Our Credo is our culture. Everything we do, we do with great care. We believe in the promise of discovery and the power of science to transform lives. We assert that excellence is not a static destination, but a standard, and an every-day measuring stick of our advancement. We aspire to unlock the potential in every person, every process and every molecule – from start to finish. We are committed to doing the right thing the first time and every time, meeting or exceeding all regulatory requirements. We strive to be exceptional, preferred and indispensable partners for our customers; responsible and engaged citizens within our communities; and active, mindful stewards of our environment.

We are August Bioservices. We are pointing the way forward. If this sounds like your kind of working environment, we want you on our team!

August Bioservices is an equal opportunity employer and values diversity. All aspects of employment including the decision to hire, promote, discipline, or discharge, will be based on merit, competence, performance, and business needs. August Bioservices does not discriminate on the basis of any status protected under federal, state, or local law.

We may use artificial intelligence (AI) tools to support parts of the hiring process, such as reviewing applications, analyzing resumes, or assessing responses and identifying potential inconsistencies or verification signals in application materials based on available information. These tools assist our recruitment team but do not replace human judgment. Final hiring decisions are ultimately made by humans. If you would like more information about how your data is processed, please contact us.