Technical Reviewer, Analytical Development

August Bioservices LLC; Nashville, Northern (TN, KY); Presencial; USD 90.000 - 130.000; Jornada completa

Descripción de la vacante

August Bioservices in Nashville, TN is seeking an experienced Analytical Documentation Specialist to lead the preparation, review, and approval of analytical reports, methods, and data. You will collaborate with Scientists and cross-functional teams to ensure timely, compliant documentation across development and commercial programs.

Responsibilities include supporting method development and validation, reviewing data packages for release testing and stability studies, and driving continuous

Formación

• Master's degree with 2+ years of pharma experience or Bachelor's with 3-5 years.
• 3+ years reviewing cGMP analytical method documents.
• Experience in analytical development and reporting.
• Knowledge of small-molecule analytical development and validation.
• Strong ability to prepare, review, and approve technical docs.

Responsabilidades

• Lead preparation, review, and approval of analytical reports and methods.
• Review data packages for release testing and stability studies.
• Collaborate with Scientists and cross-functional teams on documentation timelines.
• Support method development, validation, transfer, and lifecycle activities.
• Coordinate reporting for stability programs and data communication.
• Participate in investigations of deviations and lab events.
• Lead continuous improvement of reporting processes and data integrity.

Conocimientos

Scientific writing

Data interpretation

Project management

Cross-functional collaboration

Communication skills

Quality/regulatory awareness

Educación

Master's degree (pharma)

Bachelor's degree (pharma)

Herramientas

HPLC/UPLC

LC-MS

GC-MS

ICP-MS

Capillary electrophoresis

Analytical method validation

Descripción del empleo

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.