Principal Scientist, Analytical Development

VistaGen Therapeutics; South San Francisco (CA); Remote; USD 150,000 - 180,000; Full time

Job summary

A leading biotech company is seeking a Principal Scientist in Analytical Development. This role focuses on developing and validating analytical methods for drug substances and products, ensuring regulatory compliance, and managing documentation. The ideal candidate will have a PhD in Chemistry and extensive experience in the pharmaceutical industry. This full-time position offers remote work options within the U.S. and a competitive salary package, including performance-based bonuses and comprehensive healthcare benefits.

Benefits

Performance-based bonuses

Stock options

401k plan

Unlimited paid time off

Comprehensive healthcare coverage

Qualifications

• 8+ years of relevant experience in the pharmaceutical/biotech industry.
• Expertise in IND/NDA submissions and GMPs.

Responsibilities

• Oversee analytical method development and validation.
• Author and review regulatory documentation and reports.
• Manage batch release activities and ensure compliance.

Skills

Analytical Method Development

Regulatory Compliance

Technical Report Writing

Organizational Skills

Communication

Education

PhD in Chemistry

Tools

SharePoint

Job description

The Principal Scientist, Analytical Development (CMC) role is pivotal in ensuring the development, validation, and regulatory readiness of drug substance (DS) and drug product (DP) analytical methods, as well as overseeing the document organization, batch release, and regulatory submissions. The ideal candidate is highly skilled and detail-oriented with a strong background in analytical development, regulatory compliance, and technical report writing.

This is a full-time position and may be performed remotely from any location within the continental U.S. The position will report to the SVP and Head of CMC.

Key Duties & Responsibilities :

Key responsibilities of this role include, but are not limited to :

Analytical Method Development & Validation

• Design, review, and approve DS and DP method transfer, method validation, method development, and test method documentation.
• Author and review IND / NDA sections related to DS & DP analytical methods.
• Evaluate and analyze SPE method data for placebo fingerprinting and method bridging.

Regulatory Documentation & Reporting

• Serve as the Module 3 authoring resource, including creating tables and performing data quality assessments (DQA).
• Author and review development reports, technical reports, and related documentation for regulatory submissions.
• Review stability data and author corresponding IND / NDA sections.

Operational & Quality Oversight

• Track retest dates for impurities, reference standards, and APIs to ensure compliance.
• Oversee DP batch release activities, including reviewing Company documentation to confirm adherence to GMPs and checklist completion.
• Conduct protocol and technical report reviews to ensure accuracy and compliance.

Documentation & Data Management

• Maintain and organize analytical documents on SharePoint, ensuring the latest versions are accessible.
• Review and approve documentation related to stability, testing methods, and regulatory submissions.
• Partner cross-functionally with internal and external stakeholders to advance analytical method development.
• Implement best practices for documentation and analytical development processes.

Qualifications :

• PhD in Chemistry, Analytical Chemistry, or related field, with 8+ years of relevant experience in the pharmaceutical / biotech industry (or equivalent combination of education and experience).
• Expertise in analytical method development, validation, and regulatory requirements (IND / NDA submissions).
• Strong knowledge of GMPs, ICH guidelines, and stability study protocols.
• Proficiency in SharePoint for document management.
• Excellent organizational, communication, and technical writing skills.
• Proven ability to manage multiple priorities and meet deadlines in a fast-paced environment.
• Experience with SPE methods and placebo fingerprinting analysis.
• Previous experience in CMC roles or supporting regulatory submissions.

Compensation and Benefits

What we offer :

• Industry competitive compensation
• Performance-based bonuses
• Stock options
• Employee Stock Purchase Plan
• 401k plan
• A collaborative and innovative work environment at the forefront of biotech advancements

Give your best, live wholesomely :

• Comprehensive healthcare coverage, including medical, dental, and vision plans for employees and dependents
• FSA and HAS
• Basic Life Insurance 2x Earnings and AD&D
• Employee Assistance Program
• Healthcare advocates group to help navigate the healthcare system

Work-life balance :

• Unlimited paid time off
• Paid holidays
• Winter shutdown
• Casual work environment

We uphold the ethos of work-life harmony, where enjoyment is woven into our fundamental values of integrity, teamwork, compassion, and excellence.

The anticipated salary range for candidates who will work remotely is $150,000-$180,000 per year. The final pay offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and years of experience within the job, the type of years and experience within the industry, education, etc.

Provided they meet all eligibility requirements under the applicable plan documents, employees (and their eligible dependents) will be eligible to enroll in group healthcare plans that offer medical, dental, vision, and basic life insurance. Employees also will be able to enroll in our company's 401k plan provided they meet plan requirements. Employees will also enjoy paid holidays throughout the calendar year, subject to relevant terms outlined in the employee handbook. Eligibility requirements for these benefits will be controlled by applicable plan documents.

Physical Demands :

The physical demands described here are representative of those that must be met by an employee to perform the essential functions of this job successfully. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to talk or hear. The employee is frequently required to sit.

The employee is required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. The transition from standing and sitting often.

Specific vision for this job includes close vision, distance vision, color vision, peripheral vision, depth perception, and ability to adjust focus.

This position requires the ability to lift and / or move up to 25 pounds occasionally.

Evening and weekend work as necessary. Flexible hours (domestic time zones) may be required in this remote environment.

DISCLAIMER

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as general description of benefits and other compensation and it is not a substitute for applicable plan documents or company policies. They are not intended to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified.

EEO Employer : VISTAGEN THERAPEUTICS, INC., is an equal opportunity employer; all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected classification.

All Employee's have rights under Federal Employment Laws and link to the three posters : Family and Medical Leave Act (FMLA) Poster Know Your Rights Poster; and Employee Polygraph Protection Act (EPPA)

Headquartered in South San Francisco, CA, Vistagen Therapeutics, Inc. (NASDAQ : VTGN) is a late clinical-stage company leveraging its pioneering neuroscience and deep understanding of nose-to-brain neurocircuitry to develop and commercialize a broad and diverse pipeline of intranasal product candidates called pherines. Each pherine product candidate in Vistagen's neuroscience pipeline is designed to rapidly activate olfactory system and rain neurocircuitry to achieve desired therapeutic benefits and differentiated safety without requiring systemic absorption or binding to neurons in the brain. Vistagen's neuroscience pipeline also includes an oral prodrug, AV-101, with potential to impact certain neurological conditions involving the NMDA receptor. Vistagen is passionate about developing transformative treatment options to improve the lives of individuals underserved by the current standard of care for multiple highly prevalent disorders, including social anxiety disorder, major depressive disorder, and vasomotor symptoms (hot flashes) associated with menopause. Connect at www.vistagen.com.

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