Director, Process Chemistry - Drug Substance (CMC)

ABOUT THIS ROLE:

The Director, Process Chemistry, Drug Substance (CMC) will serve as a technical subject matter expert responsible for drug substance process development from clinical development through commercialization. The successful candidate needs to demonstrate a proven track record of working in a remote virtual environment with contract development & manufacturing organizations (CDMOs) to deliver manufacturing processes that can be scaled to batch sizes sufficient to support fast-paced clinical development programs. Using strategic thinking, the individual must be able to develop and defend a process design space. This individual will play a vital role in the development, production, and quality control of drug substance manufacturing. Responsibilities will revolve around the manufacturing and characterization of drug substances, ensuring compliance with regulatory requirements and industry standards. The successful candidate will work closely with cross-functional teams, including CMC, analytical chemistry, quality assurance, and regulatory affairs personnel.

This individual will oversee drug substance process development, manufacturing support, process validation, analytical method development and validation, tech-transfer, scale-up, and manufacturing activities related to Vistagen’s multiple ongoing late-stage clinical programs.

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

RESPONSIBILITIES

Drug Substance Process Development: Collaborate with CDMOs to design and optimize drug substance manufacturing processes. Design experiments, analyze data, and recommend process improvements to enhance yield, purity, and scalability.
Manufacturing Support: Oversee non-GMP and GMP drug substance manufacturing operations, including process setup, equipment qualification, and production batch execution. Ensure adherence to Good Manufacturing Practices (GMP) and standard operating procedures (SOPs), where appropriate.
Process Validation: Design and execute process validation studies to demonstrate the robustness and reproducibility of drug substance manufacturing processes. Analyze data, identify deviations, and propose corrective actions to ensure process reliability.
Analytical Method Development: Work with analytical scientists at CDMOs CROs to develop and phase-appropriately validate analytical methods for drug substance characterization, batch release and stability studies. Collaborate with the CDMO regarding the selection and qualification of analytical instruments and technologies.
Quality Control: Establish and maintain quality control procedures for incoming raw materials receipt and drug substance manufacturing. Perform in-process and final product testing, review analytical data, and ensure compliance with specifications and regulatory requirements.
Documentation and Compliance: Prepare and review quality assurance and technical documents, including batch records, protocols, reports, deviations, out of specification results and regulatory submissions. Ensure relevant data is captured in reports provided by external CDMOs.
Ensure compliance with relevant regulatory guidelines, such as FDA, EMA, and ICH.
Continuous Improvement: Identify opportunities for process optimization, cost reduction, and efficiency enhancement. Implement lean manufacturing principles and participate in continuous improvement initiatives.
Cross-Functional Collaboration: Collaborate with external CDMOs as well as internal departments, such as process development, formulation, and regulatory affairs, to ensure alignment and integration of drug substance activities within the overall drug development process.
Technical Problem Solving: Solve technical issues relating to external drug substance manufacturing by providing leadership within the CMC team.
Technical Proficiency: Responsible for drug substance process design, optimization, scale-up, technology transfer, validation, and maintaining the lifecycle of the product. Serves as a technical resource to guide in strategic decision making and conducts analysis of technical and conceptual risk; identifies and champions operational processes and mitigation strategies.
Regulatory Awareness: Ensure that the drug substance development is compliant with both relevant regulations and regulatory commitments. Author relevant module 3 regulatory documents such as INDs, annual reports and NDAs. A strong understanding and knowledge of CGMP/ICH regulations and an ability to apply them to drug substance development and manufacturing.

QUALIFICATIONS:

Bachelor's or Master's degree in chemistry, chemical engineering, pharmaceutical sciences, or a related field with 8-10 years experience. A Ph.D. degree is preferred but is not required.
Strong fundamental knowledge of organic chemistry and steroid chemistry, including synthesis, purification, and characterization techniques.
Familiarity with regulatory requirements and quality standards governing drug substance development and manufacturing (e.g., GMP, FDA, ICH guidelines).
Advanced proficiency in analytical techniques commonly used for drug substance characterization (e.g., HPLC, GC, NMR, mass spectrometry).
Experience with process validation and statistical analysis.
Excellent leadership, teamwork and problem-solving skills with acute attention to detail.
Effective communication, collaboration and interpersonal skills to foster effective interaction with cross-functional teams.
Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced environment.

Proficiency with utilizing typical literature searching techniques to solve organic chemistry problems.
Able to make international and domestic travel including virtual meetings with international vendors. Approximately 10 – 15 % travel expected.

What we offer:

Industry competitive compensation
Performance-base 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 & AD&D
Employee Assistance Program
Healthcare advocates group to help navigate the healthcare system

Work-Life Balance:

Unlimited paid time off
Flexible work schedule
Remote work option
Paid Holidays
Mental Health Days & Observances
Winter shut-down
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 $180,000 to $225,000 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.

The above statements are intended to describe the general nature and level of work performed by employees assigned to this classification as well as a 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.

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 the 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.

Disclaimer

This is intended to provide a general description of the job responsibilities, benefits and other compensation and 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.

About Us:

Vistagen (Nasdaq: VTGN) is a late clinical-stage biopharmaceutical company aiming to transform the treatment landscape for individuals living with anxiety, depression, and other CNS disorders. Vistagen is advancing therapeutics with the potential to be faster-acting, and with fewer side effects and safety concerns than those currently available for the treatment of anxiety, depression, and multiple CNS disorders. Vistagen’s pipeline includes six clinical-stage product candidates, including fasedienol (PH94B), itruvone (PH10), PH80, PH15, and PH284, each an investigational agent belonging to a new class of drugs known as pherines, as well as AV-101, which is an oral prodrug of an antagonist of the N-methyl-D aspartate receptor (NMDAR). Pherines are neuroactive nasal sprays designed with an innovative proposed mechanism of action that activates chemosensory neurons in the nasal cavity and can beneficially impact key neural circuits in the brain without systemic absorption or direct activity on neurons in the brain.

Vistagen is passionate about transforming mental health care and redefining what is possible in the treatment of anxiety, depression, and several other CNS disorders.

At Vistagen, we emphasize that mental health is foundational to living vibrant and healthy lives. We believe that healthy minds create healthy communities, and our core goal at Vistagen is to radically improve mental health and well-being worldwide – One Mind at a Time. We are change-makers committed to improving lives by developing innovative, science-based mental health care medicines with the potential to make the impossible, possible - to empower and support patients and their caregivers to achieve faster-acting efficacy without the side effects and safety concerns associated with current treatment options for anxiety and depression.

Vistagen Therapeutics, Inc. is committed to equal employment opportunity, regardless of age, ancestry, color, disability (mental and physical), exercising the right to family care and medical leave, gender, gender expression, gender identity, genetic information, marital status, medical condition, military or veteran status, national origin, political affiliation, race, religious creed, sex (includes pregnancy, childbirth, breastfeeding, and related medical conditions), and sexual orientation.