Senior Scientist - CMC
VistaGen Therapeutics | South San Francisco | Full-time | $120,000/year | app.trinethire.com |
Position Summary:
We are seeking a highly skilled and experienced Senior Scientist to join our Chemistry, Manufacturing, and Controls (CMC) team. The successful candidate will play various key roles, which include performing medicinal chemistry and analytical chemistry activities to support the development and manufacturing of our biopharmaceutical products.
This will be a full-time position and can be performed remotely from any location within the continental U.S. The position will report to the head of CMC.
Responsibilities
• Design and develop prototype nasal spray drug delivery systems (DDS), including formulation, process, and corresponding analytical methodologies for different molecular modalities, including steroidal molecules, as well as small molecules, at preclinical, clinical, and commercial scales.
• Analytical Testing Support: Oversee analytical testing activities conducted internally or at contract testing laboratories to ensure timely and accurate testing of raw materials, intermediates, drug substances, and drug products according to regulatory requirements and company standards.
• Develop and optimize analytical methods for evaluation of various nasal spray formulations.
• Design, develop and optimize small molecule and steroidal chemistry synthetic routes.
• Search and assess up-to-date scientific knowledge/information of various DDS/formulation approaches and maintain knowledge based on the company's interests.
• Support other activities of drug product development programs when needed.
• Technical writing: protocols, reports, SOPs, etc.
• Assimilates data and research findings outside of the Company for application to new scientific projects.
• Maintains broad knowledge of scientific principles and theories and possesses an intellectual mastery of one or more scientific areas.
• May develop an understanding of other areas and related dependencies.
• CMC Regulatory Support: Provide analytical chemistry expertise and support for regulatory submissions (e.g., IND, BLA, MAA), including preparation of drug substance sections and analytical sections for drug substance and drug product regulatory documents and responses to regulatory agencies.
• Technology Transfer and Manufacturing Support: Collaborate with cross-functional teams to ensure successful technology transfer of analytical methods and support manufacturing activities by providing analytical troubleshooting and problem-solving expertise.
• Cross-functional collaboration: Collaborate closely with colleagues in research, process development, formulation, regulatory affairs, and manufacturing to support project timelines and milestones. Including CROs, CMOs, academic partners, and regulatory agencies, to achieve project objectives and milestones. Build strong relationships and facilitate effective communication across functional areas.
Qualifications:
• Ph.D. or Master's degree in Analytical Chemistry, Medicinal Chemistry, Pharmaceutical Sciences, or related field with a minimum of 3-6 years (Ph.D.) or 6-10 years (Master's) of relevant experience in medicinal or analytical chemistry within the biopharmaceutical industry.
• Strong expertise in analytical method development, validation, and troubleshooting for biopharmaceutical products, including HPLC, LC-MS, and other relevant techniques.
• Strong expertise in synthetic medicinal chemistry
• Extensive knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) pertaining to analytical chemistry and CMC activities for biopharmaceutical products.
• Proven leadership and project management skills, with the ability to effectively lead and motivate teams in a dynamic and fast-paced environment.
• Excellent communication skills, with the ability to effectively communicate complex scientific concepts and data to cross-functional teams and external stakeholders.
• Strong problem-solving abilities, attention to detail, and a commitment to quality and compliance.
• Experience with biologics or nasal/device combination products is highly desirable.
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 $120,000 to $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.
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.
Role requires 5-10% travel.
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.
We are seeking a highly skilled and experienced Senior Scientist to join our Chemistry, Manufacturing, and Controls (CMC) team. The successful candidate will play various key roles, which include performing medicinal chemistry and analytical chemistry activities to support the development and manufacturing of our biopharmaceutical products.
This will be a full-time position and can be performed remotely from any location within the continental U.S. The position will report to the head of CMC.
Responsibilities
• Design and develop prototype nasal spray drug delivery systems (DDS), including formulation, process, and corresponding analytical methodologies for different molecular modalities, including steroidal molecules, as well as small molecules, at preclinical, clinical, and commercial scales.
• Analytical Testing Support: Oversee analytical testing activities conducted internally or at contract testing laboratories to ensure timely and accurate testing of raw materials, intermediates, drug substances, and drug products according to regulatory requirements and company standards.
• Develop and optimize analytical methods for evaluation of various nasal spray formulations.
• Design, develop and optimize small molecule and steroidal chemistry synthetic routes.
• Search and assess up-to-date scientific knowledge/information of various DDS/formulation approaches and maintain knowledge based on the company's interests.
• Support other activities of drug product development programs when needed.
• Technical writing: protocols, reports, SOPs, etc.
• Assimilates data and research findings outside of the Company for application to new scientific projects.
• Maintains broad knowledge of scientific principles and theories and possesses an intellectual mastery of one or more scientific areas.
• May develop an understanding of other areas and related dependencies.
• CMC Regulatory Support: Provide analytical chemistry expertise and support for regulatory submissions (e.g., IND, BLA, MAA), including preparation of drug substance sections and analytical sections for drug substance and drug product regulatory documents and responses to regulatory agencies.
• Technology Transfer and Manufacturing Support: Collaborate with cross-functional teams to ensure successful technology transfer of analytical methods and support manufacturing activities by providing analytical troubleshooting and problem-solving expertise.
• Cross-functional collaboration: Collaborate closely with colleagues in research, process development, formulation, regulatory affairs, and manufacturing to support project timelines and milestones. Including CROs, CMOs, academic partners, and regulatory agencies, to achieve project objectives and milestones. Build strong relationships and facilitate effective communication across functional areas.
Qualifications:
• Ph.D. or Master's degree in Analytical Chemistry, Medicinal Chemistry, Pharmaceutical Sciences, or related field with a minimum of 3-6 years (Ph.D.) or 6-10 years (Master's) of relevant experience in medicinal or analytical chemistry within the biopharmaceutical industry.
• Strong expertise in analytical method development, validation, and troubleshooting for biopharmaceutical products, including HPLC, LC-MS, and other relevant techniques.
• Strong expertise in synthetic medicinal chemistry
• Extensive knowledge of regulatory requirements and guidelines (e.g., FDA, EMA, ICH) pertaining to analytical chemistry and CMC activities for biopharmaceutical products.
• Proven leadership and project management skills, with the ability to effectively lead and motivate teams in a dynamic and fast-paced environment.
• Excellent communication skills, with the ability to effectively communicate complex scientific concepts and data to cross-functional teams and external stakeholders.
• Strong problem-solving abilities, attention to detail, and a commitment to quality and compliance.
• Experience with biologics or nasal/device combination products is highly desirable.
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 $120,000 to $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.
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.
Role requires 5-10% travel.
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.
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