Pulmovant, Inc.
Director/Senior Director, Drug Substance Development, Pulmovant
Pulmovant, Inc., Waltham, Massachusetts, United States, 02254
Pulmovant is a Roivant-backed clinical-stage biotechnology company developing innovative therapies for patients suffering from pulmonary diseases. Pulmovant’s first program, mosliciguat is designed to provide an effective, once-daily, inhaled treatment option for patients with pulmonary hypertension (PH). Mosliciguat is a novel, potential first-in-class, sGC activator with a differentiated mechanism that may have broad applicability across the PH spectrum.
Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial will begin this year.
As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need.
Summary:
Pulmovant is seeking a Director/Senior Director of Drug Substance Development and Manufacturing to help drive the development, scale-up, and commercial manufacturing of drug substances through external CDMOs. This role focuses on managing late-stage clinical development activities (Phase 2/3) and ensuring a smooth transition to commercial manufacturing.
This is an exciting and visible role for a highly qualified and motivated individual. The successful candidate will lead cross-functional teams involving drug product, clinical, non-clinical, quality and regulatory partners, and work closely with external partners to ensure timely delivery of high-quality drug substance in compliance with global regulatory standards.
The ideal candidate will be detail driven and have a deep understanding of drug substance process development, technical transfer, regulatory requirements, and CDMO management and a proven track record in managing and driving project success.
Key Duties and Responsibilities
Drug Substance Development:
Lead the strategy for drug substance development from late-stage clinical development through commercialization.
Collaborate with internal CMC, regulatory, and Quality partners to define robust and scalable processes for drug substance production.
Oversee the optimization, scale-up, and validation of manufacturing processes at CDMOs.
Serve as the primary point of contact for drug substance activities & information, ensuring effective communication and issue resolution.
CDMO Management:
Manage relationships with CDMOs for drug substance development and manufacturing activities.
Negotiate contracts, timelines, and budgets with CDMOs and ensure alignment with company goals and project milestones.
Monitor performance of CDMOs and ensure compliance with contractual obligations, quality standards, and regulatory requirements.
Technical Transfer and Scale-Up:
Drive technical transfer of drug substance processes between external CDMOs, ensuring smooth and efficient transition.
Lead scale-up activities and process validation in alignment with regulatory requirements (e.g., FDA, EMA).
Oversee the establishment of commercial scale manufacturing processes, ensuring consistency and robustness.
Regulatory and Quality Compliance:
Ensure drug substance development and manufacturing processes comply with global regulatory standards, including cGMP guidelines.
Work closely with Regulatory Affairs to prepare CMC sections for regulatory submissions (e.g., NDA) and respond to agency inquiries.
Project/Resource Management:
Develop and execute project plans, including timelines, budgets, and resource allocation for drug substance development and manufacturing.
Provide regular updates to senior leadership on project status, risks, and mitigation strategies.
Manage budget for drug substance development and manufacturing activities, ensuring cost-effective delivery of high-quality materials.
Forecast future manufacturing needs and ensure appropriate CDMO capacity and resources are secured.
Education and Experience
D. or M.S. in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline.
10+ years of experience in drug substance development and manufacturing within the pharmaceutical industry, with significant experience in late-stage clinical development and commercialization.
Strong background in managing CDMO relationships and outsourcing strategies.
Demonstrated experience in process development, scale-up, and technical transfer.
Knowledge of global regulatory requirements and cGMP compliance.
Excellent project management, organizational, and leadership skills.
Strong negotiation skills and the ability to manage multiple CDMO partnerships simultaneously.
Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders.
Strong written and verbal communication skills, with the ability to interact effectively with regulatory authorities, CDMOs, and senior leadership.
Experience with aerosol/DPI development is preferred.
Experience in drug substance activities for an NDA submission preferred.
Prior experience preparing for or managing a successful pre-approval inspection (PAI) preferred.
Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!
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Mosliciguat has been extensively characterized across a robust Phase 1 program with 170 participants dosed to date including patients with PH in the Phase 1b ATMOS study which has produced highly compelling and clinically meaningful efficacy data, as well as a favorable safety profile. Enrollment in a phase 2 trial will begin this year.
As part of the Roivant family of companies, Pulmovant leverages the power of collaboration and innovation to drive progress. Roivant specializes in developing transformative medicines at an accelerated pace through the launch of nimble biopharmaceutical and health technology entities, each meticulously tailored to address a specific medical need.
Summary:
Pulmovant is seeking a Director/Senior Director of Drug Substance Development and Manufacturing to help drive the development, scale-up, and commercial manufacturing of drug substances through external CDMOs. This role focuses on managing late-stage clinical development activities (Phase 2/3) and ensuring a smooth transition to commercial manufacturing.
This is an exciting and visible role for a highly qualified and motivated individual. The successful candidate will lead cross-functional teams involving drug product, clinical, non-clinical, quality and regulatory partners, and work closely with external partners to ensure timely delivery of high-quality drug substance in compliance with global regulatory standards.
The ideal candidate will be detail driven and have a deep understanding of drug substance process development, technical transfer, regulatory requirements, and CDMO management and a proven track record in managing and driving project success.
Key Duties and Responsibilities
Drug Substance Development:
Lead the strategy for drug substance development from late-stage clinical development through commercialization.
Collaborate with internal CMC, regulatory, and Quality partners to define robust and scalable processes for drug substance production.
Oversee the optimization, scale-up, and validation of manufacturing processes at CDMOs.
Serve as the primary point of contact for drug substance activities & information, ensuring effective communication and issue resolution.
CDMO Management:
Manage relationships with CDMOs for drug substance development and manufacturing activities.
Negotiate contracts, timelines, and budgets with CDMOs and ensure alignment with company goals and project milestones.
Monitor performance of CDMOs and ensure compliance with contractual obligations, quality standards, and regulatory requirements.
Technical Transfer and Scale-Up:
Drive technical transfer of drug substance processes between external CDMOs, ensuring smooth and efficient transition.
Lead scale-up activities and process validation in alignment with regulatory requirements (e.g., FDA, EMA).
Oversee the establishment of commercial scale manufacturing processes, ensuring consistency and robustness.
Regulatory and Quality Compliance:
Ensure drug substance development and manufacturing processes comply with global regulatory standards, including cGMP guidelines.
Work closely with Regulatory Affairs to prepare CMC sections for regulatory submissions (e.g., NDA) and respond to agency inquiries.
Project/Resource Management:
Develop and execute project plans, including timelines, budgets, and resource allocation for drug substance development and manufacturing.
Provide regular updates to senior leadership on project status, risks, and mitigation strategies.
Manage budget for drug substance development and manufacturing activities, ensuring cost-effective delivery of high-quality materials.
Forecast future manufacturing needs and ensure appropriate CDMO capacity and resources are secured.
Education and Experience
D. or M.S. in Chemical Engineering, Chemistry, Pharmaceutical Sciences, or a related discipline.
10+ years of experience in drug substance development and manufacturing within the pharmaceutical industry, with significant experience in late-stage clinical development and commercialization.
Strong background in managing CDMO relationships and outsourcing strategies.
Demonstrated experience in process development, scale-up, and technical transfer.
Knowledge of global regulatory requirements and cGMP compliance.
Excellent project management, organizational, and leadership skills.
Strong negotiation skills and the ability to manage multiple CDMO partnerships simultaneously.
Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders.
Strong written and verbal communication skills, with the ability to interact effectively with regulatory authorities, CDMOs, and senior leadership.
Experience with aerosol/DPI development is preferred.
Experience in drug substance activities for an NDA submission preferred.
Prior experience preparing for or managing a successful pre-approval inspection (PAI) preferred.
Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws.
We will not accept unsolicited resumes nor outreach from agencies. Please do not send agency resumes to our website or Roivant Sciences and affiliated employees. Thanks!
#J-18808-Ljbffr