Associate Director, Drug Substance, Pulmovant at Pulmovant | chakrie

Requirements

Ph.D. or M.S. in Organic Chemistry, Chemical Engineering, Pharmaceutical Sciences, or a closely related discipline
8+ years of progressive experience in drug substance development and manufacturing within the pharmaceutical industry, focusing on late-stage 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
Ability to work in a fast-paced, cross-functional environment and influence internal and external stakeholders
In-depth knowledge of material sciences and solid-state characterization, including ssNMR, XRPD, and advanced spectroscopic techniques
Experience with inhaled/inhalation products is a plus

Strong written and verbal communication skills, with a proven ability to present complex technical data clearly and interact effectively with regulatory authorities, global CDMOs, and senior corporate leadership
Proven, hands-on experience driving drug substance chemistry, manufacturing, and control (CMC) activities directly supporting a successful NDA submission
Prior experience preparing for, hosting, or managing a successful regulatory Pre-Approval Inspection (PAI)
Recognized Subject Matter Expert (SME) in late-stage process characterization, including Quality by Design (QbD), PAR/NOR establishment, Fate and Purge of impurities studies, and ICH M7/nitrosamine safety assessments
Highly fluent and well-versed in global ICH guidelines for drug substance development and manufacturing
Pulmovant provides equal employment opportunities to all employees and applicants for employment and prohibits discrimination and harassment of any type without regard to race
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!

Responsibilities

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Skills & expertise

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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Salary & benefits

A clear overview of what is expected, written by the people who posted it, with every detail you need to decide.

Qualifications, experience and the skills that matter most, along with anything that would make you stand out.

Practical next steps, the documents to prepare and the dates to keep in mind before you apply or get in touch.

Contact details, links to the official source and the notes our team adds after checking each listing by hand.

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