Roivant’s mission is to systematically reduce the time, cost, and risk of delivering new medicines to market by accelerating the development of promising drug candidates to improve the lives of patients and their families. Since its inception in 2014, Roivant has achieved the following critical milestones in support of its vision: built over 20 portfolio companies (Vants); 5 successful IPOs; $3B partnership with global pharma; pipeline of over 40 assets across various modalities and therapeutic areas; 9 successful phase 3 readouts since 2019; launched VTAMA®, (tapinarof) cream, 1%, for the topical treatment of plaque psoriasis in adults. Building upon this track record of establishing a robust pipeline through in-licensing and acquisition of novel assets and technology platforms, Roivant is currently building new capabilities in drug discovery and expanding upon existing development disciplines to become the leading tech-enabled pharmaceutical company.
As the centralized engine for innovation and development the Roivant R&D team is responsible for: 1) discovery efforts focused on integrating computational and medicinal chemistry methods in order to establish R&D leadership positions in oncology, immunology and rare diseases; 2) working hand in hand with Business Development to establish the scientific rationale and initial development strategy for in-licensing opportunities; 3) providing tactical and strategic R&D support to stand up new portfolio companies (Vants) and advance development efforts across the portfolio.
Position Summary
Roivant is seeking a highly skilled and experienced Director of Analytical Chemistry to join our team and lead development activities focused on inhalation products. The Director of Analytical Chemistry will play a pivotal role in ensuring the quality, integrity, stability, and regulatory compliance of our inhaled drug products and devices. This role involves close collaboration with cross-functional teams, including formulation development, CMC, regulatory affairs, quality, and external partners.
Responsibilities
- Lead and manage the development, validation, and execution of phase-appropriate analytical methods with internal and external partners to assess the quality and performance of inhaled drug substances, drug products, devices. and combinations thereof from development to commercialization.
- Design and oversee analytical strategies for evaluating the performance and stability of inhalation combination products, in collaboration with the formulation development team.
- Provide technical leadership and expertise in analytical chemistry to guide the development and optimization of methods for characterizing drug substances and drug products.
- Collaborate with external contract development and manufacturing organizations (CDMOs) to ensure the transfer and validation of analytical methods for drug substance and drug product manufacturing.
- Work closely with regulatory affairs and contract organizations to ensure that analytical methods and data meet regulatory requirements for drug product submissions, including NDA filings.
- Lead efforts to establish and maintain a comprehensive analytical control strategy for inhaled drug products, ensuring compliance with cGMP regulations and industry best practices.
- Participate in cross-functional teams to align analytical strategies with overall product development goals and timelines.
- Oversee the management of CROs, resources, and budgets to support analytical chemistry activities.
- Provide subject matter expertise during regulatory inspections, audits, and interactions related to analytical chemistry and quality control.
- Collaborate with the quality team to ensure proper investigation and resolution of any analytical-related deviations or out-of-specification results
Skills, Qualifications, and Requirements
- PhD or equivalent in Analytical Chemistry, Pharmaceutical Sciences, or a related discipline with a strong background in analytical method development and validation. Extensive experience in analytical method development, validation, and application in the pharmaceutical industry, with a focus on inhaled drug products and combination devices.
- Profound knowledge of current regulatory guidelines (FDA, EMA, etc.) and cGMP requirements related to analytical chemistry and quality control for drug products.
- Demonstrated leadership experience in managing and mentoring analytical chemistry teams.
- Strong communication and collaboration skills to effectively work across cross-functional teams and external partners.
- Experience in engaging with regulatory authorities during inspections and inquiries related to analytical chemistry and quality control aspects.
- Prior experience in contributing to regulatory submissions, including providing technical content for drug product sections.
- Experience with device master files is preferred.
- Strategic thinking and the ability to align analytical strategies with overall product development and regulatory goals.
- Proven ability to manage timelines, budgets, and resources for analytical chemistry projects.
- Familiarity with various analytical techniques such as HPLC, GC, spectroscopy, particle size analysis, and dissolution testing.
- 5+ years of experience in a leadership role within analytical chemistry, preferably in the context of inhalation drug products.
Roivant Sciences 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.
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