[Remote] Director of Drug Product Development at Roivant Sciences

United States

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Biotechnology, PharmaceuticalsIndustries

Requirements

15+ years of experience in inhalation product development (preferably dry powder inhalation)
Demonstrated success advancing an inhalation product through late-stage development (Phase 2b/3) and into registration
Hands-on experience with formulation, process scale-up, drug-device compatibility, and aerodynamic performance testing (APSD, delivery)

Responsibilities

Serve as the Drug Product Technical Lead for the inhalation dosage form, accountable for product performance, manufacturability, and lifecycle management
Lead Phase 3 process characterization, validation, and registration batch execution at CDMOs
Provide scientific oversight of formulation development, device compatibility, and container–closure system
Partner with other functional area leads to ensure successful method validation, product specifications, and stability studies to support regulatory filings
Partner with Quality, Regulatory, and Supply Chain to ensure GMP compliance and pre-approval inspection (PAI) readiness
Represent drug product in CMC team meetings, regulatory submissions (Module 3), and health authority interactions
Manage technology transfer when needed, manufacturing documentation, and process validation protocols/reports
Collaborate closely with other functional areas (drug substance, analytical development, and QA) to ensure a robust control strategy
Provide technical guidance and mentoring to junior staff or matrixed contributors as needed

Skills

Key technologies and capabilities for this role

Drug Product DevelopmentManufacturing Scale-upDry Powder InhalationCDMO ManagementPhase 2/3 Clinical DevelopmentCommercial ManufacturingCross-functional Team LeadershipDrug SubstanceQuality AssuranceRegulatory Affairs

Questions & Answers

Common questions about this position

What is the primary focus of this role?

The role focuses on driving the development, scale-up of Phase 3 and commercial manufacturing of a dry powder inhaled small-molecule program through external CDMOs, managing late-stage clinical development (Phase 2/3) and transition to commercial manufacturing.

What salary or compensation is offered for this position?

This information is not specified in the job description.

Is this position remote or does it require office presence?

This information is not specified in the job description.

What key skills and experience are required for the ideal candidate?

The ideal candidate needs a deep understanding of inhalation drug product process development, technical transfer, regulatory requirements, CDMO management, and a proven track record in managing and driving project success, while being detail-driven.

What does the role entail in terms of team leadership and collaboration?

The successful candidate will lead cross-functional teams involving drug substance, clinical, non-clinical, quality and regulatory partners, and work closely with external partners to ensure timely delivery of high-quality drug product.

Roivant Sciences

Develops biopharmaceuticals and RNA therapeutics

About Roivant Sciences

Roivant Sciences develops and delivers medicines and technologies aimed at improving patient health, focusing on drug candidates for genetic disorders and RNA therapeutics. The company operates in the biopharmaceutical market, which involves creating drugs from biological sources. Roivant's unique business model combines in-house development with strategic partnerships, allowing it to build a strong pipeline of drug candidates and utilize advanced technologies to meet medical needs. A key subsidiary, Genevant, specializes in RNA therapeutics, employing proprietary delivery platforms for mRNA, RNAi, and gene editing to treat specific diseases. Roivant generates revenue through drug development, licensing agreements, and partnerships, with the goal of bringing innovative treatments to market efficiently.

New York City, New YorkHeadquarters

2014Year Founded

$1,750.9MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

201-500Employees

Benefits

Remote Work Options

Risks

Integration challenges from Dermavant acquisition may disrupt operations and delay development.

Regulatory hurdles in Pulmovant collaboration with Bayer could impede progress.

Failure of lupus drug brepocitinib may lead to financial losses and investor concerns.

Differentiation

Roivant Sciences focuses on late-stage drug candidates, reducing development time and cost.

The company builds Vants, nimble biotech firms, to enhance drug development efficiency.

Roivant leverages RNA therapeutics, including mRNA and RNAi, for innovative treatments.

Upsides

Roivant's acquisition of Dermavant expands its dermatology portfolio and therapeutic areas.

Strategic partnerships with Bayer and Roche accelerate drug development and market entry.

Increased investment from financial institutions highlights confidence in Roivant's growth potential.

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