Apply on Employer Site

Insmed Incorporated · 3 hours ago

Vice President, Product Development - CMC, Small Molecules

Headquarters, NJ

Full-time

Hybrid

Director/Executive

$329K/yr - $398K/yr

15+ years exp

Insmed Incorporated is a global biopharmaceutical company dedicated to transforming the lives of patients with serious and rare diseases. They are seeking a highly experienced Vice President of Product Development to lead Chemistry, Manufacturing, and Controls (CMC) activities for their small molecule pipeline, ensuring compliance with regulatory standards and overseeing drug development initiatives.

BiotechnologyMedicalPharmaceutical

Growth Opportunities

Responsibilities

Provide strategic leadership by defining and executing the CMC strategy for all small molecule programs throughout their lifecycle, from preclinical development through commercialization

Serve as a key member of the Technical Operations leadership team and contribute significantly to overall product development strategy

Lead both drug substance (API) and drug product development initiatives, including formulation development, process chemistry, and scale-up operations

Oversee analytical method development and validations and have experience in combination devices

Ensure manufacturing readiness for both clinical and commercial supply chains

Support global CMC regulatory strategies that align with clinical and commercial objectives

Author, review, and approve CMC sections of regulatory submissions including INDs, NDAs/MAAs, and other required documentation

Ensure compliance with ICH, FDA, EMA, PMDA and other international regulatory guidelines

Build and lead a high-performing CMC team while managing relationships with external manufacturing partners and CDMOs to ensure reliable clinical supply and maintain quality standards

Partner with Discovery, Clinical Development, Quality, Regulatory Affairs, Operations, and Commercial teams to ensure seamless program advancement

Provide technical expertise and due diligence support for business development opportunities

Qualification

CMC developmentSmall molecule pharmaceuticalsRegulatory submissionsProcess chemistryFormulation developmentAnalytical developmentLeadership skillsExternal partner managementStrategic thinkingCommunication skillsTeam management

Required

Ph.D. or advanced degree in Chemistry, Pharmaceutical Sciences, Chemical Engineering, or related field

15+ years of progressive experience in CMC development for small molecule pharmaceuticals, with at least 7 years in senior leadership

Proven track record in advancing programs from preclinical to commercial launch

Deep knowledge of small molecule process chemistry, formulation, and analytical development

Demonstrated success in regulatory submissions and global CMC regulatory requirements

Experience managing external partners (CMOs/CDMOs)

Strong leadership, strategic thinking, and communication skills

Benefits

Comprehensive medical, dental, and vision coverage and mental health support, annual wellbeing reimbursement, and access to our Employee Assistance Program (EAP)

Generous paid time off policies, fertility and family-forming benefits, caregiver support, and flexible work schedules with purposeful in-person collaboration

401(k) plan with a competitive company match, annual equity awards, and participation in our Employee Stock Purchase Plan (ESPP), and company-paid life and disability insurance

Company Learning Institute providing access to LinkedIn Learning, skill building workshops, leadership programs, mentorship connections, and networking opportunities

Employee resource groups, service and recognition programs, and meaningful opportunities to connect, volunteer, and give back

Company

Insmed Incorporated

Insmed is a people-ﬁrst global biopharmaceutical company striving to deliver ﬁrst- and best-in-class therapies to transform the lives of patients facing serious diseases.

Founded in 1988

Bridgewater, New Jersey, USA

1001-5000 employees