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Juniper Biosciences · 3 weeks ago

Head of Program Management

Bridgewater, NJ

Full-time

Hybrid

Director/Executive

7+ years exp

Juniper Biosciences is a radiopharmaceutical company focused on the discovery, development, and commercialization of novel diagnostic and therapeutic agents. The Head Program Manager will lead cross-functional pharmaceutical development programs, ensuring projects are delivered on time, within scope, and in alignment with company strategy.

ManufacturingMedicalPharmaceutical

Hiring Manager

Alex Agnoletto

Responsibilities

Lead end-to-end planning and execution of drug development programs (formulation, process scale-up, tech transfer, validation, and commercial readiness)

Develop and maintain integrated project plans, timelines, and budgets; proactively identify risks, issues, and mitigation strategies

Facilitate cross-functional decision-making and ensure alignment between internal stakeholders and external partners

Track and report program status, risks, and milestones to senior leadership through dashboards and regular governance meetings

Coordinate and contribute to the CMC sections of NDAs, ANDAs, and other regulatory submissions (e.g., IND amendments, supplements)

Drive data collection, gap assessments, and documentation from internal teams and CMOs/CDMOs to support high-quality submissions

Partner with Regulatory Affairs to respond to FDA’s queries and ensure timely resolution of CMC-related issues

Serve as primary program interface with global CMOs/CDMOs for drug product and/or drug substance manufacturing

Lead tech transfer activities, ensuring clear scope, timelines, and success criteria are defined and met

Oversee external project plans, change controls, deviations, and performance metrics; escalate and resolve issues impacting supply or quality

Support vendor selection, due diligence, and ongoing relationship management in collaboration with Technical Operations, Quality, and Procurement

Collaborate closely with formulation scientists and process development teams to translate lab processes into scalable, robust manufacturing processes

Ensure formulation and process development activities are aligned with target product profile (TPP), regulatory expectations, and commercial needs

Coordinate development and validation of analytical methods and stability studies in support of product development and filing strategies

Implement and continuously improve program management best practices, tools, and templates

Lead risk management activities (risk registers, mitigation plans, scenario planning)

Ensure compliance with GMP, ICH, and relevant global regulatory requirements in all program activities

Qualification

Program ManagementRegulatory SubmissionsFormulation DevelopmentCMO/CDMO ManagementProject Management ToolsPharmaceutical DevelopmentGMP ManufacturingFDA GuidelinesCommunicationCollaboration & LeadershipProblem-SolvingOrganizational Skills

Required

Bachelor's degree in pharmacy, Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field required

7+ years of experience in the pharmaceutical/biopharmaceutical industry/FDA, with at least 3–5 years in program or project management roles

Proven track record of contributing to or leading NDA and/or ANDA submissions (CMC sections strongly preferred)

Direct experience working with global CMOs/CDMOs for drug product and/or drug substance, including tech transfer and commercial or late-stage manufacturing

Hands-on or closely integrated experience in formulation development (solid oral, sterile, semi-solid, or other dosage forms)

Demonstrated success managing cross-functional teams (e.g., R&D, CMC, QA, QC, Regulatory, Supply Chain)

Strong skills in timeline development, critical path analysis, resource planning, and risk management; experience with project management tools (e.g., MS Project, Smartsheet) a plus

Solid understanding of pharmaceutical development, CMC principles, formulation science, and GMP manufacturing

Working knowledge of FDA and ICH guidelines and regulatory expectations for NDAs/ANDAs and related CMC requirements

Excellent written and verbal communication skills; able to synthesize complex technical topics into clear, concise updates for diverse audiences

Strong interpersonal skills; able to influence without direct authority and build effective relationships with internal teams and external partners worldwide

Proven ability to anticipate issues, analyze root causes, and drive data-driven solutions under time pressure

High attention to detail with the ability to manage multiple programs and priorities simultaneously