Senior Production Project Manager

Our Work Matters

At Kindeva we make products that save lives, ensuring better health and well-being for patients around the world.

The Impact You Will Make 

We are seeking a results-driven Senior Manufacturing Project Manager to support manufacturing and technical operations for transdermal and inhalation drug delivery systems. This role will lead process development, scale-up, and technology transfer activities, while serving as the technical bridge between R&D, production, quality, and external partners. The successful candidate will also manage critical projects to ensure robust, complaint, and efficient manufacturing of complex dosage forms.

Key Responsibilities:

• Serve as the technical SME for transdermal patches, metered dose inhalers (MDIs), and potentially other complex drug delivery systems.
• Lead technology transfer projects from R&D to commercial manufacturing, including protocol development, execution, and documentation.
• Collaborate with formulation scientists, manufacturing teams, and quality units to ensure successful scale-up, qualification, and process validation.
• Design and execute process characterization studies / design of experiment (DOE), including mixing, coating, drying, filling, and packaging of transdermal/inhalation products.
• Investigate deviations, implement CAPAs, and perform root cause analyses to ensure ongoing process control and compliance.
• Apply project management principles to track milestones, timelines, deliverables, and resource allocation across technical projects.
• Prepare and review GMP documents such as batch records, validation protocols, SOPs, and change controls.
• Coordinate with external partners to ensure timely and compliant manufacturing execution.
• Support regulatory submissions with technical data and process documentation.
• Drive continuous improvement initiatives and apply risk assessment tools such as FMEA or Ishikawa (fishbone) diagrams.

Qualifications:

• Bachelor’s, Master’s, or Ph.D. in Chemical Engineering, Pharmaceutical Sciences, Mechanical Engineering, or related discipline.
• 5+ years of pharmaceutical industry experience
• 2+ years in project leadership or formal project management roles; PMP certification is a plus.
• In-depth understanding of cGMPs, FDA/EMA regulatory requirements, and ICH guidelines relevant to complex dosage forms.
• Strong cross-functional collaboration skills with the ability to communicate technical concepts clearly to non-technical stakeholders.
• Proficiency with project management tools (e.g., MS Project, Smartsheet) and technical software (e.g., Minitab, JMP).

Preferred Experience:

• Experience working within fast-paced contract development and manufacturing organizations (CDMOs) – highly preferred.
• Knowledge of aerosol performance testing, and transdermal property studies.
• Exposure to continuous improvement principles and tools such as Lean Manufacturing, Six-Sigma, PDCA, etc.
• Significant exposure to transdermal and/or inhalation product manufacturing.
• Hands-on experience with coating, drying, laminating, rotary converting, filling, and packaging technologies for patches and inhalers.

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