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What is the difference between Director Cdmo vs Director Regulatory Affairs?

AspectDirector CdmoDirector Regulatory Affairs
Required CredentialsAdvanced degree in life sciences, engineering, or related field; industry experienceAdvanced degree in life sciences, law, or related field; regulatory certifications often preferred
Work EnvironmentContract manufacturing organizations, pharmaceutical or biotech companiesPharmaceutical companies, biotech firms, regulatory agencies
Employer & Industry UsageUsed in contract manufacturing and development settingsUsed in companies overseeing product approval and compliance

The main difference is that a Director Cdmo focuses on managing contract manufacturing and development projects, while a Director Regulatory Affairs handles regulatory compliance and approval processes. Both roles require advanced degrees and industry experience but serve different functions within the pharmaceutical and biotech sectors.

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Infographic showing various Director Cdmo job openings in the United States as of June 2026, with employment types broken down into 1% As Needed, 84% Full Time, 13% Part Time, and 2% Contract. Highlights an 92% Physical, 1% Hybrid, and 7% Remote job distribution.

Director, Manufacturing Operations - NY

Panther Life Sciences Corporation

New York, NY • On-site

$170K - $220K/yr

Full-time

Medical, Dental, Vision, Life, PTO

Posted 9 days ago

Job description

About Panther:
Panther is unlocking the tremendous biological powers of our skin to deliver a wide range of shelf-stable treatments. Panther's precisely engineered microarray patches (MAPs) are focused on: i) Skin Health, treating coloration, wrinkles, scars, wounds, etc.; and ii) Therapeutics, treating ailments along the immunological spectrum, including infectious diseases, cancer, allergies and autoimmune diseases.
Panther's MAPs are designed to deliver superior efficacy and high levels of usage/adherence, and enable automated data integration across its ecosystem of consumers, providers and treatment developers. Panther's AI enabled platform provides personalized customer care and accelerated treatment discovery. Via advanced GMP manufacturing, direct-to-consumer distribution and consumer self-application, Panther's MAPs are affordable, simultaneously enabling universal access and commercial success. Panther is led by accomplished tech, biotech and health professionals
The Opportunity
Panther Life Sciences is building a new category of consumer-centric health and beauty products powered by our dissolvable microarray patch (MAP) platform. As we move from development into commercialization, manufacturing becomes the critical unlock for scale, quality, and customer trust.
We are seeking a Director of Manufacturing Operations to own this transition end-to-end. This role is responsible for translating innovative R&D into reliable, high-quality, and scalable commercial production across both cosmetic and medical device products. You will lead the build-out of Panther's manufacturing strategy, serving as the bridge between internal development teams and external CDMO partners.
You will define how manufacturing operates at Panther, from selecting and standing up partners, to leading technology transfer, to building the systems that allow us to scale from thousands to millions of units. This is not a maintenance role. You will be building the manufacturing function from scratch. Your work will directly impact product availability, customer experience, and the company's ability to grow.
You will work closely with the CTO and cross-functional leaders in formulation, device development, and quality to establish a manufacturing engine that supports both near-term commercial goals and long-term platform expansion. This is for someone who wants to build, scale, and set the standard for manufacturing in a category-defining company with a great team and a platform that is already generating clinical results. If you want to build something that matters, we want to hear from you.
Some travel will required approximately 10% -30%
This role is based in New York City.
Responsibilities
CDMO & Manufacturing Operations
  • Serve as the primary relationship owner and day-to-day point of contact for CDMO partners
  • Lead technology transfer from R&D to clinical and commercial manufacturing
  • Oversee late-stage clinical and commercial production across product lines
  • Drive manufacturing performance metrics including yield, throughput, and product quality
  • Support CDMO selection and onboarding, including process validation and scale-up
  • Build and manage supply chain, logistics, fulfillment, and inventory operations
  • Own material sourcing and supplier relationships
  • Identify critical dependencies and build supplier redundancy to mitigate risk

Scaling, Systems & Financial Planning
  • Build the manufacturing line from the ground up with a path from ~10K to ~1M units per month
  • Drive automation, process optimization, and line redesign as production scales
  • Own manufacturing cost modeling and financial planning (FP&A) for operations
  • Develop sourcing strategy and budget frameworks in partnership with finance and leadership
  • Establish systems and processes to support future team growth and internal manufacturing capabilities

Quality, Compliance & Cross-Functional Leadership
  • Ensure manufacturing quality, regulatory compliance, and adherence to QMS
  • Partner cross-functionally with CTO, formulation, device, and quality teams
  • Contribute to customer satisfaction through reliable product delivery and issue resolution

Qualifications
  • Proven experience scaling a product from R&D to commercial manufacturing in a regulated environment
  • Experience overseeing manufacturing operations for a Class II or III medical device or equivalent regulated product
  • Hands-on experience scaling production volumes significantly (e.g., 10x or more)
  • Direct experience working with CDMO partners including selection, onboarding, and tech transfer
  • Experience managing supply chain, logistics, inventory, and fulfillment operations
  • Familiarity with Quality Management Systems (QMS) in regulated environments
  • Demonstrated ability to lead technology transfer and process scale-up
  • Experience with manufacturing cost modeling and financial planning
  • Direct people management experience

Preferred Qualifications
  • Experience with combination products (drug + device), such as auto-injectors, EpiPens, nasal sprays, or microarray-based systems
  • Background in Material Science & Technology Transfer (MSNT)
  • Experience scaling production to high-volume output (100K+ units per month)
  • Experience across both cosmetic and medical device products
  • Experience with automation and line redesign in a manufacturing scale-up context
  • Background in customer support or customer-facing operations within manufacturing
  • Experience managing managers or building multi-layered organizations
  • Strong systems orientation with experience implementing or optimizing operational infrastructure

Benefits
  • Equity in the form of Stock Options
  • Robust Health Insurance includes Medical, Dental, Vision
  • Life, AD&D, and Short-Term Disability Insurance
  • In-person company events
  • Fully-stock kitchen
  • In-office lunch twice a week
  • Working with a world-class team in technology and healthcare on the most innovative solutions
  • Paid time off and Paid Company Holidays.

Equal Opportunity Employer
Panther Life Sciences is an equal opportunity employer committed to building a diverse and inclusive workplace. We welcome applicants from all backgrounds and do not discriminate based on race, color, religion, gender, gender identity or expression, sexual orientation, pregnancy, marital or partnership status, age, national origin, citizenship, veteran or military status, disability, medical condition, genetic information, caregiver status, or any other characteristic protected by law.

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