Group Leader, Product Development

Reposted 3 Hours Ago
Be an Early Applicant
Morrisville, NC
In-Office
Junior
Biotech • Pharmaceutical
The Role
Lead a team developing formulations and analytical methods for nasal and inhalation early‑phase products, ensure data integrity and cGMP compliance, mentor staff, manage lab resources and timelines, and support feasibility and Phase I/II programs.
Summary Generated by Built In

Group Leader, Product Development

Position Summary:

  • Work Schedule: Monday - Friday, 8:00am to 5:00pm
  • 100% on-site

The Morrisville (MSV) facility is Catalent’s center of excellence for nasal product development and manufacturing, providing end‑to‑end services from early formulation through clinical and commercial production. The site offers comprehensive nasal development capabilities, including analytical support, device selection, spray characterization, and both clinical and commercial scale for unit‑dose, bi‑dose, and multidose nasal products. The Morrisville site also provides development services for dry powder (DPI) and liquid pulmonary products including formulation development and optimization, method services and analytical testing. 

The Group Leader oversees a team of scientists engaged in early-phase product development of nasal and orally inhaled drug products. This role ensures technical excellence in formulation, analytical characterization, and early phase process development for feasibility and Phase I/II programs, while maintaining compliance with cGMP and site safety standards. The Group Leader acts as a key technical and operational leader, driving innovation, capability building, and efficiency in early-stage development. 

The Role:

  • Lead development of formulations and processes for nasal sprays, dry powder inhalers, and nebulized products in early-phase programs 
  • Oversee analytical method development and execution (e.g., spray pattern, plume geometry, APSD, delivered dose) 
  • Ensure robust documentation and data integrity for feasibility and clinical batch support
  • Supervise and mentor scientists and technicians; set objectives, conduct performance reviews, and foster professional growth 
  • Manage lab scheduling, resource allocation, and workflow to meet project timelines
  • Other duties as assigned 

The Candidate:

  • Must have Ph. D in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 2 years of industry experience OR
  • Must have Master’s Degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 4-7 years of industry experience OR
  • Must have Bachelor’s Degree in Pharmaceutics, Chemistry, Chemical Engineering, or related field with 8-10+ years of industry experience
  • Experience with inhalation/nasal injectable product development is preferred
  • Deep technical expertise in formulation and analytical characterization of inhalation/nasal drug products (e.g., spray pattern, plume geometry, APSD, delivered dose) is preferred
  • Strong knowledge of cGMP, ICH guidelines, device standards, and early‑phase clinical development requirements is required
  • Demonstrated leadership skills, including mentoring, performance management, and fostering team development is required

Why you should join Catalent:

  • Defined career path and annual performance review and feedback process 
  • Diverse, inclusive culture 
  • Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives 
  • 152 hours of PTO + 8 paid holidays
  • Generous 401K match 
  • Medical, dental and vision benefits
  • Tuition Reimbursement - Let us help you finish your degree or start a new degree!

Catalent offers rewarding opportunities to further your career!  Join the global drug development and delivery leader and help us bring over 7,000 life-saving and life-enhancing products to patients around the world. Catalent is an exciting and growing international company where employees work directly with pharma, biopharma and consumer health companies of all sizes to advance new medicines from early development to clinical trials and to the market. Catalent produces more than 70 billion doses per year, and each one will be used by someone who is counting on us. Join us in making a difference. 

personal initiative. dynamic pace. meaningful work.

Visit Catalent Careers to explore career opportunities.

Catalent is an Equal Opportunity Employer, including disability and veterans.

If you require reasonable accommodation for any part of the application or hiring process due to a disability, you may submit your request by sending an email, and confirming your request for an accommodation and include the job number, title and location to [email protected]. This option is reserved for individuals who require accommodation due to a disability. Information received will be processed by a U.S. Catalent employee and then routed to a local recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.

    

Notice to Agency and Search Firm Representatives: Catalent Pharma Solutions (Catalent) is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Catalent employee by a third party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Catalent. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral. Thank you.

Important Security Notice to U.S. Job Seekers:

Catalent NEVER asks candidates to provide any type of payment, bank details, photocopies of identification, social security number or other highly sensitive personal information during the offer process, and we NEVER do so via email or social media. If you receive any such request, DO NOT respond— it is a fraudulent request. Please forward such requests to [email protected] for us to investigate with local authorities.

California Job Seekers can find our California Job Applicant Notice HERE.

Top Skills

Analytical Method Development
Apsd
Cgmp
Delivered Dose
Device Standards
Dry Powder Inhalers (Dpi)
Ich Guidelines
Nasal Sprays
Nebulizers
Plume Geometry
Spray Pattern
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The Company
HQ: Somerset, NJ
13,715 Employees
Year Founded: 2007

What We Do

Catalent, Inc. is a leading global contract development and manufacturing organization (CDMO) whose mission is to develop, manufacture, and supply products that help people live better and healthier lives. Catalent is dedicated to delivering unparalleled service to pharma, biotech, and consumer health customers, supporting product development, launch, and full life-cycle supply. With time-tested experience in development sciences, delivery technologies, and multi-modality manufacturing, Catalent supports the acceleration of development programs and the launch of more than a hundred new products every year. Powered by thousands of scientists and technicians and the latest technology platforms at more than 40 global sites, Catalent supplies billions of doses of life-enhancing and life-saving treatments for patients annually. For more information, visit www.catalent.com.

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