Group Leader, Product Development at CATALENT CTS SINGAPORE PRIVATE LIMITED

Durham, North Carolina, United States -

Full Time

Start Date

Immediate

Expiry Date

19 Jun, 26

Salary

0.0

Posted On

21 Mar, 26

Experience

10 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Product Development, Formulation Development, Analytical Characterization, Process Development, cGMP Compliance, Safety Standards, Team Leadership, Mentoring, Performance Reviews, Lab Scheduling, Resource Allocation, Nasal Sprays, Dry Powder Inhalers, Pulmonary Products, Spray Pattern, Plume Geometry

Industry

Pharmaceutical Manufacturing

Description

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 DisabilityAccommodations@catalent.com. 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 spam@catalent.com for us to investigate with local authorities. California Job Seekers can find our California Job Applicant Notice HERE.

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Responsibilities

The Group Leader oversees a team of scientists focusing on early-phase product development for nasal and orally inhaled drug products, ensuring technical excellence in formulation, analytical characterization, and early-phase process development while maintaining cGMP compliance. This role involves leading development activities for various inhalation products and supervising/mentoring the team, managing lab resources to meet project timelines.