Group Leader, Product Development

Position Summary:

Catalent Pharma Solutions is Morrisville, NC is hiring a Group Leader, Product Development. This person will serve as the primary subject matter expert (SME) and client liaison related to product development activities supporting nasal and inhalation development programs. This person will also have supervisory responsibility for a team of 6-8 laboratory personnel. Plans, conducts and supervises assignments involving the analytical testing for nasal and inhalation products from early phase programs to late phase programs. Reviews progress and evaluates results. Plans and assigns personnel for given projects or tasks.

This is a full-time role position: Monday - Friday, days.

Catalent is a global, high-growth, public company and a leading partner for the pharmaceutical industry in the development and manufacturing of new treatments for patients worldwide. Your talents, ideas, and passion are essential to our mission: to help people live better, healthier lives.

The Research Triangle Park (RTP) facility is Catalent's Center of Excellence for Analytical Services and is also home to Catalent's Inhalation franchise including product development, clinical and commercial manufacturing for pMDI, DPI and Nasal Sprays.

Catalent is committed to a Patient First culture through excellence in quality and compliance, and to the safety of every patient, consumer, and Catalent employee.

The Role

• Responsible as technical development lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business.
• To supervise and coordinate activities of a team of Scientists, Senior Scientists and/or Associates within the product development group.
• To oversee projects and maintain project timelines and budget
• To ensure that safe working practices are adopted in the laboratory and to comply with in-house SOPs and other safety legislation.
• To communicate effectively with both internal and external customers, peers and supervising managers to facilitate the smooth conduct of project activities.
• Represent Catalent and create expert content such as: posters, white papers, webinars & create relationships with academic collaborator
• To ensure that appraisals and performance reviews are carried out in accordance with company policy. Identify training needs of subordinates through discussion and with reference to the core competencies.
• To assure the integrity and quality of analytical data produced by ensuring staff are adhering to all relevant in-house and client SOPs and methodologies and following the requirements of GMP.
• To perform checking & verifying of peers' analytical data in accordance with in-house SOPs.
• Perform testing and technical peer review, as necessary.
• All other duties as assigned;

The Candidate

• Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
• Bachelor's Degree with 12+ years of relevant experience preferred; OR Master's degree: 10+ years of relevant experience preferred; OR Doctorate Degree: 8+ years of relevant experience preferred or based on performance at Catalent.
• Advanced project management skills are routinely practiced for multiple concurrent projects of moderate to high complexity
• Experienced in most aspects of drug development and lifecycle support for inhalation drug products, and able to develop useful strategies and tactics to meet regulatory milestones.
• Experienced and well versed in Method Validation requirements for Early phase and late phase products per ICH guidelines.
• Has substantial breadth/depth of technical acumen in multiple analytical techniques with significant expertise in method development for HPLC assay, impurities and performance testing ie APSD and Delivered Dose.
• Experience with drug product performance evaluation testing such as droplet-size distribution, spray content uniformity, plume geometry, and spray pattern is preferred.
• Capable of rapidly learning multiple unfamiliar principles or techniques with minimum training
• Well organized with ability to handle and direct multiple activities simultaneously
• Individual may be required to sit, stand, walk regularly and occasionally lift 0-15 pounds;

Why you should join Catalent:

• Defined career path and annual performance review and feedback process
• Diverse, inclusive culture
• 19 days of PTO + 8 paid holidays
• Several Employee Resource Groups focusing on D&I
• Dynamic, fast-paced work environment
• Employee Stock Purchase Program
• Positive working environment focusing on continually improving processes to remain innovative
• Potential for career growth on an expanding team within an organization dedicated to preserving and bettering lives
• Competitive salary with bonus potential
• Community engagement and green initiatives
• Generous 401K match and Paid Time Off accrual
• Medical, dental and vision benefits effective day one of employment
• Tuition Reimbursement - Let us help you finish your degree or earn a new one!
• GymPass program to promote overall physical wellness
• Perkspot - offers exclusive or private discounts from approximately 900+ merchants in a wide array of categories

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.

Catalent is committed to the health and safety of its employees, visitors and the customers and patients we serve. As a result of the global pandemic, we have modified many of our recruitment and on-boarding processes to maintain everyone's safety. The Human Resources teams will communicate all necessary safety processes and procedures throughout each stage.

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.