Senior Scientist, Product Development

Position Summary:
Catalent Pharma Solutions is Morrisville, NC is hiring a Senior Scientist, Product Development for the Inhalation Product Development Group. The Morrisville (MSV) facility is Catalent's Center of Excellence for Nasal Product Development, Analytical Services, and Early Phase Development of Dry Powders for oral inhalation.
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 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

• This person will serve as the primary subject matter expert (SME) and client liaison related to device related development activities supporting nasal and inhalation development programs.
• Plans, conducts and supervises assignments involving the identification, assessment and development of new scientific concepts and technologies relating to supporting the characterization and functional assessment of nasal and inhalation products.
• Reviews progress and evaluates results. Plans and assigns personnel for projects or tasks. Recommends changes in procedures. Operates with substantial latitude for unreviewed action or decision. Reviews progress with management. Comply with divisional and site Environmental Health and Safety requirements.
• Review technical documents for accuracy, thoroughness and regulatory compliance
• Responsible as technical development lead on multiple projects, with responsibility for project outcome and customer interaction, including developing customer relationship to grow the business.
• Design experimental studies, such as feasibility & reliability assessments, to evaluate device performance and function for early and late phase programs.
• Lead and mentor multi-disciplinary project team of internal scientists and engineers to meet technical milestones on appropriate timelines and provide technical feedback and recommendations at the project level
• Provide technical support to Operations by establishing the requirements for batch manufacturing and overseeing the execution of any required studies as well as leading risk assessments.
• Represent Catalent and create expert content such as: posters, white papers, webinars & create relationships with academic collaborators
• Identify and support introduction of new technologies to enhance product development capabilities at the site.
• All other duties as assigned;
  

The Candidate

• 4-year degree in a physical, chemical, biological, engineering, or pharmaceutical science required
• Bachelors with 6+ years of formulation experience for combination drug products; OR Masters with 4+ years of formulation experience for combination drug products; OR PhD with 2+ years of formulation experience for combination drug products
• Experience with drug-device combination products required; preference for knowledge of devices used for nasal delivery and oral inhalation and how their design and function support performance requirements
• Experience conducting risk assessments using FMEA and FTA.
• Expertise with drug-device product evaluation such as droplet-size distribution, spray content uniformity, plume geometry, and spray pattern is preferred.
• Hands on experience and knowledge with Design of Experiments (DoE) and experience statistical software packages (e.g. Minitab).
• Experience working in a GMP environment.
• Experience with different molecular modalities: small molecules, peptides, proteins, nucleic acids (pharmaceutics and pharmacokinetics) a plus
• Experienced in most aspects of drug development and lifecycle support, and able to develop useful strategies and tactics to meet regulatory milestones. Ability to provide reliable/defendable interpretations of regulatory guidance for the customer
• 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 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.