Senior Scientist, Forumlation

Position Summary:

Catalent Pharma Solutions is Morrisville, NC is hiring a Senior Scientist - Formulation for the Inhalation Product Development Group. This person will serve as the primary subject matter expert (SME) and client liaison related to formulation and product 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 formulation of nasal and inhalation products. Reviews progress and evaluates results. Plans and assigns personnel for given projects or tasks. Comply with divisional and site Environmental Health and Safety requirements.

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

• 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 intended to provide supporting pre-formulation, formulation, and manufacture lab/pilot scale prototype formulations for Phase I/II/III clinical development studies
• 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
• Represent Catalent and create expert content such as: posters, white papers, webinars & create relationships with academic collaborator
• 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
• BS with 6+ years of formulation experience for combination drug products; OR MS with 4+ years of relevant formulation experience; OR PhD with 2+ years of relevant formulation experience required
• Advanced project management skills are routinely practiced for multiple concurrent projects of moderate complexity
• Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPsIIn-depth knowledge of formulation development for drug-device combination products; preferably nasal and inhalation dosage forms involving poorly soluble, unstable, and impermeable drugs, controlled substances, and high potent compounds.
• Proven experience with leading pre-formulation studies such as saturation solubility, pH-solubility, pH-stability, drug-excipient and excipient-excipient compatibility evaluations
• Individual must have a working knowledge of pharmaceutical raw materials (i.e. excipients), and their application in pharmaceutical formulations for nasal and oral inhalation
• Knowledge with formulations properties including drug potency, toxicology, stability, pharmacokinetics, drug excipient interactions.
• Experience working with basic lab equipment such as osmometers, viscometers, density meters and ability to perform unit operations such as blending, solubilization, filling, and labelling and finishing.
• Experience with drug product performance evaluation testing such as droplet-size distribution, spray content uniformity, plume geometry, and spray pattern is preferred.
• 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.