Position Summary:

　　Catalent Pharma Solutions is Morrisville, NC is hiring a Manager - Inhalation Quality Control to support the manufacturing quality control group supporting the Inhalation and Nasal business. The Manager, Inhalation & QC position will have oversight of quality control group (5+ direct reports) supporting in-process testing, release testing (raw materials, device components, and finished product), stability testing, and complaints testing for orally inhaled and nasal drug products manufactured from Morrisville and sister sites. This position will have responsibility for coordinating with supply chain for production planning and material readiness to support production.

　　This is a full-time role position: Monday – Friday, days. 8:00AM – 5:00PM

　　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

　　Operational and financial management responsibilities for inhalation manufacturing quality control function;

　　Support staffing, training, and development of QC personnel to achieve performance goals;

　　Achieve performance for key quality and compliance metrics

　　Develop, support and implement continuous improvement initiatives and new technologies to strengthen Catalent’s competitive position in the industry;

　　Establishing raw material and final products specifications. Overseeing raw material and final products testing and release according to approved procedures;

　　Collaborate with management peers to execute projects spanning the division, site or other Catalent sites;

　　Engage in organizational succession planning at the site;

　　Prepare for and contribute to budget planning for the site;

　　Ensure department work areas are maintained in a manner that is safe, clean, orderly, and complaint;

　　Demonstrable leadership experience at Catalent (including but not limited to participation in Catalent-sponsored leadership programs such as NGGL, GOLD, LEAD Now, GM Excellence, and GROW) may be considered in place of external experience;

　　All other duties as assigned;

　　The Candidate

　　Bachelor’s degree in a physical, chemical, biological, engineering, or pharmaceutical science required with 2+ years’ experience in a laboratory environment including experience with analytical equipment (e.g.: HPLC, UPLC, GC, MS, KF, FTIR);

　　Must have prior experience working in a regulated environment (e.g.: ISO, GMP).

　　2+ years’ experience with managing people highly preferred. Effective leadership skills including supervision, conflict resolution, situational leadership. Proven ability to lead, coach, and motivate employees.

　　Ability to support flexible schedule to accommodate workload, which may require off-shift work hours as job demands;

　　Experience with nasal and dry powder inhaler test method (e.g. APSD, DCU, Spray Pattern, Droplet Size Distribution) a plus;

　　Knowledge of verification, validation, and transfer requirements for methods used to support raw material testing and drug product testing;

　　Understanding of regulatory phase appropriate requirements supporting combination drug product submissions (eg. NDA, ANDA, 505b2)

　　Experience with different molecular modalities: small molecules, peptides, proteins, nucleic acids a plus

　　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

　　152 Hours 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 (https://careers.catalent.com/us/en) 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 (https://cdn.catalent.com/files/legal/CCPA-Privacy-Notice-at-Collection-for-California-Employees-and-Applicants-English.pdf) .