Catalent Pharma Solutions Lead Scientist - Large Molecule in Morrisville, North Carolina
Catalent hires people with a passion to make a difference to the health of millions of people globally. Your expertise, coupled with Catalent’s advanced technologies and collaboration with thousands of innovative pharmaceutical, biotech and healthcare companies, will help bring life-enhancing products to the people you know and love. Your talents, ideas and passion are essential to our mission; to develop, manufacture and supply products that help people live better, healthier lives. Interested in learning more about life at Catalent? Start here
This position will report directly to the Principal Scientist
Catalent is looking to recruit an experienced Pharmaceutical Scientist to join a growing scientific group at our site in Morrisville, NC. This laboratory group is responsible for the support of large molecule drug product development both directly with customers and in collaboration with other Catalent facilities. The Lead Scientist works with minimum supervision and may get assisted by laboratory technicians/associates. He/she demonstrates potential for technical proficiency and scientific creativity through broad assignments. He/she may be responsible for setting and defining technical objectives and assessing results. Comply with divisional and site Environmental Health and Safety requirements.
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.
Design experiments to elucidate the physicochemical properties of large molecule drug product candidates using UPLC-MS/MS.
Author SOP’s, protocols, certificates of analysis and technical reports to summarize results of these experiments.
Supervision of lower level scientists.
Lead technical discussions to define scope of work and to provide data to drive next experiments.
Required education and experience are as follows: A PhD with 4-7 years related experience OR a Master’s degree with 7-10 years related experience OR a Bachelor’s degree with 10+ years of related experience. The candidate’s degree should be in Chemistry, Pharmaceutical Sciences, Biochemistry, Biology, Chemical/Biochemical Engineering, or related field
Extensive experience analyzing biologics (glycoproteins and nucleotides) via MSMS, intact mass analysis, peptide mapping, disulfide bond mapping, and/or N-glycan profiling is required.
Previous experience using Waters QTOF instruments and MassLynx or UNIFI software to produce and analyze UPLC-MS/MS data is required.
Previous experience using Agilent Q instruments and Chemstation or Openlab software to produce and analyze HPLC-MS data is required.
Extensive knowledge on method development and phase-appropriate method validation is required.
The candidate must have a proven track record in designing and executing experimental plans and have demonstrated experience writing reports, SOPs, and project protocols.
Previous experience supervising diverse scientific teams is required.
Knowledge of cGMP/cGLP regulations and ICH quality guidelines is preferred.
Medical, Dental, Vision and 401K are all offered from day one of employment
19 days of paid time off annually + 7 paid holidays
Leadership Competencies for Performance and Development
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
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 www.catalent.com/careers to explore career opportunities.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, protected veteran status, sexual orientation or gender identity. 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.
Catalent = Catalyst + Talent
Your talents, ideas, and passion are essential to our mission: to develop, manufacture, and supply products that help people live better, healthier lives. Join us!
personal initiative. dynamic pace. meaningful work.
Catalent is the perfect place to grow your career if…
You enjoy the fast pace of a start-up, but want the opportunities and stability of a growing, publicly traded company (Listed on NYSE: CTLT).
You want meaningful work. From cough treatments to cancer-fighting drugs, biologics, and vitamins, we help develop, launch, and supply over 200 new products each year – more than any branded drug maker in the world!
You want to plant your career in a growing company. Over the last five years, Catalent has re-invested more than $2 billion back into the company and its people.
You are excited about learning, collaborating, and growing alongside a global diverse team. Our team of more than 11,000 comes to work every day ready to overcome new challenges with teamwork, advanced technologies, and a passion to deliver by putting patients first.
You want to make a global impact! From North America to Europe, Asia to Latin America, we have innovative science and manufacturing teams who are looking for YOU!
See how our teams are making a difference, while growing their careers and fulfilling our mission by putting patients first every day here.
Catalent is an Equal Opportunity / Affirmative Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability, or protected veteran status. 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 along with the job number and title to Jobs@catalent.com. This option is reserved for individuals who require accommodation due to a disability. Information received will be routed to a recruiter who will provide assistance to ensure appropriate consideration in the application or hiring process.