Catalent Pharma Solutions Senior Scientist Formulation and Drug Product Development in Gaithersburg, Maryland
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 (http://www.catalent.com/index.php/about-us/Catalent-Careers2)
Catalent Gene Therapy is looking to recruit a Senior Scientist-Drug Product Development to join our growing team in Gaithersburg, MD.
Expertise in development of robust formulations for macromolecules (proteins, peptides, vectors for gene therapy);
Design and execute formulation development activities (including liquid/lyophilized/spray dried formulations);
Advance lyophilization program within the formulation and drug product group to include, lyophilized formulations and lyophilization process development studies;
Design and establish drug product process development (fill-finish) activities in collaboration with drug product manufacturing group;
Supervise and coordinate the activities of junior level team members;
Participate in project team meetings as a member or as a leader of a team to support client projects and deadlines;
Assists with development of scope of work in response to requests for proposals from prospective clients;
Remain up-to-date with lyophilization and similar technologies for current and future product development;
PhD in Pharmaceutics, Chemistry, or equivalent with 5-7 years of experience OR Master’s degree in any of the aforementioned disciplines with 7-10 years of experience in biologics, vaccines, biotech, pharmaceutical R&D environment – pertaining to formulation/drug product development;
Knowledge and expertise in formulation development, lyophilization development, and development of spray drying of macro-molecules;
Knowledge and expertise in development and characterization of nanoparticle technologies
Knowledge and expertise in principles and practice of current Good Manufacturing Practices (cGMP) and Good Laboratory Practices (GLP) and in FDA / CBER regulations regarding the manufacturing of biological and/or vaccines;
Working knowledge of DOE software i.e. JMP;
Experience in handling sterile dosage forms and aseptic preparation techniques and in aseptic development of late stage clinical products and/or commercial products
Catalent’s Standard Leadership Competencies
Leads with Integrity and Respect
Demonstrates Business Acumen
Fosters Collaboration and Teamwork
Engages and Inspires
Coaches and Develops
Potential for career growth within an expanding team
Defined career path and annual performance review & feedback process
Cross functional exposure to other areas of within the organization
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 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 (https://catalent.wd1.myworkdayjobs.com/External) 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 (https://www.youtube.com/playlist?list=PLuUGqEwwnH7hBwFlrsfSOH_raQHu4hOBK) .