Senior Scientist, Biologics
Kansas City, Missouri, United States
Job type: fulltime
Job industry: Science & Technology
Job Description Job Title Senior Scientist, Biologics II Position Summary (Biologics, Kansas City, MO) The Sr. Scientist will report to Group Leader, Pharmaceutical Development The main activities will be to provide and report data, as required by project contracts within the Biologics Department. The data may be used for submission in Regulatory packages, release and stability testing of clinical and animal trial dose forms and in support of development projects. The Role (daily responsibilities) In support of large molecule therapeutics, develop and execute laboratory work plans/schedules for self and junior members of team, using customer milestones and Division/site performance standards and metrics. Sample types include in-process, release or stability. Techniques may include any or all of the following: HPLC/UPLC techniques/methods (e.g. SEC, IEX, RP-HPLC, HIC, peptide map, glycan analysis, etc.) Karl Fischer, Compendia assays, (i.e. appearance. pH, etc.) UV-Vis, Solo-VPE, Nano Drop Aggregation techniques such as MFI, AUC, SEC-MALS Other technologies/methodologies as required by management In support of large molecule therapeutics, perform and/or guide method validation or transfer activities. Perform and/or guide method development activities Perform activities under cGMP as appropriate. Independently authors and approves technical documents, such as protocols, test methods, text reports, certificates of analysis, and operating procedures. Review technical documents for accuracy, thoroughness and regulatory compliance Trains, coaches or mentors others on technical, personal development or business issues Supervises technical staff, including work assignments and performance and development management The Candidate (requirements) Bachelors Degree: >10 years of relevant experience preferred or based on performance at Catalent. Masters Degree: >8 years of relevant experience preferred or based on performance at Catalent. Doctorate Degree: >4 years of relevant experience preferred or based on performance at Catalent. Leads with Integrity and Respect Delivers Results Demonstrates Business Acumen Fosters Collaboration and Teamwork Champions Change Engages and Inspires Coaches and Develops Position Benefits Medical, Dental, Vision and 401K are all offered from day one of employment 19 days of paid time off annually Potential for career growth within an expanding team Defined career path and annual performance review and feedback process About Catalent 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. More products. Better treatments. Reliably supplied. ™ Visit 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 along with the job number and title to Jobscatalent.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. 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.