Lead Scientist, Analytics - Mass Spectrometry
Catalent’s Kansas City facility is home to our Oral & Specialty Drug Delivery, Biologics Analytical Services and Clinical Supply Services businesses. The site provides a range of integrated services for oral solid dosage forms, from formulation development and analytical testing to clinical and commercial-scale manufacture.
Position Summary
Our Oral & Specialty Drug Delivery business continues to grow, and we are adding to our Small Molecule Analytical Chemistry team. Working with a new Waters Xevo TQ-XS Tandem Quad, the Lead Scientist, Analytics - Mass Spectrometry will help install, qualified, and use expertise with method development and method transfer. In addition, the Lead Scientist, Analytics - Mass Spectrometry will provide and report data, as required by project contracts within the Analytics 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:
In support of small molecule therapeutics, develop and execute laboratory work, plans/schedules independently using customer milestones and Division/site performance standards and metrics.
Sample types include in-process, release or stability for CMC support. Techniques may include any or all of the following:
- Mass spectrometry (LCMS, GCMS, ICP-MS, for small molecules)
- HPLC
In addition:
- Perform method validation or transfer activities, as needed. Under direction, perform method development activities
- Perform various types of testing under cGMP, as appropriate.
- Author technical documents, such as protocols, test methods, reports, certificates of analysis, and operating procedures
- Review technical documents for accuracy, thoroughness and regulatory compliance
- Train, coach or mentor others on technical, personal development or business issues
The Candidate:
Education:
- Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science. Bachelor’s Degree: 9+ years of relevant experience OR Master’s Degree: 6+ years of relevant experience OR Doctorate Degree: 2+ years of relevant experience
Experience:
Knowledge/Skills Requirements:
- Experience with Mass Spectrometry with exposure to method development
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and site SOPs
- Proactively address work issues at both an individual level and a team level
- Develop and execute complex procedures or methods with high quality
- Recognizes and elevates changes in project scope or execution for review by project director
- Propose deviations from established procedures and methods based upon sound judgment.
Physical Requirements:
- On an average 8 hour day this position requires the ability to walk, sit and stand, reach with hands and arms at or above shoulder height and below waist height, climb or balance, stoop, kneel, crouch, or crawl; talk and hear, and smell.
- Specific vision requirements including reading of written documents, visual inspection of materials and use of computer monitor screen frequently
- May require the use of a respirator
Catalent’s standard leadership competencies:
- Leads with Integrity and Respect
- Delivers Results
- Demonstrates Business Acumen
- Fosters Collaboration and Teamwork
- Champions Change
- Engages and Inspires
- Coaches and Develops
Why you should join Catalent:
- 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