Senior Associate Scientist, Biologics I
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.
The Kansas City facility is a Center-of-Excellence for our Biologics Analytical Services business. Our talented team has over 25 years of experience providing analytical services for stand-alone and integrated biologics projects.
Position Summary
The main activities for the Senior Associate Scientist 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
In support of large molecule therapeutics, execute laboratory work plan / schedule developed with input from supervisor or senior team member. Sample types include in-process, release or stability. Techniques may include any or all of the following:
- Capillary and gel electrophoresis (e.g. CE-SDS, SDS-PAGE, icIEF, IEF, western blott, etc.)
- Mass spectrometry (e.g. LCMS, GCMS, ICP-MS, for small and large molecules)
- FTIR, NIR, Polarimetry (for small and large molecules as appropriate)
- Particle size testing
- Metals testing, ICP-OES, ICP-MS, AA (for small and large molecules)
- Compendial testing (e.g. viscosity, Osmolarity, osmolality, HIAC, etc.)
In support of large molecule therapeutics, under direction, may perform method validation or transfer activities.
- Perform activities under cGMP as appropriate.
- May draft technical documents such as methods or certificates of analysis.
- Performs parallel review of laboratory documentation and may become qualified to perform
- Technical review of documents for accuracy, thoroughness and regulatory compliance.
The Candidate
Education or Equivalent:
Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
Experience:
- Bachelor’s Degree: 3-5 years of relevant experience preferred or based on performance at Catalent.
- Master’s Degree: 0-2 years of relevant experience preferred or based on performance at Catalent.
Knowledge/Skills Requirements:
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs.
- Executes procedures or methods of moderate complexity with high quality.
- Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form.
- Basic understanding of instrument operations and troubleshooting skills in multiple techniques.
- Ability to identify aberrant/out of spec data and limited interpretation of data expected.
- Excellent written and verbal communications skills with internal and external customers.
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
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