Scientist
Position Summary
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
In support of large 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:
- Mammalian cell culture
- Sterile technique
- In vitro cell based assays (e.g. reporter gene bioassay, cell titer glo proliferation bioassay, etc.)
- ELISA assays, quantitative and potency (fluorescence, luminescence, colorimetric, MSD)
- Molecular biology (e.g. qPCR, PCR, etc.)
- Kinetic binding assessment (e.g. BLI or SPR)
- Flow cytometry
- Other technologies/methodologies as required by management
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
- Execute efficiency improvement project with guidance
The Candidate
- Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
Experience:
- Bachelors Degree: 7-9 years of relevant experience preferred or based on performance at Catalent.
- Masters Degree: 2-4 years of relevant experience preferred or based on performance at Catalent.
- Doctorate 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
- Ability to learn and retain technical information
- Proactively address work issues at both an individual level and a team level
- Develop and execute complex procedures or methods with high quality
- Becoming familiar with drug development milestones and their context
- Recognizes and elevates changes in project scope or execution for review by project director
- Able to prioritize and suggest alternatives or contingencies to achieve the correct technical solutions with most efficient resource utilization
- Propose deviations from established procedures and methods based upon sound judgment.
- Can organize and manage teams chartered to address resolution of lab issues or special projects with general management guidance.
- Can assess training needs and formulate development plans for subordinates
- Can effectively back-up supervisor to address limited technical or business issues with prior instructions
- Well organized with ability to multitask
- Ability to work effectively under pressure to meet deadlines
Catalent’s 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