Associate Scientist - Biologics II
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, execute laboratory work plan / schedule developed with input from supervisor or senior team member. Sample types include in-process, release or stability. Analytical 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
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
- Maintain high quality laboratory documentation in accordance with applicable regulatory guidance and Site SOPs
- Ability to learn and retain technical information
- Well organized with ability to multitask
- 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
- Mathematical and scientific reasoning ability
Education:
- Degree in life sciences such as chemistry, biochemistry, biology or closely related physical science.
- Bachelor’s Degree: 0-3 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
- 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
Business Environment:
- Fast-paced
- Performance Driven
- Customer Focused
- Collaborative and inclusive
- Professional Office Setting
- Confidential Department
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