Sr. Engineer I – Global Biologics DP MSAT – Scientist
| Company | Gilead Sciences |
|---|---|
| Location | San Mateo, CA, USA |
| Salary | $146540 – $189640 |
| Type | Full-Time |
| Degrees | Bachelor’s, Master’s, PhD |
| Experience Level | Mid Level, Senior |
Requirements
- Degree in Chemical Engineering, Bioengineering, pharmaceutical sciences or related field, and appropriate years of experience:
- Ph.D. with minimal work experience OR
- MS with 4+ years of relevant work experience OR
- BS with 6+ years of relevant work experience
Responsibilities
- Represent Global Biologics MSAT group on project teams as a subject matter expert for sterile fill/finish activities including process transfer and validation.
- Contribute to project workstreams such as facility fit, risk assessments, control strategy development, validation strategy, change management. Author reports associated with these activities.
- Follow GMP change management procedures to ensure timely and successful implementation of new processes and subsequent changes. Partner with process development, quality, and regulatory affairs during investigations to address OOS, OOT, and complex deviations.
- Collaborate with process development group to support process characterization activities and establishment of design space to enable commercial tech transfer and validation. Participate in internal development teams as MSAT representative.
- Review technical documentation including protocols, master batch records, and reports for engineering runs, GMP and PPQ campaigns.
- Contribute to process validation sections of regulatory filings in support of commercial launch/expansion.
- Participate in cross functional business and scientific initiatives as MSAT representative, and effectively collaborate and influence cross-functional partners to support team objectives.
- Up to 20% travel in support of the above activities
Preferred Qualifications
- Strong understanding of biologics/sterile injectable product manufacturing processes e.g., bulk freeze/thaw, mixing/pooling, filtration, filling and/or lyophilization
- Experience supporting drug product manufacturing operations, technology transfer, and/or development. Past history with commercial manufacturing and/or process validation is highly desirable.
- Working knowledge of GMPs and regulatory requirements of biopharmaceutical manufacturing
- Excellent troubleshooting skills and ability to solve complex technical issues.
- General understanding of protein structure and modes of degradation under various processing conditions
- Ability to effectively collaborate in a dynamic, cross-functional matrix environment.
- Excellent and effective verbal and written communication skills
- Experience working in agile global and multi-cultural teams