Senior / Lead Upstream Manufacturing
BioPhase Solutions specializes in recruiting top talented professionals for Southern California's Scientific community. We are currently looking for a Senior/Lead Upstream Manufacturing to work for a San Diego Area contract manufacturing company.
Senior/Lead Upstream Manufacturing
Technical Skills and Knowledge requirements:
- cGMP experience
- Good aseptic techniques
- Mammalian / CHO cell culture, aseptic processing and bioreactor operation experience
- Participation in experimental design and execution of cell culture and protein purification studies; analyses of data generated from in-process samples, trends, and application of results to future experiments.
- Review and approve GMP documentation including batch records, specifications, qualification reports and protocols, specifically for cell culture, protein purifications, and support services.
- Design of Experiment (DoE) is required
- Anion Exchange Purification experience is preferred
- Diafiltration/Ultrafiltration experience is preferred
- Good data analysis skills
- Bachelors/Master’s degree in Life Sciences, Physical Sciences, Engineering, Pharmaceutical Sciences, or related scientific discipline is required. Masters degree is preferred.
- 5+ years of experience in the biotechnology, with focus in biologics drug substance manufacturing, development and Phase 3/large-scale commercial stage, cGMP manufacturing.
- Demonstrated experience with cell culture and bioreactor operations, chromatography and filtration methods, managing drug substance CMOs, transferring processes, process characterization and validation, and product comparability.
- Demonstrated interpersonal skills to work effectively with and/or manage internal stakeholders, and contractors, and cross-functional, cross-cultural project teams across multiple locations.
- Demonstrated experience in administering contracts, especially manufacturing or supply chain contracts.
- Knowledge of cGMP (FDA, EU and ICH) requirements, FDA/EU regulatory guidelines, validation practices, Quality, and Compliance principles.
- Ability to work independently in a dynamic and changing corporate environment.
- Working knowledge of risk management tools.
- Proficient computer skills, specifically with Microsoft Office Suite (Word, Excel, PowerPoint, and Outlook) and Microsoft Project.
- Excellent written and verbal communication skills required.
- Work with QA and Management to ensure product quality, costs, and schedule are clearly understood, well-documented, and consistently met.
If interested, please contact Sal Cisneros at (562)495-3200 x3 or send him a copy of your most updated resume at firstname.lastname@example.org. Please visit www.biophaseinc.com for additional jobs as well.