Job Description
Our client, a Biopharmaceutical company, is looking for a Associate Scientist, Purification Process Development for their Oceanside, CA location.
Responsibilities:
Requirements:
Why Should You Apply?
Responsibilities:
- The Associate Scientist, Purification Process Development (Pivotal and Commercial) will be responsible for leading and executing aspects of purification development including process development and process characterization at internal or external facilities for client biologics entities during pivotal and commercial development phases.
- Contribute to experimental design. Plan and execute assigned purification process development laboratory studies. Support process scaleup and implementation in internal and external GMP facilities.
- Collect and analyze data from laboratory experiments in compliance with data integrity policy. Author experimental protocols and reports.
- Support process transfer to internal and contract manufacturing facilities to produce GMP and non GMP drug substances on time and with high success rate.
- Provide technical support for manufacturing atypical event investigations.
- Ensure high-quality documentation in electronic laboratory notebooks, protocols, and reports.
- Mentor junior team members on purification process development strategies, experimental design, and execution as well as process transfer.
- Help to establish and maintain a state-of-the-art purification lab.
- Execute purification platform development and new technology/innovation evaluation and implementation to enable pivotal clinical trials.
- Participate in cross functional initiatives as needed.
- Adhere to department budget and all training, compliance and safety requirements.
Requirements:
- M.S. with 2+ years or BS with 4+ years’ experience in a relevant scientific discipline (chemical engineering, biochemistry, bioengineering).
- Hands-on laboratory operations experience with purification process operations including centrifugation, normal flow filtration, high throughput purification screening and development, chromatography operations, tangential flow filtration, and virus inactivation/removal is required.
- Experience with AKTA chromatography systems and UNICORN software is preferred
- Experience in pivotal stage purification process development, characterization, and implementation in GMP facilities.
- Working knowledge of lab automation, data management, data science, knowledge management and data protection.
- Demonstrated ability to collaborate and influence cross-functionally.
- Experience in statistics, design-of-experiments, and data analysis (e.g. JMP, Spotfire).
- Motivated self-starter with excellent interpersonal and organizational skills.
- Excellent verbal communication, oral presentation, and scientific writing skills.
Why Should You Apply?
- Health Benefits
- Referral Program
- Excellent growth and advancement opportunities
Numbers & Facts
| Location | Oceanside, CA |
| Industry | Management Consulting Services |
| Salary | $40.27–$45.27 Per Hour |
| Company Size | 2,000 to 2,499 employees |
| Year Founded | 2000 |
| Website | https://www.iconma.com/ |
Benefits
401K, Employee Referral Program, Life Insurance
About Company
ICONMA is a global information consulting management firm providing Professional Staffing Services and Project-Based Solutions for organizations in a broad range of industries.
- Corporate Headquarters in Troy, Michigan; 20+ locations worldwide.
- Certified Woman-Owned Business Enterprise (WBE); certified by Women’s Business Enterprise National Council, National Women Business Owners Corporation (NWBOC); and California Public Utilities Commission (CPUC).
- Founded in 2000
- 2000+ Employees
The company was founded on the principle that success is derived from delivering high quality service and resources in the most responsive, flexible, and innovative way. ICONMA invests in people and resources with a single goal: To provide our customers with the highest quality service in the most responsive manner. Through its network of offices, ICONMA provides the resources to help clients maintain their competitive advantage.
Skills
- Biochemistryunmatched
- Bioengineeringunmatched
- Budgetingunmatched
- Chemical Engineeringunmatched
- Chromatographic Systemsunmatched
- Chromatographyunmatched
- Clinical Trialunmatched
- Contract Manufacturingunmatched
- Cross-Functionalunmatched
- Data Analysisunmatched
- Data Collectionunmatched
- Data Managementunmatched
- Data Qualityunmatched
- Data Scienceunmatched
- Documentationunmatched
- Experiment Designunmatched
- GMP (Good Manufacturing Practices)unmatched
- Health Planunmatched
- High Throughputunmatched
- Information/Data Security (InfoSec)unmatched
- Interpersonal Skillsunmatched
- Knowledge Managementunmatched
- Laboratoryunmatched
- Laboratory Analysisunmatched
- Laboratory Automationunmatched
- Laboratory Notebookunmatched
- Laboratory Operationsunmatched
- Manufacturingunmatched
- Mentoringunmatched
- Operations Processesunmatched
- Organizational Skillsunmatched
- Pivotal CRMunmatched
- Presentation/Verbal Skillsunmatched
- Process Developmentunmatched
- Regulatory Complianceunmatched
- Safety Trainingunmatched
- Statisticsunmatched
- Strategic Planningunmatched
- Team Playerunmatched
- Technical Supportunmatched
- Time Managementunmatched
- Unicorn Library Management Systemunmatched
- Virusesunmatched
- Writing Skillsunmatched
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