- Job Title: Research Scientist I
- Company Name: B. Braun Medical Inc.
- Location: Irv
ine, California, USA 92623-9791
This position shall be part of the Quality Department and work cross functionally with various departments. The incumbent shall participate in idea generation, screening, and proof-of-concept activities for building a robust pharmaceutical product portfolio. This is a laboratory based position, and the incumbent shall be responsible for designing & executing experimental protocols for assessing the technical feasibility of the conceptualized product. The focus areas include Injectable drugs (generic & 505b2), Duplex® systems, Parenteral nutrition, and Product enabling formulation and drug delivery technologies (solubilized systems, lyophilization, drug-device combinations, etc.).
Responsibilities: Essential Duties
- Plans, organizes, and conducts experiments and research activities.
- Builds and tests new designs, formulations, materials, or systems for compliance with quality and/or performance standards
- Processes and analyzes results and data.
- Collaborates with Senior/Principal Scientists and/or management to apply the results of research and develop new techniques.
Expertise: Knowledge & Skills
- Requires full working knowledge of relevant business practices and procedures in professional field. Uses standard theories, principles, and concepts and integrates them to propose course of action.
- Knowledge of USP, EP, cGMP/GLP, FDA CFR & ICH regulations and guidelines.
- Working knowledge of chemical theories, concepts, test methods and instrumental methods.
- Analytical and research skills
- Strong communication (written and verbal), attention to detail and organizational skills
- Works under general supervision. Relies on experience and judgement to plan and accomplish assigned goals. May periodically assist in orienting, training, assigning & checking the work of other peers.
- Judgement is required in resolving complex problems based on experience.
- Contacts are primarily with direct supervisor, peers and subordinates.
- Analytical Methodologies and Validation Experience Preferred.