Description:To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor.
Responsibilities: - Designs, monitors, or conducts strategies with general guidance from the supervisor.
- Provides data analysis and interpretation and assesses the impact of the data on the project. Keeps current in technical expertise and areas relevant to their function.
- Monitors field of expertise, including literature and technology development, and communicates relevant observations.
- Develop and implement new and novel protocols to address specific issues.
- May represent the department on project teams under the supervision of a senior scientific staff member.
- May initiate productive collaborations within and outside of the department or company.
- Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
- Able to develop solutions to routine technical problems of limited scope.
- Comprehensive understanding of validation protocol execution requirements. In-depth knowledge of validation processes as applied to new equipment installations.
Job Requirements:- Relevant experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling operations.
- Understanding of protein science, formulation and filling processes.
- Experience with process monitoring, data trending, and statistical analysis tools (e.g., JMP)
- Experience supporting deviations, investigations, root cause analysis, and product impact assessments.
- Ability to provide manufacturing floor support in a fast-paced, 24/7 operation.
- Bilingual proficiency in Spanish and English (written and verbal).
- Strong technical writing skills with experience preparing documentation for regulatory audits.
- Excellent communication, presentation, problem-solving, project management skills and cross-functional collaboration skills.
Education: - Doctorate OR Master's + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience
