Job Description
Job Description
SUMMARY
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.
FUNCTIONS
-Conceives and designs, executes or evaluates, and interprets experimental strategies.
-Provides input to new processes to generate robust and reliable data.
-Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
-Designs, monitors or conducts experimental strategies with general guidance from supervisor.
-Provides data analysis and interpretation and assesses impact of the data on the project.
-Keeps current in field of scientific expertise and areas relevant to their function.
-Monitors field of expertise, including literature and technology development, and communicates relevant observations.
-May introduce advanced scientific methods.
-Develops and implements new and novel protocols to address specific issues.
-May represent the department on project teams under 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.
-Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
-Participates in external scientific community.
-May assume lead role in department-wide support efforts such as safety, recruiting and committees.
-May develop supervisory and mentoring skills.
-Develops and follows timelines for completing project teamwork.
EDUCATION
-Doctorate OR
-Master’s + 2 years of Scientific experience OR
-Bachelors + 4 years of Scientific experience.
COMPETENCIES/SKILLS
-Advanced scientific analysis and troubleshooting skills. Advanced laboratory work skills.
-Ability to motivate and/or supervise the activities of others.
-Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
-Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution. Analytical problem solving. Project management.
-Ability to be flexible and manage change.
-Computer literacy (Windows environment: Word, Excel, Power Point).
-Skills requiring the application of scientific theory.
-Creative skills in the design and performance of scientific experiments and interpretation of results.
-Strong knowledge of cGMP
-Fully bilingual (English/Spanish).
What attributes (i.e. - preferred qualifications) would make this candidate stand out?
• 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.