Senior Scientist

Key Responsibilities

• Responsible for the assessment of technical projects to develop strategy, plan and their execution.
• Coordinates project activities with site functional groups and other affiliates as required.
• May lead projects of medium/high complexity.
• Initiates change controls and completes technical/validation assessments to changes owned by other functional groups.
• Develops and/or reviews validation protocols in compliance with applicable standards and procedures.
• Coordinate project activities and resources for the execution as per project plan.
• Lead and actively participate in technology transfer activities to ensure successful and process implementation.
• Analyzes physical and analytical testing results from the study to summarize results and conclusions in technical reports.
• Evaluates problems/deviations resulting from validation exercises and recommends resolution.
• Works with other teams to address technical issues and resolve them using sound scientific reasoning and technical expertise.
• Determines along with team, corrective and preventive actions using the appropriate root cause analysis tools.
• Evaluates the effectiveness of the corrective actions.
• Identifying and reporting results that deviate from normal or expected results for routine and non-routine procedures and supports the resolution of the issue.
• Identifies areas of process improvements and works with technical groups in the implementation.
• May lead process improvements initiatives depending on complexity.
• Participates in regulatory audits and supports product/process requests from regulatory agencies.

Qualifications

Education: Minimum of a Bachelor's degree required, focused degree in Biology, Microbiology, Chemistry, Engineering, or a related scientific field is preferred.

Experience and Skills: Minimum of 6 years of relevant professional experience required; candidates with a Master's degree or PhD may qualify with 4-6 years of demonstrated experience in Technical Services, Validation, or related technical support roles within the pharmaceutical, biotechnology, or similarly regulated industries.

• Demonstrated ability to communicate effectively, collaborate cross-functionally, and build strong working relationships.
• Proficient in Microsoft Office applications; experience with project management software is preferred.
• Strong working knowledge of statistical tools and data analysis techniques.
• Solid technical and scientific foundation gained through a combination of education, training, certifications, and hands-on experience.
• Proficient in the use of controlled documentation systems, event management tools, and trending and tracking platforms.
• Working knowledge of current Good Manufacturing Practices (cGMPs), applicable regulations, and validation and technical support methodologies.
• Strong technical writing skills with the ability to clearly document processes, investigations, protocols, and reports.
• Experience with sampling, monitoring, and testing techniques in regulated manufacturing or laboratory environments.
• Demonstrated root cause analysis, troubleshooting, and diagnostic skills with the ability to apply scientific investigation methodologies.
• Strong project management skills, including working knowledge of FPx principles, tools, and methodologies.
• Willingness and ability to be cross-trained across multiple functional areas.
• Demonstrates leadership behaviors aligned with organizational Leadership Imperatives at the Individual Contributor level.

Preferred: Familiarity with manufacturing process sciences, technology transfer, Quality by Design (QbD), advanced analytical technologies, Process Analytical Technology (PAT), and continuous manufacturing is preferred.

Other: Bilingual proficiency in English and Spanish, with strong written and verbal communication skills. May provide technical guidance or mentorship to junior scientists within project teams. Ability to work a regular shift, with flexibility to support extended hours, weekends, and holidays as business needs require. Requires up to 10% domestic and/or international travel.