Job Function: Discovery & Pre-Clinical/Clinical Development
Job Sub Function: Pharmaceutical Product R&D
Job Category:Scientific/Technology
All Job Posting Locations:Gurabo, Puerto Rico, United States of America
Job Description:We are searching for the best talent for an MSAT Senior Scientist to join our team in Gurabo, Puerto Rico.
The MSAT Senior Scientist is an experienced professional who applies scientific principles and industry knowledge to solve complex technical challenges. This role leads a diverse portfolio of assignments requiring strong judgment, problem-solving skills, and independent decision-making.
The Senior Scientist leads and delivers medium- to high-complexity projects and critical initiatives related to manufacturing, packaging, and cleaning validation. Responsibilities include conducting technical studies, leading investigations, and driving process improvement efforts. The incumbent maintains and applies expertise across key areas such as manufacturing operations, packaging processes, technology transfer, cleaning methodologies, and project management.
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 (consults other technical experts as needed). 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.
- Follows the Leadership Imperatives competencies based on their leadership level within the organization (Individual Leader).
QualificationsEducation:- Minimum of a Bachelor's degree required, focused degree in Biology, Microbiology, Chemistry, Engineering, or a related scientific field is preferred.
Experience and Skills:Required:- 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, with strong functional knowledge in applicable technical areas.
- 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.
- There is no direct supervisory responsibilities however demonstrates accountability for deliverables, proactively manages own workload, exercises sound judgment, and takes initiative to lead activities and resolve routine issues. May provide technical guidance or mentorship to junior scientists within project teams.
- Relevant education and training in one or more of the following areas: solid dosage form manufacturing and packaging; cleaning, process, and packaging validation; technology transfer; and regulatory compliance.
- 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
Required Skills: Preferred Skills:Coaching, Collaboration, Critical Thinking, Drug Discovery Development, Goal Attainment, Market Research, Organizing, Pharmaceutical Sciences, Pharmaceutical Trends, Product Development, Product Strategies, Report Writing, Research Documents, Research Proposals, Scientific Research, Standard Scientific Processes and Procedures, Technologically Savvy
