Senior Scientist

Johnson & Johnson Innovative Medicine • Gurabo, PR

20h • Onsite

About The Position

Johnson & Johnson Innovative Medicine is seeking a Senior Scientist to join its team in Gurabo, Puerto Rico. The Senior Scientist applies scientific principles and industry knowledge to solve complex technical challenges and independently leads a diverse portfolio of assignments. The role delivers medium- to high-complexity projects and critical initiatives involving manufacturing, packaging, and cleaning validation, including technical studies, investigations, and process improvements. The position maintains and applies expertise in manufacturing operations, packaging processes, technology transfer, cleaning methodologies, and project management.

The Senior Scientist assesses technical projects, develops strategies and plans, coordinates execution with site functions and affiliates, and may lead projects of medium or high complexity. The role initiates change controls, prepares or reviews validation protocols and technical assessments, and coordinates project resources. It also supports technology transfers, analyzes study results, writes technical reports, evaluates validation deviations, and recommends resolutions. The scientist collaborates with technical teams to investigate and resolve issues, determine and evaluate corrective and preventive actions, identify process improvements, and support regulatory audits and agency requests. There are no direct supervisory responsibilities, though the role may provide technical guidance or mentorship to junior scientists. The position requires a regular shift, with flexibility for extended hours, weekends, and holidays as business needs require, and up to 10% domestic and/or international travel.

Requirements

• Bachelor's degree required; a focus in Biology, Microbiology, Chemistry, Engineering, or a related scientific field is preferred.
• At least 6 years of relevant professional experience; 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 in pharmaceutical, biotechnology, or similarly regulated industries.
• Ability to communicate effectively, collaborate cross-functionally, and build strong working relationships.
• Proficiency with Microsoft Office applications.
• Strong working knowledge of statistical tools and data analysis techniques.
• Solid technical and scientific foundation from education, training, certifications, and hands-on experience, with functional knowledge in applicable technical areas.
• Proficiency with 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, including the ability to clearly document processes, investigations, protocols, and reports.
• Experience with sampling, monitoring, and testing techniques in regulated manufacturing or laboratory environments.
• Root-cause analysis, troubleshooting, and diagnostic skills, including 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.
• Leadership behaviors aligned with organizational Leadership Imperatives at the Individual Contributor level.
• Bilingual proficiency in English and Spanish, with strong written and verbal communication skills.
• Ability to work a regular shift and flexibility to support extended hours, weekends, and holidays as business needs require.
• Ability to travel up to 10% domestically and/or internationally.
• Relevant education and training in one or more of the following: solid dosage form manufacturing and packaging; cleaning, process, and packaging validation; technology transfer; or regulatory compliance.

Nice To Haves

• Focused degree in Biology, Microbiology, Chemistry, Engineering, or a related scientific field.
• Experience with project management software.
• Familiarity with manufacturing process sciences, technology transfer, Quality by Design (QbD), advanced analytical technologies, Process Analytical Technology (PAT), and continuous manufacturing.

Responsibilities

• Assess technical projects and develop strategies, plans, and execution approaches; coordinate project activities with site functional groups and affiliates, and lead projects of medium or high complexity as appropriate.
• Initiate change controls and complete technical and validation assessments for changes owned by other functional groups.
• Develop and/or review validation protocols in compliance with applicable standards and procedures.
• Coordinate project activities and resources to execute work according to project plans.
• Lead and actively participate in technology transfer activities to support successful process implementation.
• Analyze physical and analytical testing results, summarize findings and conclusions in technical reports, evaluate problems or deviations arising from validation exercises, and recommend resolutions.
• Collaborate with teams and technical experts to address technical issues using scientific reasoning and expertise.
• Determine corrective and preventive actions with the team using appropriate root-cause analysis tools, and evaluate their effectiveness.
• Identify and report results that deviate from normal or expected outcomes in routine and non-routine procedures, and support issue resolution.
• Identify process improvement opportunities and work with technical groups to implement them; lead initiatives depending on complexity.
• Participate in regulatory audits and support product or process requests from regulatory agencies.
• Follow Leadership Imperatives competencies applicable to the Individual Leader level.
• Manage personal workload and deliverables, exercise sound judgment, take initiative to lead activities and resolve routine issues, and provide technical guidance or mentorship to junior scientists when appropriate.
• Support a regular shift and, as business needs require, extended hours, weekends, and holidays; travel up to 10% domestically and/or internationally.

What This Job Offers

• Job Type: Full-time
• Career Level: Senior