Title: Process Development Senior Scientist – Job ID 35535 & 35534

Location: Juncos, Puerto Rico

Important Notice: This opportunity is available only for direct individual candidates. Third-party contractor submissions, staffing vendors, and Corp-to-Corp (C2C) arrangements will not be considered for this position.

Work Schedule: On-site | Administrative Shift

(Availability to work different shifts and/or weekends as business needs require)

Contract Duration: 5 months

Position Summary

Our client is seeking an experienced Process Development Senior Scientist to independently conceive, design, execute, and advance scientific experiments and process development initiatives that support strategic projects and organizational goals within a highly regulated manufacturing environment.

The successful candidate will serve as a scientific and technical leader, providing innovative solutions, advancing new technologies, generating robust and reliable data, and supporting process improvements from concept through execution. This role requires strong analytical capabilities, technical expertise, project management skills, and the ability to independently manage complex scientific studies while collaborating with cross-functional teams.

The Senior Scientist will function as a lead scientific/technical resource or project leader, supporting process development, process characterization, validation activities, commercial process support, and continuous improvement initiatives within a GMP-regulated pharmaceutical or biotechnology environment.

Key Responsibilities

• Independently design, monitor, execute, and interpret scientific experiments, studies, and research programs to support project objectives, process improvements, and technology advancement.
• Develop innovative experimental designs, scientific strategies, protocols, and methodologies to generate meaningful and reliable data.
• Analyze and interpret complex scientific data, evaluate project impact, identify trends, and provide technically sound recommendations to support business and manufacturing objectives.
• Develop scientific analyses and technical solutions using sound scientific principles and engineering concepts.
• Support process development activities including process characterization, process validation (PPQ), technology transfer, and commercial manufacturing support.
• Apply scientific expertise to evaluate process performance, identify improvement opportunities, and recommend solutions to optimize manufacturing processes.
• Research and evaluate external technologies, industry trends, competitive scientific developments, and emerging methodologies relevant to assigned projects.
• Expand technical knowledge beyond core areas of expertise and apply new scientific concepts to advance projects and technologies.
• Introduce and implement advanced technologies, methodologies, and scientific approaches to improve process robustness and reliability.
• Serve as a key contributor or technical lead for multidisciplinary research and development projects.
• Establish productive collaborations across departments and with external partners when applicable.
• Collaborate with Manufacturing, Quality Assurance, Engineering, Regulatory Affairs, and Technical Services teams to support project execution and commercial readiness.
• Prepare complex technical documentation, including validation protocols, characterization studies, technical reports, investigations, change controls, validation reports, and scientific documentation.
• May contribute as a lead author to scientific publications, technical reports, or complex scientific documents.
• Lead department-wide initiatives, including safety programs, recruiting efforts, technical committees, and organizational improvement activities.
• Mentor junior scientists and contribute to technical development and knowledge sharing within the organization.
• Make proactive scientific decisions that support project milestones, timelines, and business objectives.
• Develop detailed project plans including:
• Project timelines
• Milestones
• Experimental approaches
• Expected outcomes
• Resource requirements

Preferred Qualifications

Candidates with the following experience will be highly preferred:

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with:
• Aseptic filling operations
• Process characterization
• Process validation (PPQ)
• Technology transfer
• Commercial process support
• Experience authoring and executing:
• Validation protocols
• Characterization studies
• Technical reports
• Investigations
• Change controls
• Strong knowledge of:
• GMP requirements
• Aseptic processing principles
• Contamination Control Strategy (CCS)
• Pharmaceutical Quality Systems
• Experience supporting process optimization using statistical analysis tools such as JMP or Minitab.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically justified improvements.
• Experience working with:
• Single-use technologies
• Filling equipment
• Sterile manufacturing operations
• Experience supporting process improvement initiatives and continuous manufacturing readiness.

Minimum Qualifications

Candidates must meet one of the following education and experience combinations:

• Doctorate degree (Ph.D., Pharm.D., or M.D.) in a scientific discipline with relevant postdoctoral experience when applicable.

OR

• Master’s degree with a minimum of 3 years of relevant scientific experience.

OR

• Bachelor’s degree with a minimum of 5 years of relevant scientific experience.

Preferred Educational Background

Preferred degrees include:

• Chemical Engineering
• Mechanical Engineering
• Biomedical Engineering
• Bioprocess Engineering
• Pharmaceutical Sciences
• Biotechnology
• Biology
• Microbiology
• Other related Life Sciences disciplines

Required Skills & Competencies

• Demonstrated ability to lead, motivate, mentor, and/or supervise technical teams.
• Strong project planning and time management skills with the ability to develop realistic timelines and achieve project milestones.
• Ability to solve complex technical problems through application of scientific theory and data-driven approaches.
• Proven ability to independently develop scientific analyses, experimental strategies, and technical solutions.
• Ability to exercise sound scientific judgment and work effectively with minimal supervision.
• Strong laboratory, technical, and project management experience.
• Creative problem-solving skills with the ability to develop new scientific hypotheses and innovative experimental approaches.
• Strong analytical skills with the ability to critically evaluate and interpret complex scientific data.
• Understanding of scientific and technical principles related to assigned projects and manufacturing processes.
• Excellent written and verbal communication skills.
• Strong technical writing and presentation skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment.
• Experience collaborating with cross-functional teams including Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Proficiency with Microsoft Office applications including Excel, Word, and PowerPoint.
• Experience with statistical analysis software such as JMP or Minitab.
• Experience with laboratory data systems such as LIMS and HLEE.
• Fully bilingual in English and Spanish.

Functional Responsibilities

1. Independently monitor and conduct experiments, studies, and research activities to advance projects, technologies, and process improvements.
2. Provide advanced data analysis, interpretation, and recommendations based on experimental results.
3. Assess scientific data impact on projects and recommend appropriate technical solutions.
4. Expand knowledge beyond primary expertise to support innovation and technology advancement.
5. Identify relevant external scientific knowledge, technologies, and competitive developments.
6. Independently prepare new and innovative protocols and experimental designs.
7. Serve as a key contributor or technical leader within research and project teams.
8. Initiate productive collaborations across departments and external organizations.
9. Introduce advanced technologies, methodologies, and scientific concepts.
10. Prepare complex technical documentation, scientific reports, validation documents, and technical publications when applicable.
11. Lead department-wide support initiatives, including safety, recruiting, and technical committees.
12. Develop mentoring and leadership capabilities by supporting junior technical personnel.
13. Make proactive scientific decisions that contribute to successful project execution and milestone achievement.
14. Plan detailed project procedures including timelines, milestones, methodologies, expected outcomes, and required resources.

Technical Skills & Systems

• Process Development & Optimization
• Process Characterization Studies
• Process Validation (PPQ)
• Technology Transfer
• Sterile Manufacturing Operations
• Aseptic Processing
• Fill-Finish Operations
• Single-Use Technologies
• GMP Manufacturing
• Contamination Control Strategy (CCS)
• Scientific Data Analysis
• Technical Documentation
• Validation Protocol Development
• Investigation Reports
• Change Control Management
• JMP
• Minitab
• LIMS
• HLEE
• Microsoft Excel, Word, and PowerPoint