Process Development Sr. Scientist- 35534 (Validation & Documentation)

CIS International LLC; Juncos (PR); On-site; USD 85,000 - 115,000; Full time

Job summary

CIS International LLC in Juncos, PR seeks a Process Development Senior Scientist (Validation & Documentation) to independently conceive, design and advance experiments, interpret data and lead projects.

This on-site, 5-month contract requires strong GMP knowledge, experience with validation protocols, technical writing and collaboration across Manufacturing, Quality and Regulatory teams.

Qualifications

• Doctorate or equivalent with postdoctoral experience where applicable.
• Master's degree with 3+ years relevant scientific experience.
• Bachelor's degree with 5+ years relevant scientific experience.
• A degree in Mechanical/Chemical/Biomedical/ Biotechnology or related science preferred.
• Experience with data analysis, MS Office, JMP or Minitab, LIMS/HLEE.

Responsibilities

• Independently conducts experiments to advance projects.
• Provides advanced data analysis and interpretation.
• Leads collaborations and mentors team members.
• Plans procedures, milestones and resources for defined projects.
• Contributes to safety, quality, and documentation efforts.

Skills

Leadership

Timeline planning

Scientific analysis

Problem solving

Project management

Hypothesis development

Data interpretation

Lab skills

Bilingual English/Spanish

Education

PhD/MD/PharmD with postdoc (where applicable)

Master's degree with 3+ years relevant experience

Bachelor's degree with 5+ years relevant experience

Engineering/biomedical/science degree preferred

Proficiency with MS Office; JMP/Minitab; LIMS/HLEE

Tools

JMP

Minitab

LIMS

HLEE

Job description

Process Development Sr. Scientist- 35534 (Validation & Documentation)

SUMMARY: To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.

FUNCTIONS

• Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
• Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
• Expands knowledge-seeking beyond core area of expertise
• Identifies relevant external competitive knowledge
• Independently prepares new and novel protocols/experimental design
• Key contributor to an independent research/project team
• Initiates productive collaborations outside of the department or company
• Introduces new or advanced technologies and/or concepts
• May contribute to scientific journal articles or complex technical documents as lead author
• Leads department-wide support efforts such as safety, recruiting and committees
• Develops supervisory and mentoring skills
• Makes proactive decisions that contribute to the achievement of milestones
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.

EDUCATION

• Doctorate (PhD, PharmD, or MD) with relevant postdoctoral experience where applicable.
• Master's degree with 3+ years of relevant scientific experience.
• Bachelor's degree with 5+ years of relevant scientific experience.
• A degree in Mechanical Engineering, Chemical Engineering, Biomedical Engineering, Bioprocess Engineering, Pharmaceutical Sciences, Biotechnology, Biology, Microbiology, or a related scientific discipline is highly preferred.
• In addition to the minimum educational requirements listed below, candidates should have experience with technical data analysis and scientific documentation. Proficiency with Microsoft Office (Excel, Word, and PowerPoint) is required. Experience with statistical software (JMP or Minitab) and Sample Management System such as LIMS and HLEE.

PREFERRED QUALIFICATIONS

• 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, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality, Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.

SKILLS

• Ability to motivate, lead and/or supervise the activities of others.
• Ability to develop realistic timelines.
• Be able to problem solve using the application of scientific theory.
• Demonstrate skills in independently determining and developing scientific analysis and solutions.
• Exercise considerable latitude in determining objectives of scientific work.
• Demonstrate strong laboratory and project management skills.
• Creative skills in the development of new hypotheses for scientific experiments.
• Critical evaluation and detailed interpretation of results.
• Demonstrate knowledge of scientific relevance of targeted work.
• Bilingual (English and Spanish).

WORK METHODOLOGY

• Full on site job in Juncos, PR
• Full time job
• Expected project duration: 5months for the first contractwith a high possibility of extension based on performance and budget.
• Administrative Shift:Monday–Friday, 8:00 am– 5:00 pm (or standard business hours). Availability to work on weekends as needed. All shifts.
• Expected hiring date: August 2026