Apply to 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: 5 months for the first contract with 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