Process Development Scientist

Flexible & Integrated Technical Services, LLC•Juncos, PR

2d•Onsite

About The Position

This role is for a Data Analysis position within the DP PD Process Monitoring & Digital Development team. The ideal candidate will have a strong technical background in life sciences or engineering, with experience in a regulated pharmaceutical environment. The position requires analytical problem-solving skills, project management abilities, and experience with laboratory equipment and validation processes. The company culture emphasizes teamwork, ethics, and the scientific method, offering a dynamic environment for a creative and scientifically-minded individual.

Requirements

Bachelor's Degree in Life Sciences or Engineering (statistics, mathematics, systems engineering, industrial engineering, computer science, or related field experience)
Four (4) years of experience in a Scientist role within the pharmaceutical or regulated industry.
Bilingual (English & Spanish).
Project Management skills
Analytical problem-solving skills
Experience in equipment commissioning and qualification, validation and documentation processes in a highly regulated environment.
Experience using laboratory equipment (i.e., stereomicroscopes, calipers, X-Ray/CT Scan Equipment, Instron Machine, etc.).
Knowledge of company policies and procedures to ensure a continuous state of compliance.

Nice To Haves

Multitasking skills
Scientific skills
Creative skills
Ability to work in an environment of healthy competition and teamwork
Ethical conduct
Use of the scientific method

Responsibilities

Monitors field of expertise, including literature and technology development, and communicates relevant observations.
Understands and interprets primary components specifications and methods.
Demonstrates knowledge regarding metal, glass and polymer formation process and primary container components defects and classifications.
Performs Primary Packaging Evaluations and Glass/Polymers Forensic Analysis.
Introduce advanced scientific methods.
Develop and implement new and novel protocols to address specific issues.
Represent the department on project teams under supervision.
Initiate productive collaborations within and outside of the Process Development Department.
Advises or assists others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies.
Independently authors scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents.
Participate with the external scientific community.
Assume lead role in department-wide support efforts such as safety, OE and other committees.
Develops and follows timelines for completing project teamwork.
Conduct research into the structures and properties of materials, such as metals, polymers, and ceramics to obtain information that could be used to develop new products or enhance existing ones.
Determine ways to strengthen or combine materials or develop new materials with new or specific properties for use in a variety of products and applications.
Develop testing methods to evaluate the effects of various conditions on containers materials.
Plan laboratory experiments to confirm feasibility of processes and techniques used in the production of materials having special characteristics.
Perform experiments, records, organize data and analyze results under minimal supervision.
Generates robust and reliable data in compliance with the respective protocols, methods or SOPs.