Process Development Scientist- 35336

CIS International•Juncos, PR

13d•Onsite

About The Position

To conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects under general guidance of supervisor. Conceives and designs, executes or evaluates, and interprets experimental strategies. Provides input to new processes to generate robust and reliable data. Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Designs, monitors or conducts experimental strategies with general guidance from supervisor. Provides data analysis and interpretation, and assesses impact of the data on the project. Keeps current in field of scientific expertise and areas relevant to their function. Monitors field of expertise, including literature and technology development, and communicates relevant observations. May introduce advanced scientific methods. Develops and implements new and novel protocols to address specific issues. May represent the department on project teams under supervision of a senior scientific staff member. May initiate productive collaborations within and outside of the department or company. 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. Participates in external scientific community. May assume lead role in department-wide support efforts such as safety, recruiting and committees. May develop supervisory and mentoring skills. Develops and follows timelines for completing project team work.

Requirements

Doctorate in Materials Sciences / Engineering / Physics / Sciences.
Master in Materials Sciences / Engineering / Physics / Sciences+ 2 years of Scientific experience.
Bachelors in Materials Sciences / Engineering / Physics / Sciences + 4 years of Scientific experience.
Materials Sciences / Engineering / Physics / Sciences.
Knowledge of the practical application of engineering, sciences and technology.
Knowledge of arithmetic, algebra, geometry, calculus, statistics and their applications.
Knowledge of the chemical composition, structure, and properties of substances and of the chemical processes and transformations that they undergo.
Knowledge and prediction of physical principles, laws, interrelationships and applications to understanding fluid, material, and atmospheric dynamics and mechanical, electrical, atomic and sub- atomic structures and processes.
Understanding of equipment commissioning and qualification, validation and documentation processes in a highly regulated environment.
Advanced scientific analysis and troubleshooting skills.
Able to work in a laboratory environment.
Advanced laboratory work skills.
Experience using laboratory equipment (i.e., stereomicroscopes, calipers, XRay/ CT Scan Equipment, Instron Machine, etc.).
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
Ability to interpret and apply GMPs.
Adheres to company policies and procedures to ensure a continuous state of compliance.
Familiarity with documentation in a highly regulated environment.
Able to interact effectively with variety of communications and working styles.
Must have demonstrated skills and competencies in the following areas: Analytical problem-solving. Project management Operational Excellence Ability to be flexible and manage changes. Computer literacy (Windows environment: Word, Excel, Power Point).
Skills required the application of scientific method.
Creative skills in the design and performance of scientific experiments and interpretation of results.
Strong knowledge of cGMP’s.
Details oriented
Good teamwork skills.
Time management
Sense of urgency
Completion and follow-up.
Familiarized with electronic laboratory notebook systems.
Using scientific rules and methods to solve problems.

Nice To Haves

Educational background in Engineering and/or Sciences.
Knowledge in Material Sciences (glass/polymers).
Familiarity with Biopharmaceutical Environment.
Knowledge in Primary Packaging Components (vials, syringes, cartridges, etc.).
Knowledge in Secondary Packaging Components (labels, dispensing cartons, blisters, etc.)
Knowledge in Glass/Polymer Forensics.
Ability to motivate and/or supervise the activities of others.
Verbal communication, English and Spanish.
Written communication in English and Spanish including technical writing skills, negotiation, and conflict resolution.
Flexible schedule

Responsibilities

Conceives and designs, executes or evaluates, and interprets experimental strategies.
Provides input to new processes to generate robust and reliable data.
Ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations.
Designs, monitors or conducts experimental strategies with general guidance from supervisor.
Provides data analysis and interpretation, and assesses impact of the data on the project.
Keeps current in field of scientific expertise and areas relevant to their function.
Monitors field of expertise, including literature and technology development, and communicates relevant observations.
May introduce advanced scientific methods.
Develops and implements new and novel protocols to address specific issues.
May represent the department on project teams under supervision of a senior scientific staff member.
May initiate productive collaborations within and outside of the department or company.
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.
Participates in external scientific community.
May assume lead role in department-wide support efforts such as safety, recruiting and committees.
May develop supervisory and mentoring skills.
Develops and follows timelines for completing project team work.