Process Development Scientist-35500

CIS International•Juncos, PR

12d•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. This role involves conceiving and designing, executing or evaluating, and interpreting experimental strategies. The scientist will provide input to new processes to generate robust and reliable data and ensure studies are conducted in compliance with respective protocols and applicable guidelines and regulations. The position requires designing, monitoring or conducting experimental strategies with general guidance from a supervisor, providing data analysis and interpretation, and assessing the impact of the data on the project. The scientist will stay current in their field of scientific expertise and relevant areas, monitoring literature and technology development, and communicating relevant observations. They may introduce advanced scientific methods, develop and implement new and novel protocols, and may represent the department on project teams under supervision. Productive collaborations within and outside the department or company are encouraged. The role involves advising or assisting others in experimental design and/or interpretation/diagnosis of data and implementing innovative remedies. The scientist will independently author scientific reports, summary documents, complex regulatory documents, invention disclosure submissions and/or patents, and participate in the external scientific community. They may also assume lead roles in department-wide support efforts such as safety, recruiting, and committees, and may develop supervisory and mentoring skills. Developing and following timelines for completing project team work is essential.

Requirements

Doctorate or Master's + 2 years of Scientific experience.
Bachelors + 4 years of Scientific experience.
Advanced scientific analysis and troubleshooting skills.
Advanced laboratory work skills.
Ability to motivate and/or supervise the activities of others.
Must be well organized, have multi-task project experience, and be able to communicate and work well with other departments.
Must have demonstrated skills and competencies in the following areas: Verbal communication, Written communication including technical writing skills, negotiation and conflict resolution.
Analytical problem solving
Project management.
Ability to be flexible and manage change.
Computer literacy (Windows environment: Word, Excel, Power Point).
Skills requiring the application of scientific theory.
Creative skills in the design and performance of scientific experiments and interpretation of results.
Strong knowledge of cGMP
Fully bilingual (English/Spanish).

Nice To Haves

Experience in drug product manufacturing.
Process Validation Writing technical protocols or reports.

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.