Process Development Scientist

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.

FUNCTIONS

• 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 teamwork.

COMPETENCIES/SKILLS

• 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 solvingProject 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).

• Doctorate degree in Sciences OR
• Master’s degree in sciences and 2 years of directly related experience experience OR
• Bachelor’s degree and 4 years of directly related experience experience.

Preferred Qualifications

• Background in sciences
• Experience in Regulated Industry
• Proficient in creating and executing validation and qualification documentation
• Provide support to vision inspection qualification and characterizations
• Requires excellent communication skills with suppliers and other sites
• A Plus: Knowledge in automated vision inspection systems
• A Plus: Knowledgeable in CSV. Support CQV documentation and execution

• Administrative Shift
• 6-month contract