Process Development Scientist

Experience either in process validation or manufacturing operations. Should be able to develop strategies and mixing studies development. Also equipment qualification expertise is required. Candidates which previous background is only in computer validation or automation does not have the experience require for this position.

OR

Preferred qualification experience with Inspection Development process.
Basic Knowledge in statistics using Minitab or other statistical software
Project Management Skills
Knowledge in development documentation protocols and reports
Excellent Communication and Teamwork skills

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. Doctorate degree or Masters degree and 5 years of Scientific experience or Bachelors degree and 6 years of Scientific experience.

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 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 cGMPs. Fully bilingual (English/Spanish).

Job Types: Full-time, Contract

Salary: $49.00 - $51.00 per hour

Expected hours: 40 – 45 per week

Schedule:

• 8 hour shift
• Monday to Friday
• Overtime
• Weekends as needed

Experience:

• Process Validation: 5 years (Preferred)
• Manufacturing Operations: 5 years (Preferred)
• Inspection Development Process: 5 years (Preferred)
• Statistics: 3 years (Preferred)
• Documentation Protocols and Reports: 5 years (Preferred)

Work Location: In person