Process Development Scientist

Posted 5 Days Ago
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Juncos
Mid level
Consulting • Pharmaceutical
The Role
The Process Development Scientist is responsible for designing and executing scientific experiments, analyzing data, and developing new protocols. They ensure compliance with protocols and guidelines, represent the department in project teams, and may mentor others. The role involves extensive data analysis, literature review, and collaboration within and outside the company.
Summary Generated by Built In

Description:

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. 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 teamwork. 
Requirements: 
Doctorate degree or Master’s degree and 3 years of directly related experience or Bachelor’s degree and 5 years of directly related experience or Associate’s degree and 10 years of directly related 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 cGMP’s. Fully bilingual (English/Spanish).
Preferred Qualifications: 
• Strong Knowledge on Vision system technologies
• Inspection/packaging Concepts Knowledge
• Development and Execution of Processes Characterization
o Establish Testing Strategies
o Design / Development of Characterization Protocols
o Technical Reports Development
o Validations, and technical reports- To support SATs executions, document generation and challenge validations strategies

The Company
South San Francisco, CA
265 Employees
On-site Workplace
Year Founded: 2000

What We Do

MENTOR Technical Group is a team of highly educated, superior trained, and dedicated professionals with expertise and experience to provide a complete portfolio of technical support and solutions for the FDA-regulated industry. MENTOR Technical Group delivers solutions with a flexible cost-effective approach to meet your company’s needs. Our purpose is to help you bridge the gap between your business strategies and results, by balancing three major aspects: People, Regulatory and Compliance, and Technology.

MENTOR Technical Group’s objective is to deliver reliable tailored solutions—from consultation to becoming part of your staff. This proximity helps us develop customized frameworks to help you unlock the hidden value in your plants, facilities, equipment, and staff, while optimally integrating resources, regulations, and technology.

MENTOR Technical Group’s commitment begins by getting involved from the conceptual phase up to the implementation phase of your projects. Our management staff has unparalleled experience in both the operating and consulting industries. We have over 200 technical staff members, which allows for efficient project execution.

At MENTOR Technical Group, we deliver on our commitments—every time, on time. Our enthusiastic highly skilled workforce consistently meets or exceeds client expectations. We don’t just perform for our clients; we work with integrity. Our professional staff takes pride in their work and acts with a sense of ownership.

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