Process Development Scientist

BioPharma Consulting JAD Group

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. 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. May develop supervisory and mentoring skills. Develops and follows timelines for completing project teamwork.

Requirements

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).
Doctorate OR Master + 2 years of Scientific experience OR Bachelors + 4 years of Scientific experience.
Highly prefer Engineering Degree.

Nice To Haves

Experience with Inspection Development process.
Basic Knowledge in statistics using Minitab, JMP or other statistical software
Project Management Skills
Knowledge in development documentation protocols and reports
Excellent Communication and Teamwork skills
Good Documentation Practices
Quality and Compliance Oriented
Computer literate including proficient use of AI tools

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.
May develop supervisory and mentoring skills.
Develops and follows timelines for completing project teamwork.