Process Development Scientist (30938) – Juncos, PR

Doctorate degree in Sciences/Engineering or Master’s degree in Sciences/Engineering and 3 years of directly related experience or Bachelor’s degree in Sciences/Engineering and 5 years of directly related experience.
Scope
Conceive, design, implement and execute specific scientific experiments, which contribute to the successful completion of goals and/or projects. Provides input to new processes to generate robust and reliable data and ensures that studies are conducted in compliance with the respective protocol and applicable guidelines and regulations. Specific responsibilities include but are not limited to:

• Introduces new or advanced technologies and/or concepts (equipment and process design)
• Independently lead, plan, and execute experiments, studies, or a series of experiments / studies to advance projects or technologies (equipment commissioning, equipment characterization, equipment qualification, equipment validation, process characterization, process validation)
• Provides advanced data analysis and interpretation, assesses impact of the data on the project and implements recommendations
• 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
• Initiates 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, and complex regulatory documents
• May author invention disclosure submissions and/or patents
• Leads role in department-wide support efforts such as safety, recruiting and committees
• Develops supervisory and mentoring skills
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources
• Makes and communicates proactive decisions that contribute to the achievement of milestones
• Support non-standard operations including extended hours and/or weekends, as per business needs

Preferred qualifications

• Educational background in Life Science and/or Engineering
• Demonstrated leadership skills, initiative and self-motivation
• Proficient in English and Spanish communication skills. Interacts effectively with variety of communication and working styles
• Knowledge and/or experience of GMP regulations
• Technical Writing
• Demonstrated strong problem solving and conflict resolution
• Excellent time and project management skills to deliver projects on time and budget
• Team player with strong negotiation skills to work with multidisciplinary teams that relies on collaboration for effective decision-making
• Design, Commissioning, Characterization, Qualification & Validation (equipment or process) experience
Administrative Shift
Non-Standard Shift
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 team work.
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).