Process Development Sr Scientist

ECHO Consulting Group; Juncos (PR); On-site; USD 95,000 - 150,000; Full time

Benefits offered by this job

Competitive compensation

Professional development

Job summary

ECHO Consulting Group in Juncos, PR seeks a highly motivated scientist to independently conceive, design, implement and advance experiments contributing to project goals and milestones.

You will lead technical activities, interpret data, collaborate across Manufacturing, Quality, Regulatory and Technical Services, and mentor junior staff while applying GMP and aseptic processing principles in sterile drug product manufacturing.

Qualifications

• Doctorate or PharmD or equivalent experience required.
• Experience in sterile drug product manufacturing preferred.
• Strong GMP knowledge and pharmaceutical quality systems.
• Experience with statistical analysis using JMP or Minitab and data-driven process optimization.

Responsibilities

• Independently monitors or conducts experiments to advance projects or technologies.
• Provides advanced data analysis and interpretation and assesses impact on the project.
• Develops and designs new protocols/experimental plans.
• Leads department-wide support efforts such as safety, recruiting and committees.
• Plans detailed procedures for defined projects with timelines and resources.
• Collaborates with cross-functional teams including Manufacturing, Quality, Regulatory and Technical Services.

Skills

Leadership

Experimental design

Data analysis

Regulatory knowledge

GMP compliance

Project management

Bilingual English/Spanish

Education

PhD or PharmD or Master+3 years science experience or Bachelor+5 years science experience

Job description

ECHO Consulting Group is a leader in providing solutions for the pharmaceutical, biotechnology, medical devices, and food industries. ECHO Consulting Group delivers high-quality solutions in CQV, quality management, regulatory compliance, manufacturing support, and project management. We are committed to offering exciting career opportunities in a workplace that values trust, respect, teamwork, creative talent, enthusiasm, and diligence. We are looking for talented professionals who are passionate about quality, collaboration, and delivering results. We believe great talent deserves great rewards. That’s why we offer a competitive compensation package and professional development.

Summary of Role:

To independently conceive, design, implement and advance scientific experiments, which contribute to the successful completion of goals and/or projects. Interprets experimental strategies or leads these activities. Provides input to new processes to generate robust and reliable data. Functions as a lead scientific / technical resource or as a project leader.

Responsibilities:

• Independently monitors or conducts experiments, studies, or a series of experiments/studies to advance projects or technologies
• Provides advanced data analysis and interpretation, and assesses impact of data on the project and makes recommendations
• Expands knowledge-seeking beyond core area of expertise
• Identifies relevant external competitive knowledge
• Independently prepares new and novel protocols/experimental design
• Key contributor to an independent research/project team
• Initiates productive collaborations outside of the department or company
• Introduces new or advanced technologies and/or concepts
• May contribute to scientific journal articles or complex technical documents as lead author
• Leads department-wide support efforts such as safety, recruiting and committees
• Develops supervisory and mentoring skills
• Makes proactive decisions that contribute to the achievement of milestones
• Plans detailed procedures for defined projects, including timelines, milestones, methodological approaches, expected results and necessary resources.

Shift:

Monday–Friday, 8:00 AM – 5:00 PM

Location:

Juncos, PR

Education:

Doctorate PhD OR PharmD OR -Masters + 3 years of Scientific experience OR -Bachelors + 5 years of Scientific experience.

Preferred Qualifications:

• Experience supporting sterile drug product manufacturing within the pharmaceutical or biotechnology industry.
• Hands-on experience with aseptic filling operations, process characterization, process validation (PPQ), technology transfer, and commercial process support.
• Experience authoring and executing validation protocols, characterization studies, technical reports, investigations, and change controls.
• Strong knowledge of GMP requirements, aseptic processing principles, contamination control strategy, and pharmaceutical quality systems.
• Experience performing statistical analysis using JMP or Minitab and applying data-driven approaches to process optimization.
• Ability to analyze manufacturing data, identify process trends, and recommend scientifically sound solutions.
• Experience working in cross-functional teams with Manufacturing, Quality,
• Engineering, Regulatory, and Technical Services.
• Strong technical writing, communication, presentation, and project management skills.
• Ability to independently manage multiple projects in a fast-paced manufacturing environment while supporting commercial readiness and continuous process improvement.
• Experience with single-use technologies, filling equipment, and sterile manufacturing operations is highly desirable.

Skills:

• Ability to motivate, lead and/or supervise the activities of others.
• Ability to develop realistic timelines.
• Be able to problem solve using the application of scientific theory.
• Demonstrate skills in independently determining and developing scientific analysis and solutions.
• Exercise considerable latitude in determining objectives of scientific work.
• Demonstrate strong laboratory and project management skills.
• Creative skills in the development of new hypotheses for scientific experiments.
• Critical evaluation and detailed interpretation of results.
• Demonstrate knowledge of scientific relevance of targeted work.
• Bilingual (English and Spanish).

Equal Employment Opportunity

ECHO Consulting Group, Inc. is committed to providing equal employment opportunity without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, age, disability, veteran status, or membership in any other class protected by federal, state, or local law.

We assure you that your opportunity for employment with ECHO Consulting Group, Inc. depends solely on your qualifications.