Process Development Scientist

BioPharma Consulting JAD Group

About The Position

The Scientist is responsible for conceiving, designing, implementing, and executing scientific and engineering experiments that support project objectives under general supervision. This role contributes to the development of robust processes, generation of reliable data, and advancement of scientific and technical capabilities within a regulated manufacturing environment.

Requirements

Doctorate degree in a relevant scientific or engineering discipline; OR Master’s degree with 2+ years of scientific or engineering experience; OR Bachelor’s degree with 4+ years of scientific or engineering experience.
Relevant fields include: Chemical Engineering, Mechanical Engineering, Biomedical Engineering, Materials Science, Pharmaceutical Sciences, or related disciplines.
Advanced scientific analysis, troubleshooting, and laboratory skills.
Strong understanding of cGMP requirements and regulated environments.
Demonstrated ability to manage multiple projects and meet timelines.
Strong verbal and written communication skills, including technical writing.
Analytical problem-solving and project management capabilities.
Ability to collaborate effectively across departments and disciplines.
Flexibility and ability to manage change in a fast-paced environment.
Computer proficiency in a Windows environment (Word, Excel, PowerPoint).
Creative approach to experimental design and interpretation of results.
Ability to motivate, mentor, and potentially supervise others.
Fully bilingual (English/Spanish).

Nice To Haves

Automated Visual Inspection (AVI) – Highly Desired
Hands-on experience with automated visual inspection systems, including:
Machine vision–based inspection platforms
Camera systems, lighting optimization, and optics
Image acquisition and defect detection logic
Experience with AVI system qualification and validation (IQ/OQ/PQ).
Performance qualification using defect kits.
Development or support of inspection recipes, defect libraries, and defect standards.
Optimization of inspection sensitivity and false reject rates.
Understanding of manual versus automated inspection correlation.
Data, Statistics & Digital Skills
Strong statistical background, including:
Sampling plans (AQL, zero acceptance, etc.)
Inspection capability studies
Measurement System Analysis (MSA)
Experience using data analysis tools such as JMP, Minitab, Python, or equivalent.
Ability to analyze large inspection datasets to trend defects, support process improvements, and inform inspection strategies.
Vision Systems Training (Preferred)
Experience with vision systems such as Cognex, Systech, Syntegon, Koerber, A3 CVP, and PDA 593.

Responsibilities

Conceive, design, execute, evaluate, and interpret experimental strategies.
Provide input to new and existing processes to generate robust, reliable, and reproducible data.
Ensure studies are conducted in compliance with approved protocols, regulatory requirements, and applicable guidelines.
Design, monitor, and conduct experimental strategies with general guidance from a supervisor.
Analyze data, interpret results, and assess the impact of findings on project goals.
Maintain current knowledge of scientific expertise through literature review, technology evaluation, and industry trends.
Introduce and apply advanced scientific and analytical methods as appropriate.
Develop, implement, and improve new or novel experimental protocols to address technical challenges.
Represent the department on cross-functional project teams under guidance of senior scientific staff.
Initiate and support internal and external technical collaborations.
Provide guidance to peers on experimental design, data interpretation, and problem resolution.
Independently author scientific reports, technical summaries, complex regulatory documentation, invention disclosures, and/or patent submissions.
Participate in the external scientific and technical community.
Support department-wide initiatives such as safety, recruiting, continuous improvement, and committee participation.
Develop project timelines and ensure timely completion of assigned deliverables.
May develop supervisory and mentoring skills.