Process Development Scientist at BioPharma Consulting JAD Group

Juncos, , Puerto Rico -

Full Time

Start Date

Immediate

Expiry Date

22 Dec, 25

Salary

0.0

Posted On

23 Sep, 25

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Process Development, Scientific Experimentation, Data Analysis, Protocol Development, Project Management, cGMP Regulations, Validation Processes, Technical Writing, Risk Assessment, Collaboration, Mentoring, Communication, Equipment Characterization, Testing Strategies, Problem Solving, Bilingual

Industry

Biotechnology Research

Description

We are seeking a Process Development Scientist to lead and support scientific experimentation, equipment characterization, and validation activities within a regulated manufacturing or packaging environment. This role involves designing and executing experimental strategies, analyzing data, and developing robust protocols to support equipment implementation and process optimization. The ideal candidate will bring deep technical expertise, strong project management skills, and the ability to collaborate across multidisciplinary teams. Key Responsibilities Conceive, design, and execute scientific experiments under general guidance. Analyze and interpret experimental data to assess impact on project goals. Develop and implement novel protocols to address specific technical challenges. Ensure studies are conducted in compliance with applicable guidelines and regulations. Monitor scientific literature and technology trends relevant to the role. Lead development and execution of equipment characterization strategies. Design and implement testing protocols, including SATs and challenge validations. Author technical reports, validation documentation, and risk assessments. Apply QRAES methodology to support risk-based decision making. Support new equipment installations through validation planning and execution. Collaborate with internal departments to support project execution and troubleshooting. Represent the department on project teams and contribute to cross-functional initiatives. Mentor junior staff and contribute to department-wide efforts such as safety and recruiting. Communicate project status and findings effectively to stakeholders. Education & Experience Doctorate degree OR Master’s degree with 5 years of scientific experience OR Bachelor’s degree with 6 years of scientific experience Technical & Software Requirements Proficiency in Microsoft Word, Excel, and PowerPoint Strong knowledge of cGMP regulations and validation processes Experience with vision system technologies and inspection/packaging concepts Fully bilingual in English and Spanish Preferred Qualifications Expertise in equipment and process characterization Experience developing testing strategies and validation protocols Strong technical writing and documentation skills Familiarity with risk assessment methodologies (e.g., QRAES) Ability to solve routine technical problems and manage change effectively Strong verbal communication, negotiation, and conflict resolution skills Project management experience in a regulated environment 5-month contract Administrative Shift

Responsibilities

The Process Development Scientist will lead scientific experimentation and equipment characterization in a regulated environment. This includes developing protocols and collaborating with multidisciplinary teams to optimize processes.