Process Development Scientist (biotechnology Industry) 3373211

ProQuality Network; Northern (KY); Hybrid; USD 90,000 - 120,000; Full time

Job summary

ProQuality Network is seeking a Process Development Scientist to support biotechnological project goals. The role involves conceiving, designing, implementing and executing experiments under supervision to deliver compliant results within project timelines.

Ideal candidates have Ph.D. or Master’s degree with relevant experience in life sciences or engineering, and a strong background in protein science, CGMP, and data interpretation.

Qualifications

• Ph.D. preferred or equivalent experience.
• Life Sciences or Engineering background required.

Responsibilities

• Design, execute, and evaluate experimental strategies.
• Generate and interpret robust scientific data for project objectives.
• Ensure studies comply with protocols and regulatory requirements.
• Author scientific reports and regulatory documents.
• Mentor junior staff where applicable.

Skills

Spanish-English bilingual

Strong communication

Project management

Scientific troubleshooting

Education

Ph.D. in Chemical/Biological field

M.S. + 2 years relevant experience

B.S. + 4 years relevant experience

Tools

Microsoft Office

JMP

Minitab

Job description

Process Development Scientist (biotechnology Industry) 3373211

Job Title: Process Development Scientist 3373211

Location: East of Puerto Rico (Open to Puerto Rico Residents)

Work Schedule: 100% Onsite | Administrative Shift

Duration: Approximately 6 months

Open Position: 2

Summary:

We are seeking a Process Development Scientist to support our client in the biotechnology industry. This role is responsible for conceiving, designing, implementing, and executing scientific experiments to support the successful completion of project goals. The candidate will work under the general guidance of a supervisor and contribute to key development activities in alignment with regulatory standards and project timelines.

Key Responsibilities:

• Design, execute, and evaluate experimental strategies with minimal supervision.


• Generate and interpret robust, reliable scientific data to support project objectives.


• Ensure studies are conducted in compliance with protocols, guidelines, and regulatory requirements.


• Analyze and interpret data; assess the impact of findings on ongoing projects.


• Stay current with developments in scientific expertise and related technologies.


• Implement innovative experimental methods and protocols.


• Represent the department on cross-functional teams and support project timelines.


• Collaborate effectively within and outside the department to support scientific and operational objectives.


• Author scientific reports, regulatory documents, and intellectual property submissions.


• Provide technical guidance and mentoring to junior staff when applicable.


• Participate in department initiatives, including safety, recruiting, and cross-functional committees.

Preferred Qualifications:

• Experience in formulation and filling processes is highly preferred (not required if holding a Ph.D.).


• Academic background in Life Sciences or Engineering (e.g., Biochemistry, Chemical Engineering).


• Strong background in protein science and biopharmaceutical manufacturing processes.


• Proficiency in process monitoring, statistical tools, and data interpretation.


• Hands-on experience in technology transfer and the process validation lifecycle.


• Experience supporting deviations, product impact assessments, and manufacturing floor support.


• Bilingual proficiency in Spanish and English.


• Strong communication, project management, and problem-solving skills.


• Proficiency with Microsoft Office, JMP, and/or Minitab.

Education Requirements:

• Doctorate (Ph.D.) OR


• Master’s degree + minimum 2 years of relevant scientific experience OR


• Bachelor’s degree + minimum 4 years of relevant scientific experience.


• Relevant fields include: Chemical Engineering, Mechanical Engineering, Chemistry, Biology, or related disciplines.

Competencies and Skills:

• Advanced skills in scientific analysis and troubleshooting.


• Strong laboratory techniques and experimental design capabilities.


• Demonstrated ability to lead or mentor junior team members.


• Effective communication across multidisciplinary teams.


• Competence in technical writing, problem-solving, project management, and conflict resolution.


• Adaptability to change and ability to manage multiple priorities.


• Strong knowledge of cGMP and regulatory standards.


• Fully bilingual (English/Spanish).