Process Development Sr. Scientist

We are seeking a Process Development Sr. Scientist to support process development, process validation, technical documentation, and manufacturing support activities within a highly regulated manufacturing environment. This position offers the opportunity to work in a cross-functional setting, contributing to process improvements, validation initiatives, and commercial manufacturing readiness while ensuring compliance with quality and regulatory requirements.

Responsibilities

• Support process development, process characterization, and process validation activities.
• Author, review, and execute validation protocols, technical documentation, and validation reports.
• Support equipment qualification and validation activities in compliance with GMP requirements.
• Analyze process performance data, identify trends, and recommend process improvements using scientific and risk-based approaches.
• Collaborate with Manufacturing, Quality, Engineering, and other cross-functional teams to support manufacturing readiness and process optimization.
• Participate in investigations, root cause analysis, CAPA activities, and implementation of corrective actions.
• Support change control activities and technical documentation updates.
• Contribute to continuous improvement initiatives that enhance process robustness, compliance, and operational efficiency.
• Support manufacturing operations during validation, characterization, and other critical production activities, including flexibility to work alternate shifts or weekends when required.

Qualifications

• Doctorate (PhD, PharmD, or MD); OR Master's degree with 3+ years of relevant scientific experience; OR Bachelor's degree with 5+ years of relevant scientific experience.
• Degree in Engineering, Microbiology, or another related scientific discipline.
• Experience supporting validation activities in a highly regulated manufacturing environment.
• Experience developing and/or executing validation protocols and technical documentation.
• Knowledge of GMP requirements and quality systems.
• Strong analytical, technical writing, and problem-solving skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Willingness to work different shifts and weekends during characterization or validation activities.
• Experience supporting pharmaceutical, biotechnology, medical device, or other regulated manufacturing environments.
• Experience with process monitoring, process characterization, and continuous improvement initiatives.
• Knowledge of statistical tools such as Minitab or similar software.
• Experience with risk management methodologies and data analysis.
• Strong communication, organizational, and project management skills.

If you are passionate about process development, validation, and scientific problem-solving in a regulated manufacturing environment, we encourage you to apply.

Job Type: Full-time

Pay: $55.00 - $60.00 per hour

Education:

• Bachelor's (Preferred)

Experience:

• supporting validation activities: 5 years (Preferred)
• developing and/or executing validation protocols: 5 years (Preferred)
• GMP requirements and quality systems: 5 years (Preferred)
• characterization: 5 years (Preferred)
• supporting pharmaceutical, biotechnology, medical device: 5 years (Preferred)
• process monitoring: 5 years (Preferred)
• statistical tools such as Minitab or similar software: 5 years (Preferred)
• risk management methodologies: 5 years (Preferred)
• data analysis: 5 years (Preferred)

Work Location: In person