Process Development Scientist 35470

ProQuality Network; United States; Hybrid; USD 85,000 - 125,000; Full time

Job summary

ProQuality Network seeks a Process Development Scientist to support scientific studies and manufacturing initiatives in a commercial biopharmaceutical setting. You will design, execute, analyze, and interpret experiments to drive process development, manufacturing support, and continuous improvement.

The ideal candidate has experience in biopharma manufacturing, including formulation and aseptic filling, and strong skills in data analysis, technical writing, project management, and

Qualifications

• Master's or PhD with 2+ years relevant scientific experience or, alternatively, a Bachelor with 4+ years relevant experience.
• Experience in biopharmaceutical manufacturing, especially formulation and aseptic filling.
• Strong writing and data analysis skills, with knowledge of cGMP requirements.

Responsibilities

• Design, execute, monitor, and evaluate scientific experiments and process development strategies under supervision.
• Analyze data, interpret results and assess impact on manufacturing processes.
• Prepare technical reports and regulatory documents with accuracy.

Skills

Analytical thinking

Project management

Cross-functional teamwork

Technical writing

Problem solving

Regulatory compliance

Communication skills

Biopharma manufacturing

Education

Bachelor in Life Sciences or Engineering

Master in Life Sciences or Engineering

Doctoral degree in Life Sciences or Engineering

Tools

JMP

Job description

Tittle: Process Development Scientist (Job ID: 35470)

Work Schedule: Hybrid | Administrative Shift (Availability to support 24/7 manufacturing operations as needed)

Contract Duration: 5 Months

Open Positions: 2

Position Summary

Our client is seeking a Process Development Scientist to support scientific and manufacturing initiatives within a commercial biopharmaceutical environment. This role is responsible for designing, executing, analyzing, and interpreting scientific studies that contribute to process development, manufacturing support, and continuous improvement. The successful candidate will apply scientific expertise to generate reliable data, troubleshoot technical challenges, support manufacturing operations, and ensure compliance with regulatory and quality requirements.

The ideal candidate has experience in biopharmaceutical manufacturing, particularly in formulation and aseptic filling operations, and demonstrates strong analytical, technical writing, project management, and cross-functional collaboration skills.

Preferred Qualifications

• Bachelor's, Master's, or Doctoral degree in Life Sciences or Engineering (e.g., Biochemistry, Chemical Engineering, Biotechnology, or a related discipline).
• Experience supporting commercial biopharmaceutical manufacturing operations, preferably in formulation and aseptic filling.
• Understanding of protein science, formulation processes, and aseptic manufacturing operations.
• Experience with process monitoring, data trending, and statistical analysis tools such as JMP.
• Experience supporting manufacturing deviations, investigations, root cause analysis (RCA), and product impact assessments.
• Ability to provide manufacturing floor support in a fast‑paced, 24/7 production environment.
• Strong technical writing skills, including preparation of scientific and regulatory documentation.
• Excellent analytical, problem-solving, communication, presentation, and project management skills.
• Proven ability to collaborate effectively with cross-functional teams.
• Fully bilingual in English and Spanish (written and verbal).

Key Responsibilities

Scientific & Process Development

• Design, execute, monitor, and evaluate scientific experiments and process development strategies under general supervision.
• Develop experimental approaches that generate accurate, reliable, and reproducible data.
• Analyze scientific data, interpret results, and evaluate the impact on project objectives and manufacturing processes.
• Develop and implement new scientific methods, protocols, and innovative solutions to address technical challenges.
• Apply scientific principles to support process optimization and continuous improvement initiatives.
• Remain current with scientific literature, emerging technologies, and industry best practices, communicating relevant findings to the team.

Manufacturing & Technical Support

• Provide technical support for commercial manufacturing operations, including formulation and aseptic filling processes.
• Assist in troubleshooting manufacturing issues and support investigations to identify root causes and implement effective solutions.
• Support process monitoring activities by reviewing performance data, identifying trends, and recommending process improvements.
• Ensure all studies and activities comply with approved protocols, cGMP requirements, and applicable regulatory guidelines.

Documentation & Regulatory Compliance

• Prepare scientific reports, technical summaries, regulatory documentation, and other technical documents with accuracy and attention to detail.
• Independently author complex scientific reports and documentation supporting manufacturing and development activities.
• Support regulatory inspections and audit readiness by maintaining high-quality documentation and technical records.
• Ensure compliance with company procedures, quality systems, and regulatory expectations.

Cross-Functional Collaboration

• Collaborate with Manufacturing, Quality, Engineering, Process Development, and other functional teams to support project execution.
• Participate in project teams and contribute scientific expertise to achieve project milestones and organizational goals.
• Provide technical guidance on experimental design, data interpretation, and scientific problem-solving.
• Foster productive working relationships across departments and support collaborative decision‑making.
• Support department initiatives related to safety, operational excellence, recruiting, and continuous improvement efforts.
• Develop project timelines and ensure deliverables are completed according to established schedules.
• Mentor team members and assist in developing technical capabilities when appropriate.
• Represent the department on project teams and within the broader scientific community as needed.

Education Requirements

Candidates must meet one of the following qualifications:

• Master's degree with a minimum of two (2) years of relevant scientific experience; or
• Bachelor's degree with a minimum of four (4) years of relevant scientific experience.

Scientific & Technical Skills

• Advanced scientific analysis and technical troubleshooting.
• Strong laboratory and experimental design skills.
• Ability to apply scientific principles to solve complex technical challenges.
• Experience interpreting experimental data and translating findings into actionable recommendations.
• Strong understanding of cGMP manufacturing requirements.

Manufacturing & Quality

• Process Development
• Process Monitoring
• Scientific Data Analysis
• Root Cause Analysis (RCA)
• Manufacturing Investigations
• Deviation Support
• Product Impact Assessments
• Regulatory Compliance
• cGMP Manufacturing

Communication & Project Management

• Excellent verbal and written communication skills.
• Strong technical writing and documentation capabilities.
• Effective presentation and interpersonal communication skills.
• Project planning and time management.
• Organizational and multitasking skills.
• Negotiation and conflict resolution abilities.
• Ability to work independently and collaboratively within cross‐functional teams.
• Strong interpersonal and relationship‑building skills.
• Adaptability and flexibility in a dynamic manufacturing environment.
• Ability to mentor, motivate, and support team members.

Computer Skills

• Microsoft Word
• Microsoft Excel
• Microsoft PowerPoint
• Windows‑based applications
• Statistical analysis software (JMP preferred)