Process Development Scientist

Under general supervision, the Senior Scientist conceives, designs, implements, and executes scientific experiments and technical strategies that support commercial biopharmaceutical manufacturing operations. This role contributes to the successful completion of projects through experimental design, data analysis, regulatory documentation, and direct manufacturing floor support in a fast-paced, 24/7 environment.

Key Responsibilities

• Conceive, design, execute, evaluate, and interpret experimental strategies.
• Develop and implement new or improved scientific methods and protocols.
• Provide scientific input to enhance process robustness and data reliability.
• Monitor scientific literature and emerging technologies relevant to the function.
• Independently author scientific reports, summary documents, regulatory submissions, and technical documentation.
• May contribute to invention disclosures and patents.
• Support commercial biopharmaceutical manufacturing, particularly formulation and aseptic filling operations.
• Provide real-time technical support on the manufacturing floor.
• Conduct process monitoring, data trending, and statistical analysis (e.g., JMP).
• Support deviations, investigations, root cause analysis, and product impact assessments.
• Ensure all studies and activities comply with approved protocols, cGMP standards, and regulatory guidelines.
• Represent the department on project teams under senior scientific supervision.
• Collaborate with Manufacturing, Quality, Regulatory, and Engineering teams.
• Advise and mentor colleagues in experimental design and data interpretation.
• Develop timelines and manage project deliverables.
• Participate in departmental initiatives such as safety, recruiting, and committee support.

Competencies & Skills

• Advanced scientific analysis and troubleshooting skills.
• Strong laboratory and experimental design capabilities.
• Strong knowledge of cGMP regulations.
• Analytical problem-solving and critical thinking skills.
• Project management and multi-tasking ability.
• Excellent verbal and written communication skills (including technical writing).
• Negotiation and conflict resolution skills.
• Ability to supervise, mentor, or motivate others.
• Adaptability and ability to manage change.
• Proficiency in Microsoft Office (Word, Excel, PowerPoint).
• Ability to work effectively in a fast-paced, 24/7 operational environment.

Requirements:
Education & Experience

• Doctorate (PhD) in Life Sciences or Engineering
OR
• Master’s degree + 2 years of relevant scientific experience
OR
• Bachelor’s degree + 4 years of relevant scientific experience

Preferred Qualifications

• Experience in a commercial biopharmaceutical manufacturing environment, preferably supporting formulation and aseptic filling.
• Strong understanding of protein science, formulation development, and filling processes.
• Experience with statistical tools and data analysis software (e.g., JMP).
• Experience preparing documentation for regulatory audits.
• Strong technical writing skills.
• Bilingual proficiency in English and Spanish (written and verbal).

Benefits:
• 9-month contract
• Administrative Shift