Job Description

The Process Development Principal Scientist Lead functions as a high‑level scientific and technical resource with cross‑functional impact across Process Development, Manufacturing, Engineering, Quality, and Validation. This role develops and leads scientific programs, drives innovative experimental strategies, and guides the successful completion of major projects. Operating with significant independence, the Senior Scientist anticipates complex technical challenges, develops novel solutions, and introduces new technologies and concepts to advance departmental and organizational objectives.

Key Responsibilities

• Serve as the lead scientific/technical expert within the function or department.
• Develop novel experimental strategies, scientific approaches, and innovative solutions to complex technical problems.
• Introduce new technologies, concepts, and methodologies that enhance scientific capability and operational efficiency.
• Apply deep knowledge of drug discovery, development processes, and regulated environments to guide departmental strategy.
• Anticipate scientific and technical challenges and develop practical, innovative solutions.
• Lead PD‑related project management activities, including planning, implementation, monitoring, completion, and follow‑up.
• Develop project plans, strategies, timelines, and resource allocations in collaboration with project managers and SMEs.
• Support development of comprehensive business cases, including technical and financial analyses.
• Identify project risks, schedule changes, and resource constraints; implement solutions to maintain scientific efficiency and client satisfaction.
• Balance competing priorities and timelines, ensuring project deliverables meet quality and quantity standards.
• Provide leadership in schedule development, facilitation, collaboration, and project follow‑up.
• Manage contractors, vendors, and cross‑functional project teams.
• Work closely with manufacturing, process engineering, maintenance, quality assurance, and validation to implement projects and resolve scientific/technical issues.
• Integrate activities across departments with minimal oversight, ensuring alignment with functional and organizational goals.
• Communicate scientific and technical information to diverse audiences, including senior management and external scientific communities.
• Independently evaluate, select, and apply standard engineering and scientific techniques.
• Perform assignments requiring investigation of multiple variables and clear, specific objectives.
• Apply Lean Six Sigma, operational excellence, and continuous improvement methodologies to assigned projects.
• Ensure strict adherence to cGMP, GLP, internal policies, and regulatory requirements throughout the project lifecycle.
• Document all activities according to cGMP standards, including training compliance.
• Lead teams contributing to departmental, project, and product objectives.
• Coach, mentor, and motivate colleagues, providing scientific, technical, and career guidance.
• Demonstrate strong leadership, conflict resolution, negotiation, and team‑building skills.
• Present scientific and technical information to large groups and external networks.

Skills

• Working knowledge of pharmaceutical/biotech processes and regulated documentation.
• Ability to interpret and apply GLPs, GMPs, and regulatory requirements.
• Expertise with specialized laboratory equipment and scientific software.
• Strong analytical problem‑solving skills, including hypothesis development and scientific reasoning.
• Ability to manage multiple complex projects simultaneously.
• Advanced project management skills and financial analysis capability.
• Technical writing, report development, and scientific presentation skills.
• Ability to interact effectively across diverse communication and working styles.
• Ability to determine when additional internal resources are required to solve problems.
• Advanced technical expertise in at least one specialty area.

Requirements

Education

• PhD / PharmD / MD + 2 years of scientific or engineering experience
• Master’s degree + 5 years of scientific or engineering experience
• Bachelor’s degree + 7 years of scientific or engineering experience

Preferred Qualifications

• Demonstrated leadership in scientific project management within pharmaceutical/biotech environments.
• Experience supporting inspection‑related project management activities.
• Strong cross‑functional collaboration with manufacturing, engineering, QA, and validation.
• Proven ability to develop business cases including technical and financial components.
• Ability to maintain scientific efficiency and quality under evolving project demands.
• Flexibility to support extended hours, non‑standard shifts, and 24/7 operational needs.
• Strong negotiation, facilitation, conflict resolution, and vendor management skills.
• Excellent communication and presentation skills, including external networking and large‑group presentations.
• Demonstrated ability to motivate teams and communicate scientific vision effectively.

Benefits

• 6-month contract with possible extension
• Administrative shift