Sr Technical Services Scientist (On-Site)

Purpose and Scope

Considered a technical leader within the organization having a specialized focus on initiatives for product, process and quality improvements encompassing all product lines. The person is responsible for providing scientific support for the QA/QC, regulatory, manufacturing, and development groups. Further, this person will lead investigations, determine root cause, and participate in the Corrective Action and Preventative Action (CAPA) process.

Essential Duties & Responsibilities

• Direct atypical and scientifically complicated research and is recognized as a thought-leader throughout the company.
• Perform process and formulation optimization for commercial product line to achieve financial goals of product improvement activities.
• Design and execute investigations that lead to root cause determination.
• Complete CAPA and corrective processes as needed throughout the company.
• Prepare scientific documentation describing and supporting process changes and improvements for regulatory submissions.
• Support process improvement efforts with designated projects in areas including formulations, optimization and scale-up.
• Serve as a company resource, providing broad technical direction. Review the work of less experienced employees and resolve problems.
• Make scientific recommendations to management as to the acceptability and quality of affected product lots.
• Oversee the generation and compilation of technical data required to support post approval changes.
• Assess the technical feasibility and serve as a technical liaison for incoming contract manufacturing/development work.
• Participate in required annual hazardous waste training, including container and tank management and inspections, generation of hazardous waste, and transfer of hazardous waste between lab procedure area, satellite accumulation and storage. Respond to spills per the Chemical Spill Procedures.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• Knowledge of principles associated with analytical, formulation and process development techniques encompassing skills associated with troubleshooting, process optimization and scale-up.
• Demonstrated solid technical leadership when working on complex problems within a technical scope in which analysis of situations or data requires an in-depth evaluation of various factors.
• Ability to lead and conduct technical investigations with minimal supervision.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Knowledge of ICH, SUPAC, and cGMP Guidelines.

Education & Experience

• Broad experience in pharmaceutical development, including over 15 years with a Bachelor of Science degree, more than 8 years with a Master's degree, or at least 5 years with a PhD.

Working Conditions

• Working conditions are typical for an office environment.
• Laboratory setting. May be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.