Sr Technical Services Scientist (On-Site)

Tolmar Careers•Windsor, CO

1d•Onsite

About The Position

The Sr Technical Services Scientist is a technical leader focused on product, process, and quality improvements across all product lines. The role provides scientific support to QA/QC, regulatory, manufacturing, and development groups, and leads investigations, root-cause determinations, and participation in corrective and preventive action processes. The scientist directs complex research, optimizes commercial product formulations and processes, and provides broad technical direction across the company. The position also supports regulatory documentation, post-approval changes, scale-up, and assessment of contract manufacturing and development work. Work takes place in a typical office environment and a laboratory setting, with possible exposure to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Requirements

Broad experience in pharmaceutical development: 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.
Knowledge of analytical, formulation, and process-development techniques, including troubleshooting, process optimization, and scale-up.
Demonstrated technical leadership in complex problems requiring in-depth evaluation of multiple factors.
Ability to lead and conduct technical investigations with minimal supervision.
Excellent oral and written communication skills, demonstrated through internal and external interactions.
Knowledge of ICH, SUPAC, and cGMP guidelines.

Responsibilities

Direct atypical and scientifically complex research and serve as a recognized thought leader throughout the company.
Perform process and formulation optimization for commercial product lines to achieve financial goals for product improvement activities.
Design and execute investigations to determine root causes.
Complete CAPA and corrective processes as needed throughout the company.
Prepare scientific documentation describing and supporting process changes and improvements for regulatory submissions.
Support designated process-improvement projects involving formulations, optimization, and scale-up.
Provide broad technical direction as a company resource.
Review the work of less experienced employees and resolve problems.
Make scientific recommendations to management regarding the acceptability and quality of affected product lots.
Oversee generation and compilation of technical data required to support post-approval changes.
Assess technical feasibility and serve as a technical liaison for incoming contract manufacturing and development work.
Participate in required annual hazardous-waste training and related hazardous-waste management activities, including container and tank management and inspections, hazardous-waste generation, and waste transfers.
Respond to spills in accordance with Chemical Spill Procedures.
Perform other duties as assigned.