Sr Technical Services Scientist (On-Site)

Tolmar•Windsor, CO

2d•$145,000 - $154,000•Onsite

About The Position

The Sr Technical Services Scientist is a technical leader with a specialized focus on product, process, and quality improvement initiatives across all product lines. The role provides scientific support to QA/QC, regulatory, manufacturing, and development groups, and leads investigations, root-cause determination, and Corrective Action and Preventative Action (CAPA) activities. This position directs complex scientific research, optimizes commercial product formulations and processes, supports process improvement and scale-up projects, and prepares scientific documentation for regulatory submissions and post-approval changes. It also provides technical direction across the company, reviews less experienced employees’ work, advises management on affected product lot quality, and serves as a technical liaison for contract manufacturing and development work. The role includes participation in annual hazardous-waste training and related waste management, inspections, handling, transfers, and spill response. Working conditions include 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: more than 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 principles associated with analytical, formulation, and process development techniques, including troubleshooting, process optimization, and scale-up.
Demonstrated technical leadership on 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 thought leader throughout the company.
Perform process and formulation optimization for commercial product lines to support financial goals for product improvement activities.
Design and execute investigations that 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 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 act as a technical liaison for incoming contract manufacturing and development work.
Participate in required annual hazardous-waste training and related container and tank management, inspections, hazardous-waste generation and transfers, and spill response under Chemical Spill Procedures.
Perform other duties as assigned.