Senior Scientific Services Leader – Process & Quality

Tolmar; Windsor (CO); On-site; USD 145,000 - 154,000; Full time

Benefits offered by this job

Bonus eligible

Benefits package

Job summary

Tolmar seeks a technical leader in pharmaceutical development to provide scientific support for QA/QC, regulatory, manufacturing and development groups. You will lead investigations, determine root causes, and participate in CAPA processes while driving process and formulation optimization for commercial products.

The role includes preparing regulatory documents, guiding process improvements, and serving as a technical resource across teams.

Qualifications

• Proven ability to lead complex analytical and formulation development.
• Strong investigative skills with root-cause analysis.
• Experience with CAPA processes and regulatory documentation.
• Excellent oral and written communication; cross-functional collaboration.
• Knowledge of ICH, SUPAC and cGMP guidelines.

Responsibilities

• Lead atypical and scientifically complex research across product lines.
• Direct investigations and determine root causes to support CAPA.
• Prepare technical documentation for regulatory submissions.
• Oversee data generation to support post-approval changes.
• Provide technical direction and mentorship to staff.

Skills

Analytical formulation development

Technical leadership

Investigation leadership

Excellent communication

ICH, SUPAC & cGMP knowledge

Education

Bachelor of Science degree

Master's degree

PhD

Job description

Tolmar seeks a technical leader in pharmaceutical development to provide scientific support for QA/QC, regulatory, manufacturing and development groups. You will lead investigations, determine root causes, and participate in CAPA processes while driving process and formulation optimization for commercial products.

The role includes preparing regulatory documents, guiding process improvements, and serving as a technical resource across teams.