Purpose and ScopeConsidered 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. Hazardous waste involvement may include, but is not limited to container and tank management and inspections, generation of hazardous waste as a part of production or sampling processes 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.
Compensation and Benefits- Pay: $145,000.00 to $154,000.00
- Bonus eligible
- Benefits summary: https://www.tolmar.com/careers/employee-benefits
Tolmar compensation programs are focused on equitable, fair pay practices including market-based base pay and a strong benefits package. The final compensation offered may vary from the posted range based on the selected candidates qualifications and experience.
