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. 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.
Core Values
This position is expected to operate within the framework of Tolmar’s Core Values:
- Center on People: We commit to support the well‑being of our patients and treat our employees and those we serve as valued partners. By placing people at the heart of our actions, we actively engage, invigorate, acquire knowledge, and grow together with an enterprise‑wide mindset that lifts the whole organization.
- Are Proactive & Agile: We embody a culture of engagement and action. With a hands-on approach, we fearlessly adapt to change. We anticipate, respond swiftly and efficiently to ignite a spirit that propels us towards extraordinary outcomes.
- Act Ethically: We are committed to consistently conducting our business in an ethical, compliant, and socially aware manner, in line with our purpose of positively impacting lives. We actively cultivate diversity, equity, inclusion & sustainability in our workplace.
- Constantly Improve: We are committed to a proactive, collaborative effort to enhance our products, systems, processes, and services by reducing waste, increasing efficiency, and improving quality. We strive to be innovative, embracing calculated risk‑taking that drives better ways of working.
- Are Accountable: We think, act, and communicate with honesty, transparency, and clarity in alignment with our core values. We don't compromise our values for near term gain. We take accountability & ownership of our work, actions, successes, and setbacks. We strive to deliver our best as we shape the future.
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
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.
Tolmar is an Equal Opportunity Employer. We do not discriminate on the basis age 40 and over, color, disability, gender identity, genetic information, military or veteran status, national origin, race, religion, sex, sexual orientation or any other applicable status protected by state or local law. It is our intention that all qualified applicants be given equal opportunity and that selection decisions are based on job-related factors.