Technical Services Scientist III

Purpose and Scope

The person is responsible for providing extensive scientific support for the QA / QC, regulatory, manufacturing, and development groups.

Essential Duties & Responsibilities

• Responsible for process and formulation optimization of commercial product lines to achieve financial goals of product improvement activities.
• Prepare scientific documentation describing and supporting process changes and improvements for regulatory submissions.
• Lead process improvement efforts with designated projects.
• Lead investigation efforts for product deviations and perform root cause analysis.
• Serve as a company resource, providing technical direction.
• Make scientific recommendations to management as to the acceptability and quality of affected product lots.
• Participate in the generation and lead the 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 development / commercial project timeline meetings and lead efforts for designated products.
• Mentor less experienced members of the team.
• Demonstrate independent thinking attributes and show initiative on project implementation.
• Understand and provide a global perspective of product regulations.
• Participates 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

• Solid knowledge of analytical, formulation, and process development techniques encompassing skills associated with troubleshooting, process optimization, statistical analysis, and scale-up.
• Demonstrated proficiency with RCA, technical assessments, scientific creativity, and collaboration with other functional area.
• Strong working knowledge of different drug product types, including semi-solids.
• Demonstrated experience in technical writing as evidenced by scientific publications, presentations, etc.
• Solid knowledge of ICH, SUPAC, and cGMP Guidelines.
• Knowledge of pharmacokinetic and pharmacodynamic principles.
• Good computer and data analysis skills (word processing, spreadsheets, database searching, statistics, etc.)
• Excellent organization skills, data collection, etc.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.

Core Values

• The Technical Services Scientist III is expected to operate within the framework of Tolmar’s Core Values :
• Consistently operate with the highest standards of ethics and compliance.
• Take ownership of your actions, success and setbacks.
• Respect each other and understand that honest collaboration is at the heart of our company's success.
• Go the extra mile to make things happen.
• Be committed to all we do and the patients we serve.
• Embrace change with enthusiasm.
• Strive to learn about and understand the needs of customers and patients, and take action with great speed and efficiency no matter the task.

Education & Experience

• Bachelors of Science in Chemistry or related field.
• Seven or more years’ experience in a pharmaceutical lab or manufacturing.

Working Conditions

Laboratory and manufacturing setting. Will be exposed to solvents, bio-hazardous materials, hazardous waste, and pharmaceuticals.

Compensation and Benefits

• Pay range : $115,000 - $130,000
• Bonus Eligible
• Relocation benefits available
30+ days ago