Manager MS&T

Purpose and Scope

Manage a team responsible for commercial product support initiatives in product technical transfers, process improvement, optimization, troubleshooting and investigation support while ensuring compliance with Tolmar's GMP, SOP's, FDA, EH&S and DEA Guidelines. Supports the commercial manufacturing operation in problem-solving with regard to processes, equipment and systems.

Essential Duties & Responsibilities

• Develop and lead work plans, project teams and provide technical direction for product transfer activities.
• Define and manage the scope of projects and ensure projects align with Product Development decisions and strategies.
• Acts as product owner for commercial products, creating lifecycle management plans, leading projects, and serves as technical expert for the commercial product.
• Manage and resolve technically orientated investigations related to product transfer initiatives.
• Define plans and timelines for implementation plans, evaluating and enhancing process optimization and process improvements initiatives that will include process yield, product throughput timing and trending for quality analysis.
• Leads teams to develop and improve related business processes and tools.
• Ensure that MS&T operations and functions within their scope are in full FDA, cGMP, OSHA and DEA regulatory compliance, and employees are trained.
• Responsible for meeting group objectives while managing spending, capital and labor to budget.
• Communicate openly to provide and gather information, optimize the use of resources and optimize efficiency.
• Ensures compliance with all Safety Guidelines and Company Procedures.
• 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.
• Ensures compliance with all Safety Guidelines and Company Procedures.
• Perform various other duties as assigned.

Knowledge, Skills & Abilities

• 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.
• Effective skill in troubleshooting, process optimization and scale-up.
• Excellent oral and written communication skills demonstrated through interactions internally and externally.
• Knowledge of ICH, SUPAC, and cGMP Guidelines
• Strong knowledge of pharmaceutical manufacturing processes and systems.
• Knowledge of FDA guidelines and cGMP Procedures.
• Excellent written and verbal communication and interpersonal skills.
• High attention to detail and personal responsibility.
• Ability to manage multiple projects and prioritize/reprioritize work.

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. We are committed to treating 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.
• 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 collaborative & proactive effort to improve our products, systems, processes, and services by reducing waste, increasing efficiency & improving quality.
• 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

• Bachelor's Degree in Chemistry, Biology, Engineering, or equivalent field preferred.
• Seven or more year's experience in the pharmaceutical industry. Four or more years of experience in technical support or manufacturing roles preferred.

Working Conditions

• Working conditions are in an office, laboratory and manufacturing environment. Work may require occasional weekend and/or evening work and some travel may be required.

Compensation and Benefits

• Annual pay range $130,000 - $135,000
• Bonus eligible
• Benefits information: 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.

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.