Purpose and Scope
Performs the design and implementation of aseptic manufacturing processes, instrumentation, and equipment for product technical transfer to commercial manufacturing scale-up. Provides support for existing commercial products/processes when needed. Develops and recommends new process technologies to achieve improved product quality and cost effectiveness.
Essential Duties & Responsibilities
- Collaborate with the formulation team to develop and improve manufacturing processes for new and existing products.
- Conduct process research and develop robust manufacturing processes for bulking, cleaning, and filling of new sterile products.
- Interface with equipment vendors to specify equipment, request quotes and order equipment.
- Write protocols, reports, batch records, procedures, and other controlled documentation.
- Develop and perform process validation and write validation reports.
- Develop cleaning processes and perform cleaning validation.
- Provide hands-on execution of engineering studies and manufacture of clinical trial batches.
- Understand cGMP requirements and collaborate with Quality Assurance, Validation and Regulatory to ensure compliance.
- Experience with Quality-by-Design (QbD) utilizing Design of Experiments (DoE); development of Risk Assessments and Critical Process Parameters (CPPs).
- Provide technical training to manufacturing employees.
- 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 pharmaceutical manufacturing processes and systems.
- Experience with aseptic processing practices and thorough knowledge of requirements for working in aseptic manufacturing environments.
- Knowledge of FDA guidelines and cGMP requirements.
- Excellent professional written and verbal communication and interpersonal skills.
- High attention to detail and sense of personal responsibility.
- Ability to manage multiple projects and prioritize/reprioritize work.
- Ability to work independently with minimal supervision as well as cooperatively on a team.
- Excellent ability to analyze complex development problems and provide creative solutions.
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
- Bachelor’s degree in chemical engineering or other scientific discipline plus equivalent engineering experience.
- Three or more years’ experience in Product and/or Process Development in the Pharmaceutical/Biotech industry.
Working Conditions
- Working conditions are in an office, laboratory and manufacturing environment.
- Work may require occasional weekend and/or evening work.
- Work may require lifting objects up to 25 lbs. and use of a respirator.
Compensation and Benefits
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.
