Support tech transfer of ADC drug substance programs to manufacturing sites including person-in-plant floor support, batch record review, deviation impact assessments, change controls, validation documentation, become SME for ADC manufacturing suite equipment and capabilities. This role will also involve some laboratory work for late phase process characterization and optimization.
Responsibilities:
- Independently design and conduct critical experiments that further project goals.
- Implement and may innovate new experimental protocols/techniques.
- Understand the goal and maintain a high proficiency in his/her projects as well as the overall program.
- Serve as PIP during critical unit operations of manufacturing runs
- Review manufacturing batch records
- Draft change control proposals and deviation impact assessments
- Draft process validation protocols and reports including PPQ protocol, process justification reports, process validation master plan
- Interpret results and draw conclusions from own multistage experiments, note significant deviations, then suggest, design, and pursue relevant experiments.
- Understand relevant scientific literature and apply theoretical framework to solving problems within scientific discipline in a timely manner.
- Perform routine and complex tasks competently and independently and generate reliable and consistent results.
- Responsible for compliance with all applicable Corporate and Divisional policies and procedures.
- Understand and adhere to corporate standards regarding code of conduct, safety, appropriate handling of materials, controlled drug and radioactive compounds, GxP compliance, and animal care where applicable
- Design and independently execute experiments for process characterization or optimization including chemical stability studies
- Support manufacturing studies as needed such as mixing validation studies or deviation investigation studies
- Participate in risk assessments including process FMEAs