Scientist, Quality Engineering, Process Engineer

Job Title

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.

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.

Bachelor's Degree or equivalent education with typically 5 years of experience, or Master's Degree or equivalent education with typically two years of experience. Theoretical and practical knowledge to carry out the job functions.

Degree in a scientific or engineering discipline (chemical engineering, biomedical engineering, biology, chemistry, biotechnology, etc) is a plus. Hands on laboratory experience and/or manufacturing experience as PIP or manufacturing operator is preferred, but not required. Experience or working knowledge of stainless steel or single-use mAb production processes. ADC conjugation processes, UFDF, and column chromatography experience is a plus. Knowledge of cGMP principles.

Experience with process characterization and process validation. Applicant must be able to travel to Worcester and Waltham, MA. Occasional travel may be required. Experience working with electronic notebooks, LIMS, SAP, and real time monitoring software such as AVEVA PI Vision. Experience supporting change controls and deviations. Experience working cross functionally on project teams. Experience working with analytical instruments such as HPLCs.

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range.

This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees. This job is eligible to participate in our short-term incentive programs.

Pay Range: $75000 - 142500 USD