Scientist I
AbbVie
August 31, 2026
On-site
Waltham, MA
$75,000 - $142,500 USD yearly
Clinical Research and Development
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, and serving as SME for ADC manufacturing suite equipment and capabilities. Includes some laboratory work for late-phase process characterization and optimization.
Responsibilities:
- Independently design and conduct critical experiments; implement and may innovate experimental protocols/techniques.
- Maintain proficiency in projects and the overall program; serve as PIP during critical unit operations.
- Review manufacturing batch records.
- Draft change control proposals and deviation impact assessments.
- Draft process validation protocols and reports (PPQ protocol, process justification reports, process validation master plan).
- Interpret results and draw conclusions; note deviations and design/pursue relevant experiments.
- Apply scientific literature and theoretical frameworks to solve problems.
- Perform routine and complex tasks independently with reliable results.
- Ensure compliance with corporate/divisional policies and GxP/safety/material handling standards.
- Design/execute experiments for process characterization/optimization (including chemical stability).
- Support manufacturing studies (e.g., mixing validation, deviation investigations) and participate in risk assessments (process FMEAs).
Qualifications:
- Bachelor’s degree (typically 5 years experience) or Master’s degree (typically 2 years experience) plus theoretical and practical knowledge.
Preferred Qualifications:
- Scientific/engineering degree (plus).
- Hands-on lab and/or manufacturing experience as PIP/manufacturing operator (preferred).
- Knowledge of stainless steel or single-use mAb production; ADC conjugation, UFDF, and column chromatography (plus).
- cGMP, process characterization/validation experience.
- Travel to Worcester and Waltham, MA (occasional).
- Experience with electronic notebooks, LIMS, SAP, AVEVA PI Vision; change controls/deviations; cross-functional teams.
- Experience with analytical instruments such as HPLCs.
Responsibilities:
- Independently design and conduct critical experiments; implement and may innovate experimental protocols/techniques.
- Maintain proficiency in projects and the overall program; serve as PIP during critical unit operations.
- Review manufacturing batch records.
- Draft change control proposals and deviation impact assessments.
- Draft process validation protocols and reports (PPQ protocol, process justification reports, process validation master plan).
- Interpret results and draw conclusions; note deviations and design/pursue relevant experiments.
- Apply scientific literature and theoretical frameworks to solve problems.
- Perform routine and complex tasks independently with reliable results.
- Ensure compliance with corporate/divisional policies and GxP/safety/material handling standards.
- Design/execute experiments for process characterization/optimization (including chemical stability).
- Support manufacturing studies (e.g., mixing validation, deviation investigations) and participate in risk assessments (process FMEAs).
Qualifications:
- Bachelor’s degree (typically 5 years experience) or Master’s degree (typically 2 years experience) plus theoretical and practical knowledge.
Preferred Qualifications:
- Scientific/engineering degree (plus).
- Hands-on lab and/or manufacturing experience as PIP/manufacturing operator (preferred).
- Knowledge of stainless steel or single-use mAb production; ADC conjugation, UFDF, and column chromatography (plus).
- cGMP, process characterization/validation experience.
- Travel to Worcester and Waltham, MA (occasional).
- Experience with electronic notebooks, LIMS, SAP, AVEVA PI Vision; change controls/deviations; cross-functional teams.
- Experience with analytical instruments such as HPLCs.