Scientist I

ABBVIE; Waltham (MA); On-site; USD 75,000 - 143,000; Full time

Job summary

AbbVie in the United States (Waltham/Worcester area) seeks a qualified scientist to support the tech transfer of ADC drug substance programs to manufacturing sites. The role includes bench work, batch record review, deviations, and validation documentation to ensure successful production transfer.

Responsibilities cover designing experiments, drafting change controls, and validating processes, with emphasis on GMP compliance and cross-functional collaboration.

Qualifications

• Bachelor’s or Master’s degree with related experience.
• Theoretical and practical knowledge to perform job functions.
• Willingness to travel to Worcester and Waltham, MA.

Responsibilities

• Independently design and conduct critical experiments for project goals.
• Review manufacturing batch records and assess deviations.
• Draft change controls and deviation impact assessments.
• Draft process validation protocols and reports (PPQ, MVP, etc.).
• Support lab work for process characterization and optimization.
• Ensure compliance with cGMP, safety, and data integrity standards.

Skills

Theoretical & practical knowledge

Education

Bachelor's Degree (or equivalent)

Master's Degree (or equivalent)

Tools

Electronic notebooks

LIMS

SAP

AVEVA PI Vision

Job description

• Compensation: USD 75000 - USD 142500 - yearly

Company Description

About AbbVie

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com . Follow @abbvie onLinkedIn, Facebook ,Instagram ,X andYouTube.

Job Description

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

Qualifications

• 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.

Preferred Qualifications:

• 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

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

This job is eligible toparticipate in our short-term incentiveprograms.

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.Theamountandavailabilityof anybonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employeeremains in the Company'ssoleandabsolutediscretion unless and until paid andmay bemodified at the Company’s sole and absolute discretion, consistent withapplicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.