Scientist I

Allergan; Waltham (MA); On-site; USD 120,000 - 180,000; Full time

Job summary

AbbVie is seeking an experienced professional to support tech transfer of ADC drug substance programs to manufacturing sites, including floor support and batch record review. The role includes laboratory work for late-phase characterization and optimization.

You will design experiments, implement new protocols, and maintain program proficiency, serving as PIP during critical unit operations and ensuring GxP compliance across the project.

Qualifications

• Bachelor’s Degree or equivalent education with typically 5 years of experience.
• Theoretical and practical knowledge to carry out the job functions.
• Master’s degree or equivalent with typically two years of experience is a plus.

Responsibilities

• Independently design and conduct critical experiments that further project goals.
• Draft change control proposals and deviation impact assessments.
• Draft process validation protocols and reports including PPQ protocol and master plan.
• Review manufacturing batch records and support feasibility of process changes.
• Perform routine and complex tasks and generate reliable results.
• Support manufacturing studies such as mixing validation and deviation investigations.

Skills

Process development

Laboratory skills

cGMP knowledge

Change controls

Batch record review

HPLCs

Cross-functional collaboration

Education

Bachelor's degree in science

Master’s degree in science

Tools

LIMS

SAP

AVEVA PI Vision

Job description

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 at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.

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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: https://www.abbvie.com/join-us/reasonable-accommodations.html