Scientist II, Sample Management- Quantitative, Translational and ADME Sciences

Company Description

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 immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

The Quantitative, Translational and ADME Sciences (QTAS) department at AbbVie Bay Area located in South San Francisco is looking for ahighly proactive Sample Management Sr. Scientist. The Senior Scientist in Biomarker Sample Management and Compliance will oversee the management of biomarker samples and ensure compliance with clinical and non-clinical biospecimen utilization. This role involves collaboration with various teams to ensure adherence to protocol language and informed consent processes for clinical study, focusing on biomarker specimen management, compliance, and execution of specimen transfers and study close-out activities.

Responsibilities

• Sample Management Ensure Operations team are executing following the SOP the sample receipt, storage, destruction, and transfer of samples to internal and external stakeholders. Act as the point of contact for biomarker clinical sample management. Responsible for study setup and accurately logging samples into the laboratory LIMS system based on defined timelines and standards. Ensure all sample collections, storage, and transfers follow protocols, regulatory requirements (ICH/GCP/GLP), ICF status, and project timelines. Liaise with scientists, sites study team, vendors, and/or CRO to resolve queries, discrepancy and reconciliation in a timely manner. Partner with Biomarker leads to ensure the delivery of samples is in accordance with study timeline.
• Supply Management Responsible for contracting labeling of critical assay reagents, receipt, storage, and transfer of reagents to internal and external stakeholders.
• Sample Processing Support the processing of biological samples to facilitate subsequent bioanalysis. Ensure that reconciliation is achieved to deliver assay-ready samples to testing teams.
• Laboratory Management Assist in laboratory oversight of cleanliness, maintenance, and safety procedures. Support the routine and non-routine maintenance of laboratory equipment. Responsible for procurement of laboratory equipment.
• Data Management Coordinate assay results data transfer to stakeholders database. Able to organize and manage large data sets and provide regular summaries to team.
• Compliance Ensures sample collection, delivery, receipt, analysis, and disposition of biological samples under the highest standards of quality, ethics, compliance, and in accordance with informed consent. Conduct sample and assay reagent supply receipt and shipping activities in accordance with IATA, FDA, US Fish & Wildlife Service, CDC, USDA or other relevant international regulations.
• SOPs Establish in-depth knowledge and creation of relevant SOPs and contribute to their periodic review maintenance. Contribute to functional processes and system improvements and implementation to ensure samples are collected, processed, and analyzed appropriately. Support the development of job aids and other process documents.
  
  
  

Qualifications

• Bachelors degreein life sciences field or equivalent combination of education and experience.
• 7 or more years of relatedexperience for BA/BS or 5or more years of related experience for MS/MA.
  
  
  

Preferred, But Not Required

• Sample Management experience, preferably clinical trial specimens
• Expertise in LIMS Systems for sample handling and tracking storage
• Excellent interpersonal, communication, and presentation skills, interfacing with departments and external partners.
• Excellent organizational skills, ability to handle multiple tasks, and detail oriented able to accurately interpret and transcribe information from a client chain of custody into the laboratory LIMS system
• Ability to function effectively in a high-paced and at times stressful environment to meet deadlines
• Strong computer literacy skills and proficiency in Microsoft Office Suite
• Strong project planning, problem solving and decision-making skills. Experience working with project management and/or inventory management systems
• Experience working in a regulated, quality environment is a plus
• Able to lift 25-40 lbs.
  
  
  

Key Leadership Competencies

• Builds a strong relationship with peers and cross functionally with partners outside of team to enable higher performance.
• Learns fast, grasps the "essence, and can change course quickly where indicated.
• Raises the bar and is never satisfied with the status quo.
• Creates a learning environment, open to suggestions and experimentation for improvement.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
  
  
  

Additional Information

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

• The compensation range described below is the range of possible base pay compensation that the Company believes ingood faith it will pay for this role at the time of this posting based on the job grade for this position. Individualcompensation paid within this range will depend on many factors including geographic location, and we may ultimatelypay 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/visioninsurance and 401(k) to eligible employees.
• This job is eligible to participate in our short-term incentive programs.
  
  
  

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, and determinable.The amount and availability of any bonus, commission, incentive, benefits, or any other form of compensation and benefitsthat are allocable to a particular employee remains in the Company's sole and absolute discretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent with applicable law.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.

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