Senior Scientist - MEC Laboratory

About AbbVie
AbbVie's mission is to discover and deliver innovative medicines 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, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter , Facebook , Instagram , YouTube and LinkedIn .

Description - External

Job Summary

The MEC Senior Scientist works to resolve any laboratory issues that need to be addressed to support QC MEC laboratory operations, either in the environmental, or testing area. Will coordinate to implement new methods and systems. Provides Technical Support in all microbiological events and performs the microbiological assessment of all events related to product testing, utilities testing or environmental monitoring that potentially impacts the product quality. The end result is directed towards troubleshooting, improvement, assurance of product quality, and resolution of process and quality issues in both SVP and BDS areas.

Major Responsibilities

• Performs MEC investigations involving environmental failures, in process and product testing, and utilities failures. Designs experiments and writes technical reports according to standard operational procedures.
• Lead the troubleshooting efforts in manufacturing related to any environmental, utilities or product event and ensure completion of investigation process. Lead investigations for these events.
• Participates in technology transfer, validation projects, method development or modifications.
• Performs troubleshooting for MEC testing (LAL, Identification, Sterility Testing, Bioburden, TOC and Conductivity) and environmental monitoring. Performs cal alert investigations, annual reviews, and data trending evaluation.
• Provides technical support, establishes ownership; assures product quality and compliance in the biologics manufacturing operations (SVP and BDS).
• Responsible to comply with AbbVie Corporate and Global Quality Operations (GPO) policies, ABL plant procedures, and Food and Drug Administration (FDA) cGMP regulations and requirements.
• Interacts efficiently with colleagues in other areas, such as Technical Operations, Analytical Laboratory, Manufacturing, and MEC Laboratory at Abbott Bioresearch Center in Worcester, MA.
• Responsible for the preparation of SVP monthly reports, trend reports, contamination recovery percentage evaluation/reports, BDS and SVP quarterly reports and gowning reports.
• Interacts with auditors during regulatory or corporate audits.
• Will supervise product related MEC group in the absence of the MEC Lab Senior Supervisor.

Position Accountability

Responsible of developing/reviewing assay procedures used to certify product quality, recommend technological changes or improvements that might affect product testing cost. Responsible to assess microbiological events and determine the impact to product quality.

Qualifications

Educational Requirements

• Master Degree in Microbiology, required.

Experience Requirements

• At least 3 years of experience in a Microbiological Laboratory, required.
• Must have experience in a biological manufacturing environment.
• Strong background in microbiological laboratory testing such as: LAL, Sterility, Identification systems, bioburden, among others.
• Strong Technical Writing abilities, required.

Total combined experience: 8 years

Significant Work Activities
Continuous walking for prolonged periods (more than 2 hours at a time in an 8 hour day)
Continuous standing for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Travel
Yes, 5 % of the Time
Job Type
Experienced
Schedule
Full-time
Job Level Code
IC
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.