AbbVie

Manufacturing Associate II - New Production Introduction

Employer
AbbVie
Location
Worcester, MA, United States
Posted
Feb 25, 2021
Ref
2102629
Required Education
Associate Degree
Position Type
Full time
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 .

Purpose:

The Manufacturing Associate, New Product Introduction (NPI) will support New Product Introductions and program manufacturing readiness and will be part of the Business Unit 3 team. A key support for production activities in manufacturing, the Manufacturing Associate II will be responsible for batch record post-review and relevant metrics, development modification and CAPA implementation/processing. The Manufacturing Associate will interact frequently with customers in many functional areas including Process Sciences, Protein Analytics, Manufacturing Sciences, Manufacturing, Tech Transfer, Quality, and Engineering to help support new product introduction for clinical and commercial programs.

Responsibilities:
  • Primary manufacturing batch record review post-campaign for manufacturing batches.
  • With direction, supports the transfer of products and processes into manufacturing. May provides feedback to Tech Transfer for batch records, performs on the floor review with manufacturing technicians, and assists with process fit into the manufacturing facility. Supports area documentation and administrative needs for manufacturing readiness.
  • Works closely with cross functional team on the process development, batch record development, technical transfer, process fit/scale-up of new product introductions.
  • Measures success through metrics and supports continuous improvement to improve agility for NPI.
  • Supports the completion of programs and projects.
  • Applies knowledge, experience, and technical skills to understand specific site objectives, so proved support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Works, within established systems to improve Good Manufacturing Practices, GMP) compliance.
  • Coordinates activities of subgroup and actively works under other sub-groups. Provides technical direction and training to less senior personnel.
  • Works on problems of moderate complexity, where analysis of situations requires evaluation of several factors.
  • Works under general supervision. Follows established procedures. Decisions are reviewed for soundness of technical judgement.

Qualifications

Qualifications:

  • Bachelor's Degree or equivalent is preferred.
  • At least 2 years' experience in aspects of manufacturing and production processes.
  • Knowledge of media and buffer preparation, cell culture, and purification of biological drugs is preferred.
  • Familiar with and continuous improvement of, tech transfer process; Adeptness with equipment, facilities validation, and regulatory policies.
  • Proficient with Microsoft Office (Outlook, Excel, Word, and PowerPoint).
  • A working knowledge of safety, quality systems and Good Manufacturing Practices required.
  • Must be flexible to handle multiple tasks including ability to handle pressure in a professional and positive manner; Effectively works in a team environment; Maintains high level of energy and professionalism on the job; Build effective working relationships with customers, co-workers, cross-functioned groups, and management; Proactively and effectively participates in the continuous improvement process.
  • Frequently interacts with functional peer groups at various management levels. Interaction normally requires the ability to gain cooperation of others. Regularly discusses progress, problems, and proposed solutions with colleagues and senior personnel.
  • Provides a motivational and team building atmosphere.

Significant Work Activities
N/A
Travel
No
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.