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Tech Transfer Documentation Author

Employer
AbbVie
Location
Worcester, Massachusetts
Start date
Sep 20, 2022
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Job Details

  • Transfers methods into Production instructions to allow for successful performance of scheduled campaigns.
  • Schedules work tasks, with limited assistance, to support project/campaign timelines. Drafts diverse scope and complexity documents. Circulates documents to reviewers with limited assistance, responds to comments and questions. Manages document review and approval to meet project timelines.
  • Directs changeover activities with assistance.
  • Exercises judgment within generally defined procedures and practices to determine appropriate action. Tracks ongoing problems and gathers information for analysis. Analyze data to develop solutions to general-level problems. Presents a potential solution to management/senior personnel and with assistance creates an implementation plan.
  • Applies knowledge, experience and technical skills to understand ABC Production objectives, to provide support to Production initiatives, to execute systems and procedures efficiently and compliantly, evaluates systems for improvement potential. Use standard practices to ensure inter-group consistency. Works, within established systems to improve Good Manufacturing Practices (GMP) compliance.
  • 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 judgment.
  • Coordinates activities of sub group and actively works under other sub-groups. Provides technical direction and training to less senior personnel.
  • Frequently interacts with subordinates and functional peer groups. Interaction normally requires the ability to gain cooperation of others, conducting presentations of technical information concerning specific projects, schedules, etc.

  • Bachelor’s Degree or equivalent required.
  • At least 5 years’ experience in all aspects of manufacturing/production processes with good writing skills.
  • Knowledge of media/buffer preparation, cell culture or purification of biological drugs is required.
  • Computer and scheduling proficiency.
  • A working knowledge of safety, quality systems, and current Good Manufacturing Practices as applied to equipment and process steps in area of responsibility is required. Familiarity with pertinent regulatory filings. Proficiency with tech transfer process and familiarity with equipment and facilities validation.
  • Must be flexible to handle multiple tasks including ability to handle pressure in a professional manner. Effectively work in a team environment. Maintain high level of energy and professionalism on the job. Build effective working relationships with customers, co-workers, cross-functioned groups, and management.

At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity and affirmative action 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. If you would like to view a copy of the company’s affirmative action plan or policy statement, please email CorpJat_ABV@abbvie.com.


Company

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, and YouTube.

Stock Symbol: ABBV

Stock Exchange: NYSE

Find Us
Website
Phone
1-800-255-5162
Location
1 North Waukegan Road
North Chicago
Illinois
60064
United States
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