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Associate Director, Technical Operations
Company: Abbvie
Location: Campbell, CA
Employment Type: Full Time
Date Posted: 10/02/2021
Expire Date: 03/16/2022
Job Categories: Accounting/Auditing, Biotechnology and Pharmaceutical, Customer Service and Call Center, Healthcare, Practitioner and Technician, Information Technology, Internet/E-Commerce, Manufacturing and Production, Executive Management, Medical, Web Technology, Writing/Authoring
Job Description
Associate Director, Technical Operations
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.

The AD, Technical Operations can be based out of Campbell, CA or Irvine, CA.

Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix, leading discussions, asking the right questions, and driving results. 

 

WHAT YOUR NEW MANAGER WANTS YOU TO KNOW:

We are looking for a technical operations leader for our potent biologics sites.  The specifics of the position will be commensurate on experience and may encompass a technical SME role and/or managerial position with a small team.  The role supports operations at both Campbell, CA and Irvine, CA so travel between the two sites would be required.  Experience with GMP manufacturing, CMC filing support, process validation, analytical methods, scale-down lab studies and process characterization are all key. 

 

You are more than just a title, you are responsible for manufacturing support of biologics processes with a focus on fermentation, purification, and equipment in clean room environments with biosafety classifications.  Provides rapid response to operational issues and supports ongoing operations including process monitoring, process knowledge management, cleaning and maintaining full compliance with GMP regulations.  Interacts with manufacturing personnel and provides on-the-floor support of cGMP operations.  Partner with site teams and global Science and Technology teams for improving process understanding and driving changes.

 

Responsibilities:

  • Responsible for biologics manufacturing process technical support and improvement initiatives for ongoing operations.
  • Supports manufacturing activities during the technology transfer, qualification and validation batches associated with new product introductions to the site.  Primary focus is commercial product support.
  • Supports operational efficiency goals for yield, product quality and site KPI’s
  • Leadership for process/equipment troubleshooting and investigation activities.
  • Actively promotes a culture of GMP and EHS compliance with all applicable policies and guidelines and supports risk assessment activities providing relevant technical knowledge.
  • Provides support to regulatory filings and audit activities
  • Authors technical reports, batch records, SOP’s, investigations ad protocols as required and ensures consistency and quality of documentation.
  • Any other duties assigned by supervisor.

Qualifications

 

  • Minimum of 5 years experience and a bachelor’s degree with 10-15 years experience preferred in a pharmaceutical manufacturing environment depending on degree.
  • BS, MS or PhD in scientific or engineering discipline.  Target fields include chemical/biochemical engineering or related technical/science field encompassing biotechnology such as microbiology, biochemistry etc.
  • Ability to successfully manage multiple projects and programs.
  • Experience with Select Agents and biosafety is a plus.
  • Knowledge of cGMP and regulatory requirements relating to the biopharmaceutical industry.
  • Technical experience with bioreactors, CIP/SIP, column chromatography, UF/DF, filtration technologies and single-use systems all desirable.
  • Experience with new product introduction and commercial facilities/products.
  • Good problem-solving skills and use of tools like FMEA, 5 Why’s with the ability to work under pressure and deliver on tight timelines.
  • Team player, highly self-motivated and able to work under minimum supervision.
  • Good command in oral and technical writing in English, and excellent communication and presentation skills.
  • Ability to actively listen, build and maintain effective working relationships with internal/ external colleagues and stakeholders, and resolve conflict.

 

For this role, we’re looking for an engineering leader who is:

  • Attention to detail, focused
  • Technical SME on biologics bulk drug substance operations and processes
  • Quality Focused
  • Acts as an Owner

Significant Work Activities
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.
Contact Information
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