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Manufacturing Manager

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Date: Jun 8, 2021

Location: San Diego, CA, US

Company: Wacker Chemie AG

 

 

Our world needs ideas! As one of the world’s most research-intensive chemical companies, Wacker has been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and 13,800 employees from 70 nations.

 

Wacker Biotech, as part of Wacker, is a leading global biotechnology organization specializing in the production of biopharmaceuticals. The company has outstanding technologies for the rapid, efficient and thus cost-effective production of therapeutic proteins for clinical and commercial supply. Currently it is the biggest dedicated microbial Contract Development & Manufacturing Organization (CDMO) in the world. Its four dedicated and fast-growing production sites are currently based in Germany (Halle and Jena), The Netherlands (Amsterdam) and The United States (San Diego, CA).

 

Our regional presence in the U.S. is focused on GMP-compliant manufacturing of plasmid DNA products up to 500L. The team has extensive experience up to phase III clinical supply and successfully released more than 100 GMP batches for advanced therapy applications. 


At our San Diego site, we are currently looking for a  ​Manufacturing Manager​ to be a part of our growing team.

 

 

Job Responsibilities

 

Wacker Biotech is looking for a Manufacturing Manager to manage and assist in upstream and downstream production activities in a cGMP manufacturing environment. The position reports to the Director of Manufacturing and is responsible for all aspects of plasmid manufacturing operations.

This position will be responsible for:

  • Experience creating production scheduled and technical project schedules and achieving manufacturing deadlines and budgets in cGMP environment.
  • Perform tech transfer process from process development to manufacturing scale.
  • Manage and assist in multiple unit operations such as microbial fermentation, large-scale buffer prep, and downstream recovery operations such as cell lysis and chromatography as well as daily upkeep of the plant.
  • Meet manufacturing objectives, either directly or through subordinate staff, to perform cleaning validation on process equipment, and process validation to cGMP and SOP standards.
  • Generate validation protocols and summarize results in technical reports.
  • Write Quality Systems investigation reports, manage operator training, and participate in plant inspections.
  • Manage generation and review of GMP documentation including batch records and SOPs.
  • Provide support for calibration, maintenance, and validation activities.
  • Review and release batch record runs.
  • Adhere to safe manufacturing practices.

Qualifications

  • Bachelors in Science or Engineering with a minimum of 7 years of experience in a manufacturing pharmaceutical or biological products with at least 2 years leading people.  Master’s degree in Science or Engineering is preferred.
  • Experience working with pilot- or commercial-scale processing equipment such as stirred-tank bioreactors, continuous-flow centrifuges, ultrafiltration skids, process tanks, and automated CIP/SIP systems.
  • Experience working in a cGMP environment, including in-depth knowledge of current Good Manufacturing Practices, validation, process engineering, quality system regulations, and ISO standards.
  • Confidence, initiative, strong interpersonal and collaborative skills, and good personal organization skills.
  • Ability to work on multiple tasks simultaneously and meet project deadlines.
  • Ability to independently identify problems and effectively offer solutions to problems.
  • Effective working style in cross-functional teams and a commitment to working in a fast-paced environment.
  • Demonstrated ability to improve quality, reduce cost, and resolve complex problems through comprehensive analysis of critical data.
  • Experience with process technical transfer from development into cGMP manufacturing is required.
  • Project Management and Materials Management knowledge a plus.

 

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

 

Be part of our WACKER family, across all nations!

 

We are looking forward to your online application at www.wacker.com.
Reference Code: 5002 

 

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The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job. A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis.  Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a Green card).

 

WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.


Nearest Major Market: San Diego