Senior Manufacturing Associate

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Date: Jan 10, 2023

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 Associate]]​ to be a part of our growing team.

 

 

Job Responsibilities

  • Manufacture bulk drug substance through various manufacturing unit operations, which include fermentation, chemical lysis, chromatography, and final bulk filtration.
  • Experience working in a cGMP cleanroom environment, including familiarity with cGMP documentation practices and process deviation investigations
  • Operate large scale fermenter, centrifuge, lysis/depth filtration skids, ultrafiltration/diafiltration (UF/DF), and chromatography skids/columns
  • Chromatography processing through both manual methods and automated computer systems.
  • Column packing method: manual and slurry packing station (SPS). Column volumes up to 60-liters.
  • Completes and maintains documentation related to assigned work, including batch records and logbooks
  • Assemble and prepare equipment for production
  • Dispensing of buffer preparation components
  • Perform media and buffer preparation activates
  • Sterile filtration and filter integrity testing
  • Clean in Place (CIP) and Steam in Place (SIP) of tanks using automated systems
  • Clean out of Place (COP)/Glasswash of misc. parts and equipment
  • The Manufacturing Associate will work with other manufacturing associates and engineers to implement and validate new processes and procedures, troubleshoot equipment, and optimize overall system performance.
  • In addition, the Manufacturing Associate will assist the facilities and metrology department during periodic plant shutdowns to coordinate equipment maintenance and instrument calibration.
  • Some after-hours work and participation in a rotating after-hours process control function will be required.

 

Qualifications

 

  • Bachelor’s degree in Sciences or related discipline with experience in a cGMP manufacturing pharmaceutical/biotechnology environment.
  • 0-2 yrs. for Associate I, 2-4 yrs. for Associate II, and 5-7 yrs. for Associate III/Senior Associate.

 

KSAs:

 

  • Experience working with pilot- or commercial-scale processing equipment such as stirred-tank bioreactors, continuous-flow centrifuges, ultrafiltration skids, process tanks, automated process equipment, and automated CIP/SIP systems.
  • Experience with various vendor chromatography skids. Experience with, AEX, IEX, and HIC chromatography resin. Mab resin a plus.
  • Experience working on cross-functional teams and a commitment to working in a fast-paced
    environment.
  • Experience working in a cGMP environment, including in-depth knowledge of current Good
  • Manufacturing Practices, validation, process engineering, quality system regulations, and ISO standards
  • The ability to communicate clearly and precisely, both orally and in writing
  • Confidence, initiative, strong interpersonal and collaborative skills, and good personal
    organization skills
  • Ability to independently identify problems and effectively offer solutions to problems
  • Ability to work on multiple tasks simultaneously and meet project deadlines

We are looking forward to your online application!

Reference Code: 16399 

 

 

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.

In accordance with the Internal Placement Policy, you must be in your current role for at least one year, and must inform your current supervisor prior to applying for a new position.  If you have any questions or concerns, please contact your local HR department.

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