Viral Vector Manufacturing Lead Associate
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Viral Vector Manufacturing Lead Associate

King of Prussia, PA

The Center for Breakthrough Medicines is on track to be the largest single-site cell and gene therapy contract development and manufacturing organization in the world. Our comprehensive service offering accelerates speed to market through supply chain disruption mitigation strategies, end-to-end program management expertise and unique platform technology with the ability to follow a molecule from idea to commercialization. CBM’s integrated approach provides high quality and consistent end-to-end manufacturing capability including: Process and Analytical Development; Plasmid DNA production; Viral Vector Production of Lentivirus; AAV and Adenovirus; Testing and Analytics; Autologous, Allogeneic and Gene-edited Cell Therapy Bioprocessing; and Cell banking. CBM’s horizontal and vertical integration provides one source throughout a product’s life cycle.

CBM’s mission is to accelerate the delivery and affordability of lifesaving and life-changing therapies from discovery to market by offering a complete solution for the development and commercialization of cell and gene therapies.

CBM is located just outside of Philadelphia in the Heart of Cellicon Valley on The Discovery Labs campus set on 300 acres with 2.4 million square feet of life sciences lab and manufacturing space, allowing clients to scale their development and manufacturing needs without ever having to change sites, while providing employees a true community campus experience focused exclusively on life sciences.

The Discovery Labs is a Global Platform Company inclusive of CBM, The Discovery Labs Properties, UniteIQ incubator labs, and The Colony, a unique investment and resource model enabling groundbreaking therapies to be brought to life.

Summary

The Viral Vector Manufacturing Lead Associate will serve as an exemplary role model to guide and lead a diverse manufacturing team towards achieving on-time delivery of manufacturing operations for our multiproduct cGMP gene and cell therapy site.

The incumbent will embrace and promote right-first-time culture while operating upstream and downstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.

The individual will be a hard-working, motivated, goal and solution-oriented team player eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. The individual will also have a willingness and aptitude for adoption of new technology, an ability to build relationships and work effectively in a cross-functional team and show commitment to the highest safety and quality standards.

This position requires multi-tasking, wearing many hats, and has the potential to evolve into a supervisor role.

Responsibilities

  • Lead and motivate operational staff, promote a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Work cross-functionally in a hands-on capacity to perform cell culture scale-up, operate single use bioreactors and ÄKTA chromatography/TFF equipment, Ultracentrifugation, Final Fill Finish, prepare media and buffer solutions, and clean/sterilize equipment as required.
  • Ensure work is completed in compliance with controlled documentation (SOPs, batch records, forms, etc.) and all applicable guidelines, safety policies and procedures are followed.
  • Assist in on-the-floor review of batch records.
  • Assist in the development of training material to support the initial and ongoing training of staff.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Work closely with Quality Assurance to proactively resolve issues such as deviations, CAPAs, and Change Controls, as necessary.
  • Assist in the resolution of manufacturing deviations and troubleshooting of process and equipment problems.
  • Author, revise, and review SOPs for equipment and processes.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Assist in validation activities related to the qualification of the inaugural manufacturing facility suites and process equipment. 

Qualifications

  • Bachelor’s degree in biological science(s) field or related engineering is preferred but not required.
  • A minimum of 3-10 years of experience in cGMP biological manufacturing. Viral vector manufacturing or other gene therapy is highly preferred.
  • 2-4 years of proven leadership experience.
  • Strong knowledge of cGMP regulations.
  • Able to adhere to all safety and company regulations.
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.
  • Excellent computer and word processing skills including Microsoft Excel, PowerPoint, and Word.
  • Detail-oriented; takes on ownership of work; innovative with a focus on continuous improvement.
  • Able to accommodate a flexible work schedule to support business demands. 

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing PPE.

Compensation: TBD

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