CBM

Full Time EE - Onsite

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.

Summary

The Manufacturing Support Services Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing support by performing routine cGMP cleaning, assembling, transfer, and decontamination activities that aid in gene therapy production. The incumbent will embrace and promote right-first-time culture by supporting the manufacture of viral vectors, non-viral vectors, and advanced therapeutics while maintaining compliance to cGMP standards.

We are looking for individuals that have experience as a goal and solution-oriented team player, are hard-working, highly motivated, and eager to contribute to building a manufacturing operation. 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, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a supervisor role.

Responsibilities

• Work in a hands-on capacity to prepare buffers, assemble jumper harnesses, and clean/sterilize equipment and materials.
• Work closely with manufacturing personnel by transferring/stocking critical materials and delivering samples throughout the facility.
• Clean GMP spaces, collect waste from production suites, and perform decontamination protocols.
• Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
• Ensures work is completed in compliance with approved SOPs, batch records, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
• Proactively assist in the resolution of manufacturing support deviations/non-conformances and troubleshooting of support process and equipment problems.
• Lead and motivate operational staff by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
• Provides timely technical input, when necessary, to support ongoing operations.
• Assist with on-the-floor review of batch records in real time.
• Assist in the development of training material to support the initial and ongoing training of manufacturing support personnel.
• Identify opportunities for improvements in process, safety, quality, and cost.
• Lead training of new manufacturing support associates.
• Leads initiative to assist in validation activities related to the qualification of the manufacturing support process, facility suites, and equipment.
• Acts as qualified trainer for SOPs and procedures in functional area.
• Verify inventory and escalate to supervisor when supplies are low.

Education & Experience

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A minimum of 4-6 years of experience in cGMP biological manufacturing. Contract, Development, and Manufacturing Organization (CDMO) experience preferred.
• A minimum of 1-3 years of leadership experience.
• Advanced experience working with autoclaves, washers, aseptic operations, and cleanroom decontamination procedures is highly preferred.
• Advanced knowledge of cGMP regulations.
• Proven ability to troubleshoot and resolve equipment and processing issues.
• Advanced efficiency working in a Biological Safety Cabinet (BSC).
• Demonstrated ability working with pipettes, micropipettes, and scales.
• Demonstrated experience working with decontamination practices for materials and liquids.
• Demonstrated experience handling and formulating cleaning solutions.
• Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
• Exhibits extreme attention to detail, accuracy in work, and integrity of character.
• Self-starter who shows eagerness to learn and problem-solve.
• Innovative and efficient when solving problems with a strong focus on continuous improvement.
• Possesses sound technical aptitude to learn and operate production equipment.
• Ability to teach, lead and mentor co-workers.
• Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
• Able to accommodate a flexible work schedule to support business demands.
• Strong written and verbal communication skills, with excellent teamwork aptitudes. 

Physical Demands

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