866-274-4009 Contact Us

Vector Manufacturing Supervisor

November 7, 2022

Summary

The Vector Manufacturing Supervisor will be responsible for helping to drive the on-time-delivery of manufacturing start-up activities for all aspects of vector upstream and downstream manufacturing. The incumbent will lead, guide, and train a diverse manufacturing team by performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines.

We’re looking for an individual who is a motivated self-starter and eager to contribute to building a manufacturing operation unparalleled in its capabilities and expertise. The individual should also have a willingness and aptitude for adoption of new technologies, an ability to build relationships and work effectively in a cross-functional team, and commitment to the highest safety and quality standards. This position has the potential to evolve into a manager role.

Responsibilities

  • Ensure high levels of communication with the team, support resources, and management regarding issue identification and resolution; develop formal communication protocols and tools including progress tracking systems, dashboards, and management reports, and any other product specific information as needed.
  • Oversees the manufacturing process, supervises upstream and downstream processing on the floor, and delegates daily work assignments.
  • Lead, motivate, and develop manufacturing personnel by promoting a culture of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • Understands and performs aseptic technique and identify unacceptable practices and can make spot corrections to performance.
  • Ensures work is completed in compliance with approved SOPs, batch records and controlled documentation and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Understands, trains, and coaches others on all operations, functions, and capability of equipment and is able to perform complex troubleshooting.
  • Identifies, suggests with options, recommends path forward and leads complex decision-making sessions.
  • Possesses basic and fundamental engineering and mechanical knowledge and is able to apply that knowledge in the manufacturing area, demonstrating unit operational and end-to-end understanding.
  • For escalations, works closely with the production staff to troubleshoot process and equipment
  • Responsible for maintaining the Vector Manufacturing facility and equipment to ensure constant compliance
  • Work closely with Quality Assurance and SPCI in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
  • Complete same-day review of completed batch records.
  • Oversees and adjusts training programs within the team, ensuring that manufacturing personnel are current on training requirements.
  • Proactively identify opportunities for improvements in process, safety, quality, and cost.
  • Train manufacturing and other team members on manufacturing procedures and especitc techniques, quality systems and compliance, and other operations required for cGMP manufacturing.
  • Assist in building out a full team of Vector Bioprocessing Associates at varying levels
  • Support CBM culture of “Be Committed, Ignite Innovation, Respect All, Embrace Customers, Empower Small, and Always be All In”.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • A minimum of 4 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • A minimum of 1-2 years of leadership experience is preferred.
  • Advanced experience working with single-use bioreactors, aseptic operations, cell culture, seed scale-up, filtration, concentration, chromatography, purification, etc. is highly preferred.
  • Advanced knowledge of cGMP regulations.
  • Advanced efficiency working in a Biological Safety Cabinet (BSC).
  • Demonstrated ability working with sterile tube welders, sterile tube sealers, and single-use assemblies.
  • Proven experience working with of cell expansion vessels such as T-flasks, shake flasks, cellstacks, hyperstacks.
  • Advanced 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.
  • Experience supervising, coaching, mentoring, and developing direct reports.
  • Strong background in process scale-up.
  • Outstanding written and verbal communication skills, with excellent teamwork aptitudes.
  • Demonstrated ability to plan daily activities for self and team and resolve problems in area of expertise.
  • Ability to lead and develop a team to accomplish individual and corporate goals.
  • Ability to accommodate off-shift work as required by business demand and manager request.
  • Position requires direct interaction with clients and is expected to spend 80-100% of time gowned on the Manufacturing Floor.

Physical Demands

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

Bioprocessing Training Coordinator

October 25, 2022

Summary

The Bioprocessing Training Coordinator will create the training program, training curriculums, training plans/content, and maintain training documentation for the manufacturing staff. The incumbent will be responsible for performing on the job training for manufacturing processes and operating basic equipment as required while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing staff for the stand up of a new organization.

We are looking for individuals that have experience training multiple people simultaneously, are hard-working, highly motivated, and solution oriented. This position requires multi-tasking, interdepartmental coordination, and excellent communication skills.

Responsibilities

  • Directly oversees on-the-job training needs with management, outside vendors, and/or clients in conjunction with the site training team.
  • Assist in maintaining the cGMP status of the manufacturing facility to always ensure inspection readiness.
  • Ensures timely completion and compliance with cGMP and all other relevant company training requirements and apply rigorous quality standards while executing training activities.
  • Tracks and reports key quality indicators, training metrics, and participant feedback.
  • Ensures work is completed in compliance with approved SOPs, controlled documentation, and all applicable regulations, guidelines, safety policies and procedures are followed.
  • Assist in the resolution of training deviations/non-conformances and troubleshooting of equipment problems as needed.
  • Facilitates training program and conducts trainer assessments of manufacturing personnel.
  • Develops training presentations including training documentation requirements, completions, rosters, certificates, and compliance to share with subject matter experts and work with manufacturing management to develop curricula.
  • Develops and updates on the job training requirements, curricula, and skill check assessment checklists as required with manufacturing, quality, and site support departments through job code reviews as the program develops or improvements are identified.
  • Creates all levels of training courses (instructor led, self-read, on the job, computer-based) using best training practices and analyzes training trends and reviews quality data to determine opportunities for continuous improvement.
  • Prepares and manages a technical training calendar and communication board. Facilitates scheduling of on-the-job training courses.
  • Develops mechanisms using the Quality Management System to ensure operators are trained and ready to execute.
  • Work together with the Training Department’s Specialist to ensure completion of all necessary orientation and onboarding training activities.

Qualifications

  • High school diploma is required, but a bachelor’s degree in biological science(s) field is preferred.
  • 3-5 years of GMP Manufacturing experience.
  • Experience performing and teaching aseptic technique.
  • A minimum of 1 year of technical training, including developing curriculum and course content – Preferred.
  • History of maintaining personnel training and performance metrics.
  • Strong knowledge of cGMP regulations and quality management systems.
  • Working knowledge of MS Word, PowerPoint, Excel, and Outlook.
  • Excellent written and verbal communication and interpersonal skills.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows eagerness to learn new opportunities and experiences.
  • Innovative and efficient when solving problems with a focus on continuous improvement.
  • Possesses aptitude to learn and operate equipment and apply emerging learning technologies.
  • Able to adhere to all safety and company regulations.
  • Able to accommodate a flexible work schedule to support business demands.
  • Knowledge of instructional design, blended learning, contemporary learning methodologies, and Vector Manufacturing is preferred.
  • Ability to manage, adapt to, and influence change in a high-pressure environment.

Physical Demands

  • Ability to carry up to 55 pounds.
  • Ability to stand for long periods of time while wearing various levels of PPE daily.
Contact Us Now

Vector Upstream Bioprocessing

October 19, 2022

Summary

The Vector Upstream Bioprocessing employee will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards.

We are looking for individuals that are willing to work within a team, are hard-working, and highly motivated. This position requires multi-tasking and excellent peer-to-peer communication skills.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment to perform cell culture scale-up and operate single use bioreactors.
  • 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.
  • Assist in the resolution of manufacturing deviations/non-conformances.
  • Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Education & Experience

  • High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
  • Experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
  • General knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • General knowledge of cell expansion vessels.
  • Ability to work well independently and as part of a team.
  • Exhibits attention to detail, accuracy in work, and integrity of character.
  • Self-starter who shows willingness to learn and problem-solve.
  • Willingness to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • 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 daily.
Contact Us Now

Vector Upstream Bioprocessing Lead Associate

January 10, 2022

Summary

The Vector Upstream Bioprocessing Lead Associate will serve as a role model to lead a diverse team towards achieving on-time delivery of manufacturing operations by performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will embrace and promote right-first-time culture while operating upstream equipment for adherent and suspension systems and performing production support activities 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 within a cleanroom environment to perform cell culture scale-up and operate single use bioreactors.
  • Lead and motivate operational staff on a daily basis by promoting a culture. of inclusiveness, safety, continuous improvement, training objectives, and compliance.
  • 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 deviations/non-conformances and troubleshooting of process and equipment problems.
  • Provides timely technical input 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 personnel.
  • Identify opportunities for improvements in process, safety, quality, and cost.
  • Lead training of new Bioprocessing associates.
  • Leads initiative to assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.
  • Acts as qualified trainer for SOPs and procedures in functional area.

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 5 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • A minimum of 1-3 years of leadership experience is preferred.
  • Experience working with single-use bioreactors, aseptic operations, cell culture, and seed scale-up.
  • 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 incubators, pipettes, and micropipettes.
  • Demonstrated ability working with sterile tube welders, sterile tube sealers, and cell counting machines.
  • Experience working with of cell expansion vessels such as T-flasks or shake flasks.
  • 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.
  • Advanced experience working with single-use bioreactors, aseptic operations, and seed scale-up is highly preferred.
  • 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.
Contact Us Now

Vector Upstream Bioprocessing III Associate

Summary

The Vector Upstream Bioprocessing III Associate will be responsible for performing routine cGMP manufacture of viral vectors, non-viral vectors, and advanced therapeutics supporting the gene therapy asset at the Center for Breakthrough Medicines. The incumbent will be responsible for operating upstream equipment for adherent and suspension systems and performing production support activities while maintaining compliance to cGMP standards. This position will participate in the onboarding and training of the inaugural manufacturing staff for the stand up of a new organization.

We are looking for individuals that have experience working within a team, are hard-working, highly motivated, and solution oriented. This position requires multi-tasking, interdepartmental coordination, and excellent peer-to-peer communication skills. This position has the potential to evolve into a lead role.

Responsibilities

  • Work in a hands-on capacity within a cleanroom environment to perform cell culture scale-up and operate single use bioreactors.
  • 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.
  • Assist in the resolution of manufacturing deviations/non-conformances and troubleshooting of process and equipment problems.
  • Assists with the training of Bioprocessing associates.
  • Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

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 3 years of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy experience is highly preferred.
  • Strong knowledge of cGMP regulations.
  • Experience working in a Biological Safety Cabinet (BSC).
  • Strong written and verbal communication skills, with excellent teamwork aptitudes.
  • Experience working with single-use bioreactors, aseptic operations, cell culture, and seed scale-up is highly preferred.
  • Demonstrated ability to troubleshoot and resolve equipment and processing issues.
  • Strong knowledge of process validation practices for biopharmaceutical products.
  • Proven efficiency working in a Biological Safety Cabinet (BSC).
  • Experience working with incubators, pipettes, and micropipettes.
  • Experience working with sterile tube welders, sterile tube sealers, and cell counting machines.
  • Experience working with of cell expansion vessels such as T-flasks or shake flasks.
  • Proven ability to work well independently, as part of a team, and establish working interdepartmental relationships.
  • Exhibits 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 focus on continuous improvement.
  • Possesses technical aptitude to learn and operate production equipment.
  • Able to adhere to all safety and company regulations.
  • 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 daily.
Contact Us Now