Summary

The Vector Bioprocessing Associate I 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 and downstream 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 the processing tasks to support both upstream and downstream manufacturing.
• 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.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A range of 0-2 years of 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 and purification equipment.
• 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.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

Summary

The Vector Drug Product Bioprocessing Associate II 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 aseptic filling equipment and performing production support activities while maintaining compliance to cGMP standards. May be expected to support other areas of manufacturing when aseptic filling is not ongoing.

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

Responsibilities

• Work in a hands-on capacity within a cleanroom environment to perform aseptic filling, inspection, labeling, and packaging of Drug Product.
• 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.
• Assist in validation activities related to the qualification of the manufacturing process, facility suites, and process equipment.

Qualifications

• High school diploma is required, but a bachelor’s degree in biological science(s) field or related engineering is preferred.
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
• A minimum of 2 year of experience in cGMP biological manufacturing. Vector manufacturing or other gene therapy is highly preferred.
• Working knowledge of cGMP regulations.
• Experience working in a Biological Safety Cabinet (BSC).
• Effective written and verbal communication skills, with excellent teamwork aptitudes.
• Experience working with aseptic filling equipment and isolators is preferred.
• Experience working with pipettes, and micropipettes.
• 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 ability to learn and problem-solve.
• Exhibits 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

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

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

Summary

The Deviation Investigator will own and investigate all Manufacturing related deviations. The Deviation Investigator will work with cross functional stakeholders to perform simple and complex root cause analysis to root cause and identify corrective actions to close assigned investigations on time.

The role will support all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make Center for Breakthrough Medicines (CBM) a best-in-class Contract and Development Manufacturing Organization (CDMO).

Responsibilities

• Investigation of manufacturing deviations to determine root cause and implementation of corrective actions to prevent recurrence.
• Work with cross functional teams to gather data, lead and perform Root Cause Analysis to determine the likely root cause of the event.
• Assessment of event for overall impact.
• Identification of Corrective and Preventative actions to prevent recurrence.
• Management of multiple investigations concurrently.
• Provide routine client updates to communicate status and alignment on investigation findings.
• Ability to communicate roadblocks and challenges in a timely manner that can impact task and timely delivery of investigation.

Qualifications

• BS in Life Sciences or Engineering discipline required; Master’s degree preferred
• Related pharmaceutical experience required, including relevant experience in manufacturing in a GMP environment
• Experience utilizing root causes analysis tools and identifying corrective and preventative actions is required.
• Prior experience in Manufacturing Environment or troubleshooting Manufacturing related issues preferred.
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent organizational skills and attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Strong analytical and problem-solving skills.
• Ability to prioritize tasks.
• Ability to work well on a team.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite or related software.
• Ensures accuracy and relevance of assigned training curriculum.
• Drives timely completion of training for employees to meet regulatory requirements

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

Summary

Center for Breakthrough Medicines is seeking a VV Manufacturing Project Specialist for the execution of Technology Transfer for New Product Programs and Campaign Readiness Activities within the organization’s VV Manufacturing platform. The role will support all aspects of the Viral Vector Philosophy, Strategy, and Execution Plan to make Center for Breakthrough Medicines (CBM) a best-in-class Contract and Development Manufacturing Organization (CDMO).

Responsibilities

• Execution and oversight of Technology Transfer activities for designated New Product Programs and deliverables for VV Manufacturing
• Maintain a culture of Safety, Quality, On-Time Delivery, and Operational Performance based on CBM Goals and Vision
• Maintain cost mindfulness and promote innovation and team work to meet or exceed revenue and EBITDA targets
• Strong focus on batch success and transparency with each assigned program
• Participate as a key member of the Program Project Teams, working cross-functionally to complete deliverables on time in full
• Escalate issues that would jeopardize the Program, timeline, and milestones
• Development and review of batch records, SOPs, training modules, bill of materials, and Process Development milestones for tech transfer projects
• Own CAPAs, Change Controls, and Deviations as required
• Drive on-time batch release
• Assist and participate in the clean room execution as new programs launch
• Ensure equipment installation and readiness for operational schedule
• Client Facing to support Tech Transfer, Person-In-Plant (PIP) communication and client requests
• Work closely with Process Development to execute on-time technical transfer of new or optimized programs
• Support Quality Audits, Supplier Audits, and Regulatory Inspections
• Support new equipment on-boarding through review and approval of IQ/QQ/PQ documents
• Follow Operational Excellence Standards with department and company goals in mind
• Ensure detailed project planning for tech transfers and on time start dates for all programs

Qualifications

• The ideal candidate is preferred to have a Bachelor’s degree in a technical or applicable discipline or equivalent.
• The ideal candidate is preferred to have minimum 2+ years experience or equivalent
• Regulatory experience with FDA, EU Commercial and Clinical Manufacturing is preferred
• Knowledge of SAP or equivalent ERP systems
• Strong Cross Functional Communication skills
• Strong knowledge of Bio-Manufacturing, cGMP, and Quality Standards
• Shopfloor support is required, and the candidate must be comfortable with Clean Room gowning and can access and walk the floor daily
• This is a dayshift position, reporting M-F however the candidate must be able to be flexible to support 24/7, especially during critical validation or operational times
• Candidate must be prepared for an exciting, dynamic, and fast paced CDMO/start up environment

Technical Skills and Experience preferred for the role:

• Upstream Processing (Cell Culture, Cell Expansion, Transfection/Infection of Cells)
• Downstream Processing (Purification, Column Chromatography, Ultra Centrifugation, Filtration)
• Drug Product Processing (Formulation, Aseptic Filling, Vial Inspection, and Packaging)
• Solution preparation and single use component preparation and sterilization
• Technical Transfers
• Equipment and Material Procurement
• Detailed Project Planning
• Document Creation
• Quality Change Controls, CAPAs, Deviations
• Participation in Risk Assessments
• Problem Solving

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

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.

As an Equal Opportunity Employer, we believe in each person’s potential. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, national origin, sexual orientation, gender identity, disability or any other protected category including veteran status.

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.