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

Summary

Center for Breakthrough Medicines is seeking a VV Manufacturing Project Lead/Sr. VV Manufacturing Project Lead 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

Summary

The Deviation and Quality Records Supervisor will provide investigation leadership and compliance support for Viral Vector Manufacturing deviations as well as oversight of Corrective and Preventative actions. The Supervisor will work with stakeholders to perform complex root cause analysis and identify corrective actions and ensure the Viral Vector Manufacturing team is audit ready.

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

• Direct supervision of a team of investigators.
• Coaching and mentoring investigators on common root cause analysis techniques.
• Provide oversight of investigations management to ensure timely and compliant closure in collaboration with Quality Assurance.
• Report metrics for investigation activities.
• Attend appropriate meetings to report out on investigations and investigation metrics for Manufacturing Operations.
• Presentation of critical investigation findings to key stakeholders and senior leadership.
• Actively develop, promote, and implement safe work practices to ensure safe working conditions for all employees while maintaining permanent inspection readiness

Qualifications

• BS in Life Sciences or Engineering discipline required; Master’s degree preferred
• 3 to 5 years of 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.
• Experience with viral vector manufacturing/support preferred
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent sales 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.
• Strong supervisory and leadership skills.
• Ability to prioritize tasks and to delegate them when appropriate.
• Ability to lead multi-disciplinary project teams.
• 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

Education & Experience

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.