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 Center for Breakthrough Medicines is seeking a Microbiological Quality & Sterility Assurance (MQSA) Senior Specialist to join the Quality & Compliance team. This position will be involved in programs to ensure microbiological quality and sterility assurance of sterile product at the Center for Breakthrough Medicines, while adhering to applicable regulatory requirements and industry best practices.

The Senior Specialist will ensure compliance of aseptic manufacturing, environmental monitoring, and microbiological contamination control measures. The position will collaborate with Microbiology and Manufacturing partners to support ongoing aseptic training program to including gowning, aseptic technique and cleanroom behavior. The Senior Specialist will be responsible for routine administration of the site aseptic process simulation (APS) program, in addition to supporting the site contamination control strategy (CCS).

It will be the responsibility of the Senior Specialist to build impactful relationships and collaborate across the Center for Breakthrough Medicines organization to deliver exceptional service and the highest quality product to our clients in a highly regulated environment.

If you have experience executing Sterility Assurance program elements, we encourage you to consider building your future with The Center for Breakthrough Medicines.

Responsibilities

• Supports development and lifecycle management of the contamination control governance elements, including sterilization validation, environmental monitoring, cleaning & disinfection, and utilities qualification (e.g. WFI system, compressed gases)
• Helps in the development and implementation of the site Sterility Assurance Program
• Participates in the administration of end-to-end (E2E) microbiological control strategy for production processes from incoming raw materials through final product release
• Collaborates with Manufacturing to meet US and EU aseptic processing requirements
• Adheres to industry regulations and guidance documents when assisting in the creation and implementation of standards, policies, and site procedures (e.g., ISO 14644, Sterile Drug Products produced by Aseptic Processing-GMP, EU Annex1, and EU Guideline-GMP Specific to Advanced Therapy Medicinal Products)
• Supports compliance of site manufacturing programs, processes, and facility systems
• Performs gap assessments and collaborates in the implementation of action plans to correct identified deficiencies to improve quality processes
• Provides sterility assurance expertise as author, reviewer and/or approver for cGMP documents including, but not limited to, SOPs, work instructions, and batch records
• Authors/supports APS/media fill protocols and summary reports to ensure robust and compliant documentation of processes and validation studies
• Participates in the development of cGMP and other GxP training as needed
• Provides microbiological expertise to support non-conformances, deviations, CAPAs and complaints related to sterility assurance
• Supports preparation for regulatory and client audits
• Supports sterility/microbial specification development for incoming raw materials and components.
• Collaborates with internal and external business partners, including other CBM business units or departments and external suppliers, in support of continuous improvement initiatives

Qualifications

• Collaborative nature and ability to work well in teams
• Capable of data analysis, including ability to collect and analyze data to identify trends and detect problems and key issues
• Demonstrates good judgement; able to problem solve and to define decision criteria to recommend the most appropriate course of action
• Ability to plan and organization to meet goals and objectives within defined timelines
• Possesses strong communication skills – oral and written

Education & Experience

• Bachelor’s Degree in Microbiology, Biology, Chemical Engineering, Biomedical Engineering or closely related discipline
• 5+ years of experience in pharma/biotech industry; minimum 3 years of aseptic processing experience in a GMP environment
• Demonstrated experience in Aseptic Process Simulation (APS) execution
• Cell and Gene Therapy experience a plus
• Knowledge of analytical methods relevant for microbial control
• Experience in microbiology, sterilization validation, terminal sterilization, aseptic processing and environmental controls for a pharmaceutical, medical device or related manufacturing environment
• Proven track record troubleshooting process non-conformances and out-of-specification test results
• Proficient in providing sound and compliant resolutions to issues utilizing robust CAPA processes

Summary

Center for Breakthrough Medicines is seeking an experienced Training Coordinator to support the learning, development, and qualification needs across the functional units at CBM. The Training Coordinator will play a critical role in coordinating training and compliance activities which are essential to ensure personnel are trained prior to the commencement of GMP activities and site operations. The Training Coordinator under general supervision from the Managers and Director of the Training Department, will provide Learning Management System (LMS) support and administration in accordance with requirements specified per Standard Operating Procedures (SOPs). The position provides service and support to internal customers at all levels of the organization. The training coordinator will assist managers in determining training needs and requirements. Utilizing the LMS software system, the training coordinator will identify, create, and track training for all departments. Through knowledge and commitment, the Training Coordinator will create a collaborative team environment for their colleagues.

Responsibilities

• Set up classroom training sessions, versional documents, and track in-class, on-line, onsite and offsite, vendor training within the LMS software
• Enter training attendance sheets into the LMS system as needed
• Assist departments in defining training requirements and determining timelines
• Work closely with department managers to ensure training is available when needed and completed when required
• Manage the process that assigns courses to associates
• Develop, run, and distribute reports as scheduled or upon request for management and/ or internal/ external audit purposes
• Support the process that assigns courses to associates
• Input content into LMS using pre-determined organizational structure and naming convention (i.e.- curricula)
• Communicates training needs to local training management
• Remain current on LMS software changes and developments in field(s) of expertise

Qualifications

• High School Degree or higher
• 1 year experience in GMP environment
• 1-3 years’ experience with learning management systems (LMS)
• Proficient in Microsoft Office, PowerPoint, Excel and Outlook applications and basic HTML
• Excellent organizational skills and attention to detail
• Able to accommodate a flexible work schedule to support business demands.
• Outstanding written and verbal communication skills
• Ability to handle multiple assignments and assess and analyze data

Preferred Skills

• Knowledgeable about instructional design and e-learning platforms
• Technical skills to manage and update course content, create and manage user accounts and manage the LMS system.

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 Warehouse Associate to perform a variety of warehouse operations, including receiving, put-away, inventory management and material movement.

The Warehouse Associate collaborates and communicates with warehouse personnel, logistics technicians, customer service representatives, service providers, and others involved in the shipment and receipt of products. S/He also keeps updated logs by tracking, tracing, and updating the status of incoming and outgoing shipments.

Responsibilities

• Perform the daily warehouse activities to meet the demands of clinical and commercial manufacturing in a timely manner to ensure no delays in supply chain
• Move equipment from warehouses to campus
• Manage the shipment and receipt of all products, materials, and supplies.
• Track, trace, and update the status of incoming and outgoing shipments.
• Maintain a clean, neat, and member-ready area.
• Promptly unload trucks and deliveries.
• Sort and stock receivables.
• Scan and sort incoming and outgoing stock
• Work with external vendors, couriers, custom agents to facilitate shipments
• Communicate necessary information internally and externally as required. Work across internal functions to communicate the timelines to prevent any delays
• Comply and adhere to Good Manufacturing Practices (GMP), Good Distribution Practices (GDP) and Good Import/Export Practices for all activities Ensure efficient daily operations of the warehouse team
• Demonstrate an understanding of the company quality policy
• Communicate well with leadership, team members and other departments

Qualifications

• High School Diploma, GED, or equivalent
• 6 months logistics, retail, or customer service experience
• Good written and verbal communication skills
• Strong sense of time organization and urgency
• Able to work independently and within a team

Physical Demands

Lift up to 70lbs

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.

Summary

The Supply Chain Lead (E2E (end-to-end) Business Unit Planner III) is the key Supply Chain contact to an assigned Business Unit for managing materials (including raw materials, components and supplies), ensuring that materials are available in a timely manner within budget, based on Business & Client needs.

Assumes full responsibility for comprehensive planning from new client intake to end of contract. The Planner maintains accurate demand forecasts, BOMs, BOOs (routings) and planning parameters for MRP, and executes based on guidelines and policies to accomplish these goals, leveraging their experience and judgement as needed.

The Planner helps to resolve a wide range of complex issues using analytical and problem-solving abilities. With familiarity of the end-to-end Supply Chain process and in-depth knowledge of Planning, the Planner helps to train others on how to execute their job responsibilities and ensures SOPs/WI are aligned with current processes.

Responsibilities

• Plans materials necessary for business unit operations and client programs (not responsible for establishing new suppliers or negotiating contracts).
• Creates demand forecast (plan) at Business Unit level aligned to Sales & Operations Planning (S&OP) for active & pipeline client programs.
• Actively participate in S&OP meetings, challenging as appropriate and addressing concerns.
• Check MRP-generated purchase proposals, align with business to manage exceptions.
• Set-up and maintain BOM (Bill of Materials), BOO (Bill of Operations) and planning parameters in MRP/ERP system.
• Represents Supply Chain for new client intake and material readiness assessment / planning.
• Manages materials based on defined replenishment policies and planning parameters (e.g. safety stock, lead times, etc.).
• Exercise a good working knowledge of materials and sources of supply to validate proposed purchase requisitions.
• Determine material requirements from assigned Business Units and production schedules and coordinate the efficient movement of materials through production cycle.
• Collaborating with Business Units creates unconstrained production plans and manage short-term exceptions or constraints as part of the MRP process.
• Manages inventory in optimal manner, aligned to CBM inventory targets and strategies.
• Provides analysis and proposes strategies for additional optimization.
• Execute job responsibilities ensuring we maintain the highest quality standards to support CBM Quality and GMP compliance.
• Maintain metrics and initiate changes / improvements based on results.
• Drive Lean activities and initiatives in Planning area.
• Support EHS (Environmental, Health & Safety) activities and initiatives.
• Perform other duties/special projects as assigned.
• Work with receiving, finance and suppliers to reconcile discrepancies in receiving and invoicing.
• Resolves a wide range of complex Planning issues that may arise.
• Provides input to optimize inventory / replenishment policies.
• Train others on how to execute Planning tasks & generate reports in SAP.
• Reviews SOPs/WI to ensure aligned with current processes.
• Provides assessment of material readiness at all stages of product lifecycle, from initiation to tech transfer to commercialization.

Qualifications

• Bachelor’s degree in a Supply Chain or related field, certification, or relevant work experience.
• 8+ years of material planning in a manufacturing setting, 6+ years with a Master’s Degree, or 3+ years with a PhD (preferred).
• Previous experience in a Life Sciences, Pharmaceuticals, or Medical Devices environment (preferred).
• Experience with MRP / ERP systems.
• Experience in supply chain management and inventory control.
• APICS Certification (CPIM, CSCP) (preferred).
• Excellent verbal and written communication skills.
• Excellent interpersonal and customer service skills.
• Excellent sales and customer service skills.
• Excellent organizational and time management skills with attention to detail.
• Excellent time management skills with a proven ability to meet deadlines.
• Excellent analytical and problem-solving skills.
• Ability to function well in a high-paced and at times stressful environment.
• Proficient with Microsoft Office Suite.
• Effective collaboration with remote colleagues.
• Able to analyze data and interpret trends using Microsoft Excel.
• Focused ability to prioritize tasks and to delegate them when appropriate.
• Able to identify Lean / process improvement opportunities.
• Excellent understanding of how Planning works, able to train others.
• Understand basic statistical concepts related to forecasting & variation (preferred).