Position Overview:

Beam is looking for a highly talent and motivated Senior Specialist, Product Quality Assurance to join our growing Quality team. The Senior Specialist, Product Quality Assurance will be responsible for supporting Quality's oversight of laboratory and manufacturing operations at Beam's manufacturing facility in Durham, North Carolina. Beam's manufacturing facility is focused on advanced therapeutic manufacturing technologies (cell and gene therapy modalities). The facility is currently focused on clinical phase manufacturing with the intent of moving several programs to be commercial within the same facility. Reporting into the Director, Product Quality Assurance, this role will provide Quality oversight of routine manufacturing, testing, and related operations to ensure that systems and processes are maintained in compliance with Good Manufacturing Practices (GMP), and ultimately to Good Distribution Practices (GDP) as the programs move to the commercial phase. This role will also provide Manufacturing Shop Floor Quality presence and may require support on first or second shift as required by plant scheduling.

Primary Responsibilities:

• Provide Quality oversight of on-the-floor activities including manufacturing shop floor presence during operations.
• Provide Quality oversight of QC testing.
• Responsible for ensuring GMP compliance with applicable procedures and production requirements in QC, manufacturing, and facilities operations.
• Responsible for assisting with product disposition activities of supply produced at the manufacturing facility.
• Real time review of batch records and labels.
• Review and approval of manufacturing discrepancies and associated CAPA’s.
• Communicating lot disposition pending issues to management.
• Aid in the development and ongoing improvement of applicable quality systems for the site; identifying gaps or improvements, authoring and approval of procedures, and providing training, as needed.
• Review and approve calibration and maintenance work orders and asset inductions.
• Support approval of protocols when required.
• Provide Quality support towards resolution of material, product, environmental, facility and equipment manufacturing issues.
• Responsible for supporting functional and facility goals and objectives.
• Responsible for supporting and contributing to quality metrics for the facility.
• Responsible for supporting and participating in regulatory inspections.
• Responsible for communication and escalation of significant issues that may impact patient safety, product quality, supply, regulatory compliance, or company impact to senior management.

Qualifications:

• Bachelors or Advanced degree in a scientific discipline with 10+ years’ experience in the pharmaceutical/biotech industry in combination with drug substance/drug product manufacture, development and/or quality.
• Knowledge of aseptic processing, and/or cell and gene therapy is preferred.
• Apply Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
• Excellent verbal and written communication skills, detail-oriented personality, and ability to work collaboratively across functions.
• Knowledge of global regulations and standards.
• Strong team player that has a customer service approach and is solution oriented.
• Attention to detail and the ability to work individually as well as within a multi-disciplinary team.
• Excellent listening, communication and interpersonal skills with a team focus.
• Consistent delivery of high-quality work.
• Ability to gown and work in a cleanroom environment.
• Must be able to work onsite daily and willing to have a flexible schedule during peak times, which may include supporting critical operations outside of normal work hours, as needed.
• Ability to support 2nd shift schedule.

Position Overview:

The QC Manager, Raw Materials will be responsible for developing, leading, and managing the Raw Materials QC program at the Beam Therapeutics Manufacturing facility in Durham, NC. This role will develop and maintain documentation regarding testing requirements and strategies, serve as a subject matter expert (SME) for raw materials issues, providing technical expertise aligned with current GMPs and current industry practices. This person will have knowledge and experience with USP methods, and the ability to apply as required, and as well as maintaining compliance to USP, ICH and FDA guidance documents. Interface with Manufacturing, Supply Chain, and Quality Assurance leadership and participate and/or lead interdepartmental teams to address quality-related issues.

This role requires on-site presence and engagement. The position will report to the Quality Control Senior Director.

Primary Responsibilities:

• Build and manage the raw materials QC program at the Beam Therapeutics Manufacturing facility.
• Develop and maintain all documentation with regards to testing requirements and strategies, including material specifications.
• Serve as a SME for raw materials issues, providing technical expertise aligned with current GMPs and current industry best practices.
• Manage contract laboratories as needed.
• Own and author risk assessments for raw material programs.
• Support supplier change notifications and material enrollment.
• Identify need for development of new assays with compendial and GxP requirements.
• Accountable for managing the raw materials testing program to ensure quality, product specifications and adherence to all current GMPs, USP, ICH and FDA guidance documents.
• Evaluate QC systems and recommend and/or implement system improvements.
• Author technical protocols and reports for Raw Materials testing qualification, validation, or verification.
• Author test methods and SOPs for the Raw Materials testing program.
• Create, review, and approve out-of-specification (OOS) and out-of-trend (OOT) investigations, deviations, CAPAs, and Change Controls.
• Manages release of raw materials used in manufacturing.
• Provide oversight of material master data as it relates to inspection plans and material life cycle.
• Maintain records and databases in accordance with procedures.
• Hire and manage staff as needed.
• Oversee management of in-house raw material test equipment.

Qualifications:

• Bachelor’s or advanced degree in biology, biochemistry or closely related scientific discipline.
• At least 7-10 years of CGMP QC experience in a cell therapy/biotech/pharmaceutical setting is required.
• Expert knowledge of pharmaceutical/biotech Raw Materials testing is required.
• At least 3 years of management experience is required.
• Basic knowledge of qualifications and validations; current industry practices; and strong experience with guidance interpretation and application.
• Knowledge of cGMPs, ICH, USP, FDA requirements is required, including equipment and method validation/verification.
• Experience with risk assessment tools is desired
• Excellent critical thinking and technical writing skills.
• Excellent interpersonal and communication skills to lead, facilitate and follow.
• Computer skills required to use Microsoft Word, Project, Visio, and Excel programs.