Job Description
Company Overview:
Beam Therapeutics is a biotechnology company committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform with integrated gene editing, delivery and internal manufacturing capabilities. Beam’s suite of gene editing technologies is anchored by base editing, a proprietary technology that is designed to enable precise, predictable and efficient single base changes, at targeted genomic sequences, without making double-stranded breaks in the DNA. This has the potential to enable a wide range of therapeutic editing strategies that Beam is using to advance a diversified portfolio of base editing programs. Beam is a values-driven organization committed to its people, cutting-edge science, and a vision of providing life-long cures to patients suffering from serious diseases.
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.
The salary range below reflects the full-time base salary range we expect to pay for this role at the time of posting. Base pay will be determined based on several factors including, but not limited to, relevant experience, education, scope of job, internal comparisons, and market data.
Beam Pay Range
$155,000—$190,000 USD