Company Overview:

Beam Therapeutics is committed to establishing the leading, fully integrated platform for precision genetic medicines. To achieve this vision, Beam has assembled a platform that includes a suite of gene editing and delivery technologies and is in the process of building 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 potential 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:

Beam is seeking a Manager/Senior Manager of External Manufacturing who will be responsible for overseeing manufacturing production at contract manufacturing organizations to support timely product delivery. This is a key leadership role that requires contract and project management leadership of external partners. Areas of focus will include project management, supplier management, change management, leading business reviews, and support of regulatory filings. Extensive collaboration with internal and external customers is required.

Responsibilities:

• Management of CMO’s and critical suppliers; including budget planning, tracking, contracts, and manufacturing tactical execution.
• Establish and foster strong collaborative relationships with external manufacturing partners and service providers.
• Responsible for developing manufacturing service and supply agreements in close collaboration with Legal, Finance, Procurement, and Quality.
• Ensure safe and compliant cGMP operations.
• Establish and maintain detailed project plans; define risks and recommend contingency plans.
• Align external manufacturing schedules with demand forecast requirements.
• Ensure product delivery and supply plan is on time and within budget.
• Resource planning, generating metrics/ KPIs, and presentation of materials for internal stakeholder review.
• Change owner for manufacturing vendor change notifications; lead or assist with manufacturing deviations, customer complaints, and product failure investigations.
• Travel for in-person interactions with multiple contract manufacturing entities to ensure production is on plan. 10%
• On-site presence (Cambridge MA) preferred 30%
• Supports the development of outsourcing models, vendor evaluation, and CMO selection in close collaboration with key internal stakeholders.
• Perform other related duties and ad hoc projects as required by position.

Qualifications:

• Bachelor of Science and 8+ years experience in biologics manufacturing required.
• 3+ years experience in a management or technical MSAT position in clinical commercial manufacturing.
• Cell and Gene Therapy experience preferred
• Technical understanding of gRNA, mRNA, pDNA
• Fill finish experience
• Experience developing and maintaining manufacturing operations and quality systems required.
• Experience with managing contract manufacturing organizations required.
• Experience in commercial manufacturing, supply chain handling, clinical manufacturing and distribution.
• Knowledge of cGMP requirements is a must.
• Strong leadership skills with a track record of delivering new products to clinic with external partners.
• Strong communication skills (written and verbal), including experience presenting in front of multidisciplinary stakeholders.