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:
The Associate Director of Manufacturing Operations will support cGMP activities at the Durham North Carolina Site. This position will oversee a group of Manufacturing Specialists that support GMP operations for all compliance related activities. This includes ownership of all deviations, CAPAs, change controls and the strategic decisions that drive these events. The position will be critical to the overall production strategy and operational readiness of the manufacturing organization for Beam as the company grows and evolves from a Research and Discovery company to a broader organization, moving products through the clinical pipeline to commercial launch and growth. This position will support manufacturing management and teams for all start up and production related activities, acting as an area SME (subject matter experts).Support and advise the Manufacturing team leadership as needed. The candidate will work with cross-functional teams to identify and implement meaningful corrective actions arising from deviations and audit observations. This position will also support Beam’s internal groups across the company where manufacturing operations support is required. Work closely with the Director of Manufacturing to shape the specialist organization for sustainable performance and operation in harmony with Manufacturing.
Responsibilities:
- Supervise, organize, coach, develop a small team of Manufacturing Specialists and SMEs (subject matter experts). Work in parallel on any compliance related activities as an author, contributor as needed.
- Provide support for all related start up and continuous production activities related to operational readiness including, but not limited to procedure creation, equipment qualification and validation
- Participate as manufacturing representative on all new product introduction or tech transfer projects
- Initiate and drive to completion deviations, change controls and CAPAs for appropriateness, completeness and to meet internal procedures and regulatory expectations.
- Work collaboratively with cross functional teams, partners, and vendors to gather background knowledge needed to complete assignments.
- Provides manufacturing and operational guidance and recommendations in a professional and collaborative manner to internal and external stakeholders.
- Drafts and reviews SOPs (Standard Operating Procedure) and related GMP documents as needed.
- Provide operational support and guidance as needed to contract manufacturing operations (attend meetings, person in plant review and approval of CMO (Contract Manufacturing Organization) documentation.)
- Monitors and trends batch record errors, provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error.
- Applies strong technical expertise of MFG/QA processes to support development and maintenance of cGMP compliant quality performance.
- Provides consistently prompt, efficient, dependable, highly skilled service.
- Demonstrates consistent judgment, quality, accuracy, speed, and creativity.
- Detects and resolves problems; assists others with problem resolution; misjudgment may jeopardize compliance.
- Understands, selects, and uses appropriate risk management and root cause analysis tools.
- Takes initiative in making improvement suggestions to promote operational goals.
- Applies Quality concepts and company policies to resolve issues of moderate complexity in an effective manner.
- Reflects solid understanding of strategies and goals and can take part in major parts of projects or provide expert service.
- Recommends improvements to on-going processes and projects.
- Facilitates designing processes with Quality built in from the beginning.
- Identifies and uses good judgement to handle out-of-compliance situations.
Qualifications:
- Knowledge of science attained through studies resulting in a B.S. in science, engineering, biochemistry or related discipline, or its equivalent is preferred with 12 + years of relevant experience in a GMP environment
- Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, analytical testing is strongly preferred.
- Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
- Must have experience in drafting and reviewing technical documents with high technical writing skill.
- Working knowledge of validation and related concepts.
- Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed
- Able to independently troubleshoot problems and issues; called upon to train or assist others for a large portion of the job.
- Proficient in Microsoft Word, Excel, Power Point, and other applications. Preferred knowledge of Veeva QMS.
- Good listening and communication skills.
- Positive approach and highly collaborative persona.
