Position Overview:

The Manufacturing Specialist will support cGMP activities at the Durham North Carolina Site. The Manufacturing Specialist will have responsibility to assure initiatives related to production readiness and compliance are optimized and executed appropriately in the areas of GMP production. This position will support manufacturing management and teams for all production-related activities. 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.

Primary Responsibilities:

• Provide support for all related start-up and continuous improvement activities related to operational readiness and operational excellence, including procedure creation, revision, equipment qualification and validation.
• 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 and related GMP documents.
• Provide operational support and guidance as needed to contract manufacturing operations (attend meetings, person in plant review and approval of CMO documentation.)
• Provides on the floor support, including participating in daily GMP manufacturing activities.
• Monitors and trends batch record errors, provides management with quality indicator data, and collaborates with stakeholders to reduce sources of error. Participates in batch record review and completion.
• Applies strong technical expertise of MFG/QA processes to support development and maintenance of cGMP compliant quality performance.
• Develop proficiency with site scheduling tools to input direct updates to the Plant Finite Schedule as well as coordination of cross-functional activities. Serve as a back-up for site scheduling as needed.

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 5-8+ years of relevant experience in a GMP environment. Final level/title will be commensurate with experience.
• Knowledge of aseptic processing/cell culture/cell and gene therapy manufacturing, analytical testing is strongly preferred.
• Must be able to work onsite daily. Must be willing to have a flexible schedule to support a multi-shift operation that covers nights and weekends as needed.
• Travel for in-person interactions with cross-functional stakeholders to ensure tech transfer is on track as needed.
• Proficient in Microsoft Word, Excel, Power Point, and other applications.
• Working knowledge of validation and related concepts.
• Must have experience in drafting and reviewing technical documents with high technical writing skill.
• Independently troubleshoots problems and issues; called upon to train or assist others for a substantial portion of the job.
• 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.
• Good listening and communication skills.
• Positive approach and highly collaborative persona.