Specialist, Manufacturing - Cell Expansion

Overview

Ready to join a team committed to developing and commercializing gene therapies for patients and families devastated by rare neurological genetic diseases? Since 2013, Novartis Gene Therapies (formerly AveXis) has had one focus: bringing change to those devastated by genetic diseases.

The Novartis Gene Therapies culture embraces this mission. As a compassionate and dedicated team, we are enthusiastic about the science behind our work and finding answers to difficult questions. We are dedicated to communities affected by rare diseases, and these patients and families are the motivation for everything we do.

We have built a team with exceptional depth of experience, unified by a common vision; to develop gene therapies with the potential to positively impact the lives of the patients and families devastated by rare and life-threatening neurological genetic diseases. Though we are proud of what we have achieved to date, we remain relentlessly focused on making that vision a reality.

The Manufacturing Specialist is responsible to support the primary manufacturing process owner and the manufacturing group by providing required process input to the engineering, validation, MSAT, maintenance, QC and QA groups at both the Durham and Libertyville manufacturing sites. The Manufacturing Specialist will be the owner of portions of the manufacturing process supporting the upstream, downstream, fill/finish, or manufacturing support groups. This individual will be required to ensure manufacturing process alignments between both manufacturing sites and may support new product introductions technology transfers into and out of the manufacturing site.

Responsibilities

• Support the manufacturing process owner (SME) for a portion of the manufacturing process (upstream, downstream, fill/finish, or manufacturing support).
• Ensures process alignment between the manufacturing sites through collaborative interactions with manufacturing, MSAT, QA/QC, and the supply chain functions at both production sites.
• Serve as a manufacturing document owner for certain production process steps.
• Own critical manufacturing deviation investigations and define pragmatic and effective CAPAs.
• Identify, develop and implement process robustness improvements through lean principals.
• Lead process specific training for the direct manufacturing group.
• Support internal and external audits for manufacturing process steps.
• Support the PMO group for any technology transfer activities.
• Own manufacturing process related change controls.
• Responsible for maintaining quality standards to meet GMP requirements, CFR's and internal company policies with respect to the manufacturing process.
• Responsible for providing manufacturing SME support on capital related projects.

Qualifications

• Minimum B.S. degree in Engineering or the life sciences and 5 years of work experience in biopharmaceutical based GMP manufacturing operations.
• Experience in the development of manufacturing documentation and in the investigation of complex manufacturing deviations.
• In-depth knowledge of FDA regulations and GMP systems and experience providing process support in a highly regulated or pharmaceutical / biotech facility.
• Applied knowledge of Quality by Design, six-sigma, and operational excellence tools in creating efficient and high-quality processes and end products.
• Excellent oral and written communication skills. Strong technical writing ability required.
• Travel as required to other internal sites, vendors, and CMOs as required (~20%).

The level of this position will be based on the final candidate's qualifications.

Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job. Duties, responsibilities and activities may change at any time with or without notice.

Novartis Gene Therapies is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, gender, gender identity, national origin, genetics, disability, age, sexual orientation or veteran status.

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