The Global Drug Development (GDD) organization oversees the development of new medicines discovered by our researchers and partners. We transform the lives of people by developing innovative and life-changing medicines.
The Associate Director position- (Upstream, Drug Substance, Technical Research and Development), is responsible for the execution and management of process development activities in Gene Therapy at Novartis. Gene Therapies are a fast growing and exciting area of next generation medicines where our knowledge and impact are advancing rapidly. Our team has a large pipeline of innovative viral vector therapies and needs top talent to join our effort to develop molecules for clinical use to improve outcomes for many of our patients. We are looking for a candidate that seeks collaboration with their peers, values teamwork and can thrive in a multisite/multidisciplinary team of highly effective and focused scientists.
Your Key Responsibilities:
•Serving as a key scientific and technical representative for Upstream processing at internal sites, meetings and with external partners.
•Leads a diverse team of Upstream processing scientists in the technical R&D laboratory to deliver processes in support of new pipeline gene therapies.
•Builds and maintains a high performing staff of engineers and scientists to support ongoing process and pipeline development as well as process transfers to internal and external manufacturing sites.
•Work cross-functionally to obtain feedback and alignment regarding projects and potential modifications to current processes.
•Supports and develops the next generation manufacturing processes by planning to avoid delays, managing resources and leading activities to deliver a robust and effective product and process.
•Partners with Clinical, Manufacturing and Research to assure our process design supports safe and effective delivery to the patients.
•Partners with Regulatory and program leads to support submissions and approval of product applications.
•Reviews and provides feedback and technical/scientific support on project deliverables, (e.g. remediation initiatives, plan reports). Ensures all documentation and reports are accurate, complete, and suitable for using in support of development, characterization, and regulatory approval of products.
•Partners with Project Managers, Strategy Teams, Engineering, Supply Chain and others to anticipate and plan for budget and capex cycles, human and materials resourcing.
Minimum requirements
What you’ll bring to the role:
•A combination of applicable technical experience, education, and proven leadership capabilities may be used to qualify for the level of this role. Bachelors’ degree in Biology, Biochemistry, Chemical engineering, Bioengineering, or related technical field with 11 years of experience in biopharmaceuticals; Master’s degree with 9 years or PhD with 7 years.
•Excellent oral and written communication skills; attention to detail.
•11 years direct experience in cell culture, recovery, purification, analytics, and/or aseptic fill/finish processes, process development, and tech transfer.
•Familiar with global health authority regulations, regulatory filings, validation/qualification requirements.
•Strong organizational skills and ability to multitask across projects and activities.
•Proven ability to effectively lead and participate on teams.
•7 years leadership experience.
•Up to 10% travel required at times.
Desirable requirements:
•Experience with AAV and lentiviral vector process development.
•Proven ability to lead scientific project teams and influence others with and without direct line authority.
•A collaborative nature with the mindset that we succeed together.
The pay range for this position at commencement of employment is expected to be between $151,200 and $226,800/year; however, base pay offered may vary depending on multiple individualized factors, including market location, job-related knowledge, skills, and experience. The total compensation package for this position may also include other elements, including a sign-on bonus, restricted stock units, and discretionary awards in addition to a full range of medical, financial, and/or other benefits (including 401(k) eligibility and various paid time off benefits, such as vacation, sick time, and parental leave), dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment. If hired, employee will be in an “at-will position” and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time, including for reasons related to individual performance, Company or individual department/team performance, and market factors.
Why Novartis?
236 million lives were touched by Novartis medicines in 2022, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what’s possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying!
Imagine what you could do here at Novartis!
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.
Accessibility and reasonable accommodations
The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or in order to perform the essential functions of a position, please send an e-mail to [email protected] call +1 (877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
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