Senior Expert, Science & Technology (Analytical Project Lead)

Novartis • Durham, NC

273d • $114,100 - $211,900

About The Position

The Analytical Development Operations (ADO) group is responsible for developing analytical technologies and applying them to support viral vector development for cell and gene therapies. ADO supports chemistry, manufacturing and control (CMC) activities from the earliest stages of product candidacy through commercial licensure. Within ADO, the Senior Expert, Science & Technology, Analytical Project Lead (APL) APL is responsible for identifying critical quality attributes (CQA) of a viral vector candidate and developing analytical strategies and methods for monitoring CQAs throughout product development. The APL works within a cross functional CMC team to design, coordinate, and execute studies that demonstrate Novartis understands and appropriately controls the quality of our product and process. This APL position offers the opportunity to develop and apply rapidly advancing analytical technologies necessary to ensure Novartis consistently delivers safe and effective cell and gene therapeutics.

Requirements

• BS/BA in relevant field with 8 years', MS with 6 years', or Ph.D. with 4 years' experience in biopharmaceutical industry
• A critical thinking mindset, problem-solving skills, and the interpersonal communication, scientific writing, and presentation abilities to provide effective leadership
• Strong organizational skills and ability to prioritize simultaneous projects and activities
• Proven ability to effectively lead and participate on teams, often via tele/video conference
• Passion for continuous learning and capability to work in a highly dynamic, fast-paced, collaborative environment is key to the success of this role.
• Experience with analytical support for biologic product commercialization, especially in cell/gene therapy field
• Strong background in protein/nucleic acid chemistry/biochemistry/analytical chemistry
• Experience preparing regulatory filings and other correspondence/interactions with regulatory agencies

Nice To Haves

• Project management experience
• Familiarity with GMP practices and requirements (e.g. change control) and regulations (FDA/EMA/ICH etc.)

Responsibilities

• Produce product CQA assessment, analytical strategy, specifications, and comparability strategies/criteria
• Lead the development, qualification, transfer, and validation of analytical methods among multiple internal and external analytical laboratories
• Facilitate forecasting and allocation of internal analytical resources
• Manage scope, timelines, and budget activities with external analytical laboratories
• Lead cross-functional and cross-site product characterization and investigations
• Provide technical expertise and leadership as you collaborate within and across cross-functional teams to support process development and establish control strategy
• Provide strategic recommendations across the network
• Serve as a key scientific and technical representative on cross-functional teams (CMC, Regulatory, Quality, Manufacturing, etc.)
• Write, review, and/or approve experimental protocols/reports and regulatory submissions
• Respond to questions from regulatory authorities regarding analytical topics and specifications

Benefits

• 401(k) eligibility
• Various paid time off benefits, such as vacation, sick time, and parental leave
• Sign-on bonus
• Restricted stock units
• Discretionary awards
• Full range of medical and financial benefits

What This Job Offers

• Job Type: Full-time
• Career Level: Senior
• Industry: Chemical Manufacturing
• Education Level: Master's degree