Principal Research Scientist I, Plasmid Production Full-time

Job Title

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience – and products and services in our Allergan Aesthetics portfolio.

Job Description

Our group, as part of the Targeted Lipid Nanoparticle (tLNP) CMC team (TCT), collaborates across biologics discovery, CMC partners, Clinical Operations, Regulatory Affairs, Quality Assurance, and external manufacturing to advance tLNP assets from preclinical stages through key clinical milestones. Our priorities include establishing robust production processes in mammalian and microbial systems with our external partners, overseeing technology transfer and vendor management, reviewing critical technical documentation, and ensuring compliance with ICH guidelines and GMP standards. Purpose: We are seeking an experienced scientific professional to lead the management of external projects with vendors, primarily in DNA plasmid production in microbial systems. The successful candidate will have a strong background in upstream culture or downstream purification process development, and will demonstrate proven project management skills, ideally with experience performing tech transfers between vendors and managing external vendors.

Responsibilities:

1. Serve as the lead and provide support for one or more plasmid production Chemistry, Manufacturing, and Controls (CMC) projects, guiding cross-functional teams from planning through execution in a matrix environment.
2. Manage external vendor project execution to ensure quality, efficiency, timeliness, and adherence to budget and company objectives.
3. Review and assess technical documents such as master batch records, executed batch records, and related GMP documentation to ensure compliance, accuracy, and alignment with regulatory standards and project objectives
4. Apply scientific expertise to supervise and troubleshoot upstream and/or downstream processes in DNA plasmid production.
5. Proactively identify project risks and challenges, proposing innovative solutions and strategies.
6. Coordinate and facilitate communication among internal stakeholders and external partners/vendors.
7. Utilize strategic thinking and process development experience to optimize project outcomes.
8. The position may require occasional travel to vendor sites or conferences, depending on project needs.

Qualifications

• BS or equivalent education and extensive, typically 14+ years of experience; MS or equivalent education with typically 12+ years of experience; PhD with typically 6+ years of industry experience in area or scientific area of discipline.
• Strong scientific background in plasmid production in microbial systems (such as E. coli or other bacterial hosts).
• Hands-on experience with upstream culture and/or downstream plasmid purification.
• Demonstrated project management experience; PMP or similar certification preferred.
• Experience with external vendor management and technology transfer is highly desirable.
• Familiarity with ICH guidelines, GMP compliance, or other regulatory aspects relevant to CMC is required.
• Excellent organizational, communication, and stakeholder management skills.
• Ability to thrive in a cross-functional, matrixed environment and drive results through collaboration.
• Previous CMC project leadership experience is considered a plus
• This role requires strong attention to detail and the ability to balance multiple complex projects simultaneously.

Additional Information

The compensation range described below is the range of possible base pay compensation that the Company believes in good faith it will pay for this role at the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on many factors including geographic location, and we may ultimately pay more or less than the posted range. This range may be modified in the future. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick), medical/dental/vision insurance and 401(k) to eligible employees.

AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled.

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Where We Work

Role is primarily site- or office-based but can occasionally be performed remotely. Employees who are site/office-based and can occasionally perform their role virtually work both in the office and remotely*, following the policies and regulations in place at their location. US Employees must be in the office on Tuesday, Wednesday, and Thursday with flexibility to work remotely on Mondays and Fridays. Three days in the office is the minimum; some individuals or teams may require more in-office days due to meetings, business/project needs or their role.