Principal Research Scientist I, Plasmid Production
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
4 hours ago
Vacancies:
1 Vacancy
Job Summary
About the Team: 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. Through strategic management of external projects and the application of scientific innovation to process execution we proactively mitigate risks and consistently deliver high-quality drug product components in support of the companys tLNP pipeline and commercial goals.
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:
- 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.
- Manage external vendor project execution to ensure quality efficiency timeliness and adherence to budget and company objectives.
- 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
- Apply scientific expertise to supervise and troubleshoot upstream and/or downstream processes in DNA plasmid production.
- Proactively identify project risks and challenges proposing innovative solutions and strategies.
- Coordinate and facilitate communication among internal stakeholders and external partners/vendors.
- Utilize strategic thinking and process development experience to optimize project outcomes.
- 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 :
Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:
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.
This job is eligible to participate in our short-term incentive programs.
Note: No amount of pay is considered to be wages or compensation until such amount is earned vested and determinable. The amount and availability of any bonus commission incentive benefits or any other form of compensation and benefits that are allocable to a particular employee remains in the Companys sole and absolute discretion unless and until paid and may be modified at the Companys sole and absolute discretion consistent with applicable law.
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.
US & Puerto Rico only - to learn more visit & Puerto Rico applicants seeking a reasonable accommodation click here to learn more:
No
Employment Type :
Full-time
Key Skills
- Machine Learning
- Python
- Data Science
- AI
- R
- Research Experience
- Sensors
- Drug Discovery
- Research & Development
- Natural Language Processing
- Data Analysis Skills
- Toxicology Experience
About Company
AbbVie is a global biopharmaceutical company focused on creating medicines and solutions that put impact first for patients, communities, and our world. We aim to address complex health issues and enhance people's lives through our core therapeutic areas: immunology, oncology, neuro ... View more
