Associate Director, tLNP Formulation
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Job Location:
North Chicago, IL - USA
Monthly Salary:
Not Disclosed
Posted on:
5 hours ago
Vacancies:
1 Vacancy
Job Summary
We are seeking a leader responsible for the oversight of formulation development sterile fill-finish process development scale-up tech transfer and manufacture of targeted lipid nanoparticles (tLNPs) for pre-clinical and clinical studies. The successful candidate should demonstrate his/her ability in establishing and leading a growing formulation team and will work seamlessly with external manufacturing organizations to complete GMP testing. In addition the incumbent will be expected to establish systems in the department to enable manufacturing of the batches for non-clinical safety studies and clinical studies under GMP. The candidate will oversee work on a cross-functional product development team including liaising with Biologics CMC Synthetic Molecule CMC Clinical Operations Regulatory Affairs including addressing requests for Health Authorities and Quality Assurance in development and commercialization of drug products.
Responsibilities:
- Responsible for overseeing formulation development of targeted lipid nanoparticles (tLNPs) entering FIH as well as formulation optimization and commercial formulation definition prior to pivotal clinical trials.
- Responsible for evaluation of novel product presentations for tLNPs which may include a lyophile spray dried powder nonaqueous suspension or other advanced presentations and the process development thereof.
- Designs oversees and reviews clinical in-use studies to evaluate the stability and compatibility of tLNP drug products.
- Manages contract development and manufacturing organizations (CDMOs) involved in sterile fill finish operations of tLNPs.
- Reviews and approves documents related to formulation development and drug product production including technical transfer process development reports qualifications master and executed batch records and campaign summary report.
- Works closely with others in CMC and quality assurance to lead investigations and data analysis to address deviations/non-conformance and implement change controls to ensure timely/prompt release of batches.
- Authors and reviews drug product sections for regulatory submissions.
- Contributes to the development and monitoring of departmental goals and budgets.
Qualifications :
- Chemistry Molecular Biology Chemical or Bioengineering and 8 years of related experience or MS/BS with 14/16 years of related experience
- Extensive experience working with protein therapeutics antibodies conjugation chemistries and genetic medicines including LNPs
- Experience with process development analytical characterization process scale-up and/ or regulatory descriptions of drug product manufacturing processes/registration
- Experience with project management with external partners
- Experience with GxP/ GMP production
- Familiarity with quality by design late-stage PD and process characterization preferred.
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 postingbased 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 paymore 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 commissionincentive 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 untilpaid 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
- Program assessment
- FDA Regulations
- Manufacturing & Controls
- Program Evaluation
- budget forecast
- Research Experience
- Operations Management
- Research & Development
- Strategic Planning
- Contract Management
- Leadership Experience
- negotiation
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
