Associate Director Program Management CMC Biologics On-site
Associate Director Program Management CMC Biologics On-site
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Salary Not Disclosed
1 Vacancy
Job Description
Position will be responsible for ownership of digital systems and data management
strategies for biologics drug substance within Product Development Science and
Technology.
Responsibilities:
Lead implementation of work processes to eliminate manual data manipulation and
drive efficiencies in data aggregation/visualization with the aim of streamlining
IND/BLA authoring. This includes but is not limited to:
o Partner closely with process scientists engineers and statisticians to define
data flows within the CMC organization.
o Partner closely with Abbvie Business Data Systems/IT to deploy new digital
systems.
o Partner closely with Quality Assurance to ensure Biologics CMC data integrity
practices are best in class.
Serve as business area owner for various data and lab systems (eg PI NuGenesis
IDBS)
Interactions with regulatory authorities (FDA EMA) may be required.
Stay current with industry best practices and benchmark against Abbvie peer
companies
Qualifications :
- B.S. M.S. and/or Ph.D. in biochemistry biology chemical engineering computer engineering/science data science or related field with 10 years of industrial experience. Experience in biotechnology or biopharmaceutical development is preferred.
- Very strong writing presentation and communications skills are required.
- Significant technical understanding of biologics manufacturing as well as associated quality and analytical issues is required.
- Ability to work in a highly matrixed team and to influence scientists and SMEs in other disciplines is required.
- Ability to work against tight timelines to meet business goals.
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 shortterm incentive programs.
This job is eligible to participate in our longterm 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 :
Fulltime
Employment Type
Full-time
