Senior Scientist II CMC Sciences Biologics Development and Launch BDL -Remote Role
Senior Scientist II CMC Sciences Biologics Development and Launch BDL -Remote Role
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
Purpose:
Support regulatory approval of biologics drug substances by authoring Chemistry Manufacturing and Controls (CMC) filing content and by leading crossfunctional CMC teams throughout Phase 1 Phase 2 and Phase 3 development
Responsibilities:
- Author sections of regulatory documents including INDs and BLAs based on relevant source documentation.
- Partner with subject matter experts in various process development functions to ensure technical information is accurately transcribed into regulatory documents.
- Lead CMC teams in the development of robust control strategies and presentation of Control Strategy Reviews (CSRs)
- Drive alignment with key business stakeholders including Product Development Directors Development Sciences and Quality Assurance and escalate issues to senior management when appropriate
- Contribute on program acceleration and increased efficiency initiatives.
Qualifications :
- BS or equivalent education in Biology Biochemistry Engineering or related discipline and 8 years of experience in the biopharmaceutical industry; MS and 6 years experience; PhD and 3 years experience.
- Demonstrated knowledge of biologics manufacturing processes including cell culture and purification operations and knowledge of process development.
- Demonstrated knowledge of Good Documentation Practices (GDP) and technical writing.
- Demonstrated knowledge of scientific and regulatory requirements for biopharmaceutical products.
- High proficiency with Microsoft Word and Excel.
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
