Principal Research Scientist I CMC Sciences
Principal Research Scientist I CMC Sciences
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Not Disclosed
Salary Not Disclosed
1 Vacancy
Job Description
As the ADC CMC lead for clinical/commercial programs this position will be responsible for supporting regulatory approval of antibody drug conjugates and commercial support by leading technical teams throughout latephase and commercial development authoring/reviewing Chemistry Manufacturing and Controls (CMC) filing content and onmarket support such as troubleshooting global expansion sitetransfers and continuous improvement efforts.
Responsibilities:
- Accountable for driving CMC development plans in collaboration with technical functions and in alignment with overall program objectives.
- Ensures technical rigor and is accountable for team performance and technical deliverables of the project.
- Leads technical issue resolution and implements robust solutions that are aligned crossfunctionally.
- Ensures phase appropriate control strategy based on timelines and project risks.
- Schedules technical team meetings develops agendas issues program highlights and drives project timelines to ensure successful process development and regulatory submission.
- Works with the functional area leads to assemble content for technical reviews.
- Apprises CMC and PDS&T management of plans and risks through regular communications and periodic reviews throughout development.
- Responsible for the preparation and review of regulatory filings. Responds to urgent regulatory queries.
- Serves as spokesperson for the CMC project team on crossfunctional product teams and ensures information flow among line functions.
- Manages projects utilizing a matrix management approach.
Qualifications :
- Bachelors degree with at least 14 years of relevant experience (CMC small molecule mAb and/or ADC manufacturing/development); Masters Degree with at least 12 years of relevant experience; or PhD with at least 6 years of relevant experience.
- Demonstrated knowledge of regulatory requirements and strong technical knowledge of small molecule/mAb process and analytical development from early development through commercialization including process characterization studies process scaleup and technology transfer.
- Must demonstrate excellent scientific writing and verbal communication skills including experience authoring technical and regulatory documentation.
- Prior experience must include leadership in technical roles and demonstrated ability of problem solving on difficult technical problems.
- Prior experience working in highly matrixed teams and demonstrated leadership skills to influence and guide teams in achieving CMC deliverables while balancing scientific quality and compliance requirements.
- Strong project management skills with ability to manage multiple programs.
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 serving our community and embracing diversity and inclusion. It is AbbVies policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race color religion national origin age sex (including pregnancy) physical or mental disability medical condition genetic information gender identity or expression sexual orientation marital status status as a protected veteran or any other legally protected group status.
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No
Employment Type :
Fulltime
Employment Type
Full-time
