Associate Director, Program Management CMC Biologics

Boston, NH - USA

Monthly Salary: Not Disclosed

Posted on: 30+ days ago

Vacancies: 1 Vacancy

Job Summary

Purpose:

The Associate Director will be fully accountable for providing CMC leadership to both commercial and development projects with a focus on biologics drug substance. This role serves as a central leader within the Biologics Development and Launch (BDL) group.

Responsibilities:

Develop comprehensive project plans budgets timelines and strategy; biologics projects at all stages of development are included from phase I through commercial.
Must present technical information regarding biologics manufacturing process development and process characterization to management and to regulatory agencies.
Prepare and review regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.
Manage multiple projects at various stages of development.
Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team (PPDST) and collaborate with stakeholders including R&D RA and Operations (MES QA sites Supply Chain purchasing etc.).
Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.

Qualifications :

Ph.D. in biochemistry biochemical engineering cell biology or related field with 8 years of industrial experience (or equivalent) is required.
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.
Experience in biologics manufacturing process support and/or development analytical development or biologics process validation is needed.

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.
This job is eligible to participate in our long-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:

Work :

Yes

Employment Type :

Full-time

Purpose:The Associate Director will be fully accountable for providing CMC leadership to both commercial and development projects with a focus on biologics drug substance. This role serves as a central leader within the Biologics Development and Launch (BDL) group.Responsibilities:Develop comprehens...

Purpose:

Responsibilities:

Develop comprehensive project plans budgets timelines and strategy; biologics projects at all stages of development are included from phase I through commercial.
Must present technical information regarding biologics manufacturing process development and process characterization to management and to regulatory agencies.
Prepare and review regulatory briefings and submissions to support clinical trials through registration of the product as well as post-approval life-cycle management.
Manage multiple projects at various stages of development.
Represent assigned projects on the multidisciplinary Product Presentation and Device Strategy Team (PPDST) and collaborate with stakeholders including R&D RA and Operations (MES QA sites Supply Chain purchasing etc.).
Participate in or lead/coordinate Governance efforts such as Product Performance Teams or gate reviews.

Qualifications :

Ph.D. in biochemistry biochemical engineering cell biology or related field with 8 years of industrial experience (or equivalent) is required.
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.
Experience in biologics manufacturing process support and/or development analytical development or biologics process validation is needed.

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.
This job is eligible to participate in our long-term incentive programs

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:

Work :

Yes

Employment Type :

Full-time

Key Skills

Nurse Management
Program Management
Employee Evaluation
Management Experience
Teaching
Curriculum Development
Administrative Experience
Budgeting
Leadership Experience
Program Development
Supervising Experience
Addiction Counseling

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About Company

AbbVie

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

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