About AbbVie
AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas including immunology, oncology and neuroscience - and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on LinkedIn, Facebook, Instagram, X and YouTube.
Job DescriptionAs the mAb lead for clinical programs, this position will be responsible for supporting regulatory approval of biologics drug substances by leading technical teams throughout Phase 1, Phase 2, and Phase 3 development and authoring Chemistry, Manufacturing, and Controls (CMC) filing content.
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 cross-functionally.
- 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 drug substance CMC project team on cross-functional product teams and ensures information flow among line functions.
- Manages projects utilizing a matrix management approach.
- Bachelor’s degree with at least 14 years of relevant experience; Master’s 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 biologics process and analytical development from early development through commercialization including process characterization studies, process scale-up, 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.
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 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 Company's sole and absolute discretion unless and until paid and may be modified at the Company’s 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 https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html
US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:
https://www.abbvie.com/join-us/reasonable-accommodations.html
Skills Required
- Bachelor's degree with at least 14 years of relevant experience; Master's with 12 years; or PhD with 6 years.
- Strong technical knowledge of biologics process and analytical development from early development through commercialization.
- Demonstrated knowledge of regulatory requirements and experience preparing regulatory filings and responding to regulatory queries.
- Experience authoring technical and regulatory documentation with excellent scientific writing and verbal communication skills.
- Proven leadership in technical roles with demonstrated problem solving on difficult technical problems.
- Prior experience working in highly matrixed teams and ability to influence and guide cross-functional teams to achieve CMC deliverables.
- Strong project management skills and ability to manage multiple programs.
AbbVie Compensation & Benefits Highlights
The following summarizes recurring compensation and benefits themes identified from responses generated by popular LLMs to common candidate questions about AbbVie and has not been reviewed or approved by AbbVie.
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Retirement Support — 401(k) contributions include a dollar-for-dollar match up to 6% plus an additional annual company contribution tied to age and service. Company-paid life insurance and other financial protections further strengthen long-term security.
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Parental & Family Support — Paid leave programs include up to 12 weeks at 100% for parental leave and separate paid caregiver leave, with eligibility after six months where noted. Adoption and surrogacy reimbursements and family-building resources add further support.
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Healthcare Strength — Health coverage begins on day one with medical, dental, vision, mental health, and prescription benefits, and preventive care covered at 100%. Options such as HSAs/FSAs and coverage for spouses/domestic partners and children up to age 26 broaden accessibility.
AbbVie Insights
What We Do
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, neuroscience, eye care, aesthetics and other areas of unmet need.
