Principal Research Scientist I, CMC Sciences Biologics Development and Launch (BDL)

AbbVie Inc; Boston (MA); On-site; USD 106,000 - 203,000; Full time

Job summary

A leading company in the healthcare sector is seeking an experienced mAb lead for clinical programs to spearhead regulatory approvals of biologics. The role demands strong project management and technical problem-solving skills while collaborating with matrixed teams to deliver quality results. Candidates should possess significant industry experience and a robust understanding of biologics processes.

Benefits

Comprehensive benefits package including medical, dental, and vision insurance.

401(k) plan with company matching.

Participation in incentive programs.

Paid time off including vacation and holidays.

Qualifications

• At least 6 years of relevant experience for PhD, 12 years for Master's, or 14 years for Bachelor's.
• Demonstrated knowledge of regulatory requirements for biologics.
• Experience in leadership roles on technical issues.

Responsibilities

• Drive CMC development plans in collaboration with technical functions.
• Lead technical issue resolution and ensure project timelines.
• Prepare and review regulatory filings, respond to queries.

Skills

Scientific writing

Verbal communication

Technical problem solving

Project management

Education

PhD in relevant field

Master's Degree in relevant field

Bachelor's degree in relevant field

Job description

Company Description

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us atwww.abbvie.com. Follow @abbvie onX,Facebook,Instagram,YouTube,LinkedInandTik Tok.

Job Description

Purpose:

As 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.

Qualifications

• 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.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law:

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. Salary: $106,500-$202,500

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible to participate in our short-term incentiveprograms.

• This job is eligible to participate in our long-term incentiveprograms

Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable 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.

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