Principal Scientist I, Biologics Analytical Research and Development

BioSpace

San Francisco (CA)

On-site

USD 140,000 - 210,000

Full time

21 hours ago

Be an early applicant

Application generator

Stand out for this role — generate a tailored resume and cover letter in about a minute.

Get past ATS filters

Job summary

AbbVie Biologics ARD in the Bay Area is seeking a highly skilled analytical scientist to lead development of advanced methods for biotherapeutic protein characterization. The role includes independent method development, cross-functional leadership on CMC development teams, and mentoring junior scientists at an on-site South San Francisco facility.

The successful candidate will drive regulatory strategy, contribute to submissions, and advance QC method qualification and transfer, with

Qualifications

Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field.
PhD with 6+ years, MS with 12+ years, or BS with 14+ years of relevant industry experience.
Solid understanding of protein chemistry and biochemistry in biotherapeutic drug development.
Analytical method development experience for biologics, capillary electrophoresis and HPLC.
Experience with biologics CMC development, QC method qualification/validation, and method transfer.
Experience contributing to regulatory submissions and health authority responses.
Strong leadership, communication, and collaboration skills with mentoring experience.

Responsibilities

Independently develop state-of-the-art capillary electrophoresis and chromatographic methods for biotherapeutic proteins.
Generate scientific proposals and innovative analytical approaches to solve challenges.
Represent Analytical Lead on CMC development teams and cross-functional projects.
Supervise one or more scientists and manage team performance.
Develop/qualify/validate and transfer QC release and stability methods; oversee QC testing at GMP labs.
Plan, author, and review regulatory submission documents and technical reports.
Engage with the scientific community through publications, posters, and conferences.

Skills

Protein chemistry

Analytical method development

Capillary electrophoresis

HPLC

Regulatory submissions

Data interpretation

Leadership

Mentoring scientists

Scientific publications

Project management

Education

PhD with 6+ years

MS with 12+ years

BS with 14+ years

Job description

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 atwww.abbvie.com. Follow @abbvie onLinkedIn,Facebook,Instagram,XandYouTube.

Company Description

About AbbVie

Job Description

About the Team

AbbVie Biologics Analytical Research & Development (Biologics ARD) is a global analytical sciences organization responsible for CMC analytical development of AbbVie's pipeline of innovative therapeutic biologic products. We are a world-class team of scientists and leaders united by a shared mission to advance industry-leading analytical capabilities and meaningfully contribute to the advancement of AbbVies pipeline of innovative medicines.

The Biologics ARD team at the AbbVie Bay Area site in South San Francisco has a long and rich history of biologics development. Located in a state-of-the-art facility housing end-to-end CMC development capabilities, the team works collaboratively to advance novel biologic therapeutics including multi-specifics, ADCs, antibodies, and novel modalities into first-in-human clinical development and through to clinical proof of concept. Careers in AbbVie Biologics ARD provide unique opportunities to work with cross-functional and global teams to drive exceptional science and innovative product development strategies.

Role Summary

We are seeking a highly skilled and motivated analytical scientist to join the Biologics CMC Analytical Research and Development team. This role provides scientific leadership in the development of advanced analytical methods to support biotherapeutic protein characterization, process understanding, and product development. The successful candidate will independently develop innovative approaches and apply state-of-the-art capillary electrophoresis and chromatographic methods, serve as an analytical lead on development teams, and contribute to regulatory strategy and scientific innovation. This position also includes supervisory responsibilities, including leading and mentoring one or more scientists and supporting their performance and development. The role operates within a cross-functional, on-site environment supporting a portfolio that includes multi-specifics, antibodies, ADCs, and novel modalities.

Responsibilities

Independently develop state-of-the-art capillary electrophoresis and chromatographic methods to characterize biotherapeutic proteins and their associated variants and impurities.
Generate new scientific proposals and develop innovative approaches to solve difficult analytical challenges.
Represent the Biologics CMC Analytical Research and Development Group as Analytical Lead on CMC development teams and a subject matter expert on cross functional project teams.
Supervise a team of one or more scientists and be accountable for the effective performance of the team.
Develop/optimize, qualify/validate, and transfer fit-for-purpose QC release and stability methods. Provide technical support and oversight for QC testing occurring at internal and external GMP laboratories.
Plan, author, and review regulatory submission documents, responses to health authority queries, technical reports, lab data, and method qualification/validation protocols.
Engage and influence the broader scientific community through publications and poster and oral presentations at industry conferences.

Qualifications

Degree in Chemistry, Biochemistry, Analytical Chemistry, or a related field. PhD with 6+ years, MS with 12+ years, or BS with 14+ years of relevant industry experience.
Must possess a solid understanding of protein chemistry and biochemistry, particularly as it relates to biotherapeutic protein drug development.
Demonstrated expertise in analytical method development for biologics, with strong hands‑on experience in capillary electrophoresis and HPLC.
Experience supporting biologics CMC development, QC method qualification/validation, and method transfer.
Proven ability to interpret complex data, solve technical problems, and propose innovative scientific solutions.
Experience contributing to regulatory submissions, including quality and characterization sections, and responding to health authority questions.
Strong leadership, communication, and collaboration skills, with experience mentoring and supervising scientists.
Track record of scientific publications and conference presentations preferred.
Must be capable of working in a fast‑paced, collaborative environment and managing multiple concurrent projects with a high degree of independence.

Preferred Attributes

Deep understanding of biologics analytics, impurity profiling, and protein characterization.
Ability to work effectively across functions and influence scientific and technical decisions.
Strong organizational skills and the ability to manage multiple priorities in a fast‑paced environment.
Commitment to scientific excellence, quality, and continuous improvement.

This is a full-time, on-site role located in South San Francisco, CA. The position requires daily in‑person collaboration across scientific and cross‑functional teams. Candidates should expect frequent interaction with both local and global colleagues.

Compensation & Leveling

Compensation and Leveling will be commensurate with experience.

Additional Information

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, andwemayultimatelypaymore or less than the posted range. This range may bemodifiedin thefuture.
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 toparticipatein 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 employeeremains in the Company's sole and absolute discretion unless and until paid andmay bemodifiedat the Companys 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.

US & Puerto Rico only - to learn more, visithttps://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

Get your free, confidential resume review.

or drag and drop your file here.