Scientist II, Biologics Drug Product Development
Notify me about similar jobsAbout this opportunity
Company 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 at www.abbvie.com . Follow @abbvie on LinkedIn, Facebook , Instagram , X and YouTube.
Job Description
The Drug Product Development group within AbbVie is a global organization responsible for developing and characterizing drug product formulations and manufacturing processes for biologic therapeutics (antibodies, multispecitics, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.
We have an exciting opportunity for a Scientist I/II to join our team at our Bay Area site in South San Francisco, CA. This role is an onsite role in a lab-based function and will focus on driving drug product development through formulation, process and in-use and will be the HPLC/UPLC technical lead and subject matter expert. This position is ideal for a scientist with experience in biologics formulation and characterization who is passionate about chromatography and eager to support the team as to ensure utility and maintenance of HPLC/UPLC instruments. To be successful, candidates must thrive in a highly collaborative laboratory environment with daily face-to-face interactions across multiple scientific disciplines.
KEY RESPONSIBILITIES INCLUDE:
Formulation & Biologics Drug Product Development
Independently lead and execute drug product development studies to support clinical studies, including formulation screening, in-use studies, and manufacturing process support.
Generate robust scientific data and documentation to support IND/NDA/BLA regulatory submissions, CTD module documentation, and technical reports.
Collaborate with cross-functional partners including Analytical Development and Drug Substance team to advance pipeline programs.
Develop scientific understanding of formulation attributes and product quality characteristics through hands-on laboratory experimentation and data interpretation.
Contribute to continuous improvement of formulation strategies and drug product processes, applying scientific rigor and innovation.
HPLC/UPLC Subject Matter Expertise
Serve as the primary technical resource and owner for HPLC/UPLC systems within the Drug Product Development group and implement a system to keep HPLC/UPLC instruments maintained, operational, and minimize downtime.
Lead troubleshooting and root-cause investigations for chromatographic instrumentation, methods, and data acquisition systems to maximize instrument uptime and laboratory productivity.
Coordinate instrument maintenance, qualification activities, and vendor support while ensuring compliance with laboratory procedures and quality requirements.
Act as an Empower software superuser by supporting users, troubleshooting data acquisition and processing issues, and promoting efficient data management practices using AbbVie data strategy tools.
Develop and deliver HPLC training curricula, maintain SOPs and training materials, and serve as a technical resource and scientific consultant on HPLC-related matters.
May provide guidance for HPLC/UPLC method adjustments to enable accelerated characterization of new molecules.
Scientific Contribution & Communication
Independently analyze, interpret, and document experimental data in electronic lab notebooks (ELN) with clarity and completeness.
Present scientific findings to project teams, management, and cross-functional stakeholders with confidence and scientific rigor.
Author technical reports, SOPs and development summaries and contribute to regulatory documents, scientific publications, and patent applications as needed.
Stay current with emerging trends and innovations in formulation science, analytical chemistry, and HPLC/UPLC technology; proactively apply learnings to internal programs.
Qualifications
Education
Bachelor’s degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or a related discipline with typically 4-5 years (Scientist I) or 7+ years (Scientist II) of relevant industry experience
Master’s degree in a related discipline with typically 2 years (Scientist I) or 5+ years (Scientist II) of relevant industry experience
Required Experience & Skills
Demonstrated hands-on experience in biologics drug product development, including formulation development, characterization, and stability assessment.
Strong practical understanding of protein degradation pathways and analytical characterization approaches used to assess biologic product quality.
Broad and deep hands-on expertise with HPLC/UPLC across multiple modalities (e.g. RP, SEC, IEC, HIC, etc.) with a proven track record as an SME, including method development and troubleshooting capabilities
Hands-on experience with analytical techniques used for protein characterization and stability testing (e.g., SEC, RP-HPLC, CE-SDS, icIEF, HIAC, MFI, DLS, SoloVPE or equivalent).
Experience with in-use stability and/or clinical compatibility studies for biologic drug products preferred.
Proficiency in scientific data analysis and statistical tools, especially chromatography data systems (e.g. Empower).
Strong oral and written communication skills, with experience authoring reports, standard operating procedures (SOPs), and regulatory documents.
Ability to independently manage multiple projects with competing priorities.
Preferred Experience
Experience with DoE (Design of Experiments) for formulation and process optimization.
Prior experience supporting IND, NDA, or BLA filings.
Experience contributing to scientific publications or patent applications.
Experience in automation and data digitalization.
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.
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
Job details
How this role compares
Computed from every other active Manufacturing & CMC role in our database, not just this employer's listings.
We currently track 3753 comparable Manufacturing & CMC roles across 173 biopharma companies.
Salary context
920 of 3753 peers report a salary range (USD, annualized)
Peers share this role's job function. This posting doesn't list a seniority level, so peers aren't narrowed by seniority either -- the range below may span more levels than usual.
Where these roles are based
Top locations among the 3753 comparable roles
+ 58 more countries
Seniority mix
1670 of 3753 peers have a known seniority level
Therapeutic area mix
24 of 3753 peers have a known therapeutic area; the rest are genuinely unlabeled, not hidden
Similar opportunities
The closest matches from our peer group, ranked by how similar they are, not how well you'd qualify for them -- treat this as market context, not a guaranteed shortlist; a weak match is labeled as one below.
Notify me about similar jobs
Get an email when we spot other openings like this one – same job function, comparable seniority, roles you'd actually want to see.
Or follow a whole field: get every new Manufacturing & CMC job in the United States, and choose locations and companies.
How we calculate "similar"
No black box, no LLM guesswork: a deterministic score built from four normalized attributes. Here's this role's own peer group at different match levels, so you can see the mechanism, not just the result.
Every comparison starts from the same 100-point budget: 25 for working in the same function, 40 for the same therapeutic area, 20 for the same or adjacent seniority, 15 for the same country. A dimension we can't confirm on both sides contributes nothing, never a guess, never a free pass.
0 points, never a partial guess. A role we know almost nothing about beyond its function bottoms out at 25%; it never inflates to 100% just because there's little to compare against. Seniority uses a defined ladder (Associate → Manager → Associate Director → Senior → Principal → Director → Senior Director → Executive/VP) so "Director" and "Senior Director" count as adjacent, but "Director" and "Executive/VP" do not.