HPLC Specialist, Scientist II, Biologics Drug Product Development

Posted 2 Days Ago
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South San Francisco, CA, USA
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
Lead HPLC/UPLC characterization and troubleshooting for biologics, develop and execute drug product formulation and process development studies, generate regulatory-ready data packages, train staff and maintain SOPs, collaborate cross-functionally, document results in ELNs, and support automation and data integrity initiatives (Empower superuser).
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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, antibody-drug conjugates (ADCs), neurotoxins, and novel biologic formats) from preclinical development through clinical proof of concept.

We have an exciting opportunity for an HPLC Specialist (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. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross functional interactions between scientists.

 

KEY RESPONSIBILITIES INCLUDE:

HPLC/UPLC Subject Matter Expertise

  • Serve as the department SME for HPLC/UPLC characterization of biologics, demonstrating advanced knowledge of reversed-phase, ion-exchange, size-exclusion, hydrophobic interaction, and other HPLC/UPLC modalities relevant to characterization of biologics.
  • Lead advanced troubleshooting of HPLC/UPLC instrumentation (e.g., pumps, autosamplers, detectors, columns) and chromatographic methods.
  • Be accountable and responsible for resolving instrument issues to minimize downtime and work in alignment with team to oversee preventive maintenance schedules and coordinate with instrument vendors and metrology teams to ensure instrument qualification and compliance.
  • Support company initiatives to increase automation capabilities related to HPLC data collection, storage and overall data integrity; act as an Empower software superuser
  • Develop and deliver HPLC training curricula, maintain SOPs and training materials, and serve as a technical resource and scientific consultant on HPLC-related matters.

Formulation & Biologics Drug Product Development

  • Independently lead and execute drug product process development studies to support clinical studies, including formulation screening, in-use studies, and manufacturing process support.
  • Generate robust scientific data packages to support IND/NDA/BLA regulatory submissions, CTD module documentation, and technical reports.
  • Collaborate with cross-functional partners including Analytical Development, Drug substance, Regulatory Affairs, and Quality to advance programs through the development pipeline.
  • Drive continuous improvement of formulation strategies and drug product processes, applying scientific rigor and innovation.

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.
  • Contribute to technical reports, regulatory documents, SOPs, 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

· Deep, hands-on expertise with HPLC across multiple modalities (RP-HPLC, SEC, IEC, HIC, etc.) with a proven track record as an SME, including method development and troubleshooting capabilities

Demonstrated expertise in formulation development and drug product development for small molecules and/or biologics, including solid oral dosage forms, parenteral, or other delivery systems

· Proven ability to train and develop others on HPLC instrumentation and analytical methods

· Proficiency in scientific data analysis and statistical tools, especially chromatography data systems (e.g. Empower)

· Excellent technical writing skills with experience authoring reports, SOPs, and regulatory documents

· Ability to independently manage multiple projects with competing priorities

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

Skills Required

  • Bachelor's degree in Pharmaceutical Sciences, Chemistry, Biochemistry, Chemical Engineering, or related discipline with relevant industry experience
  • Master's degree in a related discipline (alternative to Bachelor's with reduced experience requirement)
  • Deep, hands-on expertise with HPLC/UPLC across modalities (RP-HPLC, SEC, IEC, HIC) including method development and troubleshooting
  • Demonstrated expertise in formulation development and drug product development for small molecules and/or biologics
  • Proven ability to train and develop others on HPLC instrumentation and analytical methods
  • Proficiency in scientific data analysis and statistical tools, especially chromatography data systems (e.g., Empower)
  • Excellent technical writing skills with experience authoring reports, SOPs, and regulatory documents
  • Ability to independently manage multiple projects with competing priorities
  • Experience troubleshooting HPLC instrumentation, overseeing preventive maintenance, and coordinating vendor/metrology support for instrument qualification and compliance

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.

  • 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.
  • 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.
  • 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.

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The Company
HQ: North Chicago, IL
50,000 Employees
Year Founded: 2013

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.

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