Senior Scientist I, Upstream Process

Posted 2 Days Ago
Be an Early Applicant
Irvine, CA, USA
Hybrid
97K-184K Annually
Senior level
Healthtech • Pharmaceutical
The Role
Develops and optimizes upstream biologics manufacturing processes, including cell banking, fermentation, harvesting, scale-up, validation, troubleshooting, and continuous improvement. Designs and analyzes scale-down experiments, supports microbiology and manufacturing readiness, applies systems biology and data science, and contributes to CMC regulatory submissions, inspections, and cross-functional development programs.
Summary Generated by Built In
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 Product Development, Science and Technology (PDS&T), Toxins group supports manufacturing, process characterization, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxin products in AbbVie. We have an exciting opportunity for a Senior Scientist I, Upstream Toxin Process position based in Irvine, CA. The scientist will apply scientific, engineering principles, modeling and statistical process design/analysis to develop robust toxin manufacturing process hands-on. The candidate must have in-depth knowledge and hands-on experience including but not limited to bioprocess development, scale down model qualification, protein characterization, etc. Excellent communication skills and the ability to work within a multi-disciplinary and cross-functional teamwork environment are essential. 

Responsibilities:

  • Support late stage and commercial biologics manufacturing, technology transfer, process validation, investigations, troubleshooting, scale-up, and continuous improvement.
  • Develop and optimize upstream process conditions, including cell bank generation, fermentation culture and harvest strategies, to improve productivity, product quality, and process robustness.
  • Design, execute and analyze experiments using a robust scale-down model for upstream process characterization and continuous improvement of commercial biologics products.
  • Provide microbiology support for new product introduction, including contamination risk assessment, environmental monitoring strategy support, and coordination of microbiological activities as needed for manufacturing readiness.
  • Evaluate system biology tool to enhance understanding on cellular metabolism.
  • Leverage data science and advanced modeling to build digital platforms for data visualization and analysis.
  • Author and review relevant CMC sections of submissions and support agency inspections, inquiries and audits.
  • Represent the PDS&T Toxins group in CMC program teams. Interact effectively with diverse groups within function and maintain strong working relationships with internal, global, and external collaborators.

Qualifications

  • BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry or closely related field with typically 10+ (BS), 8+ (MS) or 0+ (PhD) years of postdoc or industry related experience.
  • Experience in areas of bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
  • Hands-on experience with upstream process development, microbiology, scale-down model development/qualification, and upstream process optimization.
  • Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
  • Excellent communication, writing and presentation skills are required.
  • Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency and self-motivated desire to achieve.
  • Demonstrated knowledge of GMP and experience providing technical support in a GMP manufacturing environment
  • Demonstrated ability to collaborate effectively in a dynamic, cross-functional matrix environment

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 roleat  the time of this posting based on the job grade for this position. Individual compensation paid within this range will depend on manyfactors  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 isearned,  vested,  and determinable. The amount and availability of  any bonus, commission, incentive, benefits, or any other form of compensation and benefits that areallocable 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 absolutediscretion,  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

  • BS, MS, or PhD in Chemical Engineering, Biochemistry, Chemistry, or a closely related field
  • Typically 10+ years of relevant post-degree or industry experience with a BS, 8+ years with an MS, or 0+ years of postdoctoral or industry experience with a PhD
  • Experience in bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support
  • Hands-on experience with upstream process development, microbiology, scale-down model development and qualification, and upstream process optimization
  • Demonstrated knowledge of GMP and experience supporting technical activities in a GMP manufacturing environment
  • Excellent problem-solving, communication, writing, and presentation skills
  • Ability to collaborate effectively in a dynamic, cross-functional matrix environment

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 Retirement programs are portrayed as a standout, with a dollar‑for‑dollar 401(k) match up to 6% and an additional annual company contribution based on age and service. Feedback suggests this materially boosts perceived total compensation for many U.S. employees.
  • Parental & Family Support Paid parental and caregiver leave are emphasized, including up to 12 weeks of fully paid parental leave for all parents and 4 weeks of paid caregiver leave in the U.S. Feedback suggests these policies are a meaningful differentiator for employees balancing family needs.
  • Leave & Time Off Breadth Time off is described as extensive, with tiered vacation that scales with tenure, 17 company holidays, and two paid volunteer days in the U.S. Feedback suggests the breadth of leave contributes notably to overall benefits satisfaction.

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The Company
HQ: North Chicago, IL
56,000 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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