Senior Scientist II, Downstream Purification, Toxins

Posted 20 Hours Ago
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Irvine, CA, USA
In-Office
Senior level
Healthtech • Pharmaceutical
The Role
The Senior Scientist II will support bioprocess development and technology transfer, focusing on toxin manufacturing processes. Responsibilities include experiment design, data analysis, and product investigations, ensuring compliance with regulatory standards.
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 II, Downstream Purification 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 protein recovery and purification process that utilizes clarification, chromatography, and membrane filtration technologies. Provide deeper understanding of process performance using appropriate experimental and modeling tools.
  • Design, execute and analyze experiments using a robust scale-down model for process characterization and continued process improvement of commercial biologics products.
  • Leverage data science and advanced mechanistic modeling to build digital platforms for data visualization, analysis and prediction.
  • Support/ lead new product introduction into the manufacturing area, ensuring successful tech transfer, scale up and validation for the product.
  • Support product investigations and non-conformances. Identify root causes and make scientific recommendations as to the acceptability and quality of affected product lots.
  • 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 12+ (BS), 10+ (MS) or 4+ (PhD) years of postdoc or industry related experience.
  • Experience in areas of bioprocess development, process characterization, modeling, validation, regulatory submissions, and manufacturing support.
  • Demonstrate independence leadership and enterprise mindset
  • 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 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 long-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

  • BS, MS, or PhD in Chemical Engineering, Biochemistry, or closely related field
  • Typically 12+ years (BS), 10+ years (MS), or 4+ years (PhD) of related experience
  • Experience in bioprocess development and regulatory submissions
  • Knowledge of GMP
  • Excellent communication and problem-solving skills
  • Ability to work in a cross-functional team 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 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: 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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