Senior Scientist I, Drug Product Development
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What you'll do
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Support scale-up and technology transfer activities to internal and external manufacturing sites.
- Keep abreast of the latest advances in biologics formulation and process technologies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
- May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
- Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
What they're looking for
- Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD 0+ years of industry experience.
- Proven ability to solve critical scientific problems.
- Hands-on experience with biologics formulation development.
- Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
- Solid understanding of biologics degradation mechanisms and stabilization strategies.
- Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
Nice to have
- Understanding of relevant cGMP and regulatory guidance.
- Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
- Experience in managing third party manufacturers.
- Experience with quality risk management and drug product control strategies.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
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
Biologics Drug Product Development (Bio DPD), a part of Development Sciences within AbbVie’s R&D, is a global organization that is responsible for drug product formulation and process development, and definition of the product presentation for biologics and genetic medicine (proteins, conjugates, peptides etc.).
AbbVie is seeking a highly motivated candidate for the position of Senior Scientist I, Biologics Drug Product Development, located in North Chicago, IL. We are seeking an accomplished scientist with a proven track record in biologics formulation and process development, and characterization. This position will be an integral part of the product development and CMC teams and will have strong collaborations with several stakeholders, including discovery research, analytical research and development, bioprocess development, combination products development, science and technology, pilot plants and third-party manufacturers.
Responsibilities
- Lead the design and execution of biologics drug product formulation and process development, characterization and robustness studies.
- Support scale-up and technology transfer activities to internal and external manufacturing sites.
- Keep abreast of the latest advances in biologics formulation and process technologies.
- Initiate and/or support scientific initiatives to drive innovation, continuously enhance capabilities and improve business processes.
- May represent the Bio DPD function in the cross-functional Product Presentation and Device Strategy Team (PPDST) and the CMC team.
- Effectively and timely communicates study plans, risks and mitigation plans to stakeholder and line management.
Qualifications
- Bachelor’s Degree or equivalent education and typically 10 years of experience, Master’s Degree or equivalent education and typically 8 years of experience, PhD 0+ years of industry experience.
- Proven ability to solve critical scientific problems.
- Hands-on experience with biologics formulation development.
- Hands-on experience with analytical and biophysical characterization of proteins and solid-state characterization methods.
- Solid understanding of biologics degradation mechanisms and stabilization strategies.
- Hands-on experience with Design of Experiments (DoE), multivariate statistical analyses and data visualization tools.
Highly Preferred Qualifications:
- Understanding of relevant cGMP and regulatory guidance.
- Experience with sterile manufacturing unit operations (freeze-thaw, mixing, filtration, filling, and lyophilization) development, characterization, scale-up and technology transfer.
- Experience in managing third party manufacturers.
- Experience with quality risk management and drug product control strategies.
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
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