Senior Scientist I/II, Drug Substance Development

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 – immunology, oncology, neuroscience, and eye care – and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at www.abbvie.com. Follow @abbvie on Twitter, Facebook, Instagram, YouTube and LinkedIn.

AbbVie is recruiting for a Sr. Scientist I/II, Drug Substance Development position in the Department of Neurotoxin & Biologics Process Sciences (NBPS), at its Irvine, CA site.

Position Description:

The Sr. Scientist I/II, Drug Substance Development will be an instrumental team member of the NBPS group. The primary roles of this position are to lead drug substance Upstream process development and optimization studies for natural and recombinant proteins (including neurotoxins) from bacterial cultures during discovery and process development.

The desired candidate will have a solid understanding and hands-on work experience with biologics Upstream process development, including microbial cell line development, production fermentation, harvest/clarification, and process characterization. The successful candidate will perform laboratory work, develop productive collaborations and communications with other groups across scientific disciplines and be motivated to innovate and succeed in a fast-paced, collaborative environment. 

Key Responsibilities:

• Lead research and development studies, author research protocols/reports and present findings in the multidisciplinary team environment.
• Perform and support process mapping, design and execution of experiments for upstream drug substance manufacturing process.
• Demonstrate significant level of hands-on experience and in-depth knowledge in upstream processes, design and execution of the studies by applying quality by design (QbD), scientific and/or engineering principles and practices, scale-up and scale-down model qualifications and daily operations of upstream activities.
• The role requires evaluating new technologies relevant to cell line development, fermentation, and harvest operations to enhance process understanding.
• Work closely with members of process development and analytical development groups in creating a collaborative environment for advancement of robust manufacturing processes.
• Represent the department and participate in cross-functional CMC project teams.
• Display leadership skills that result in good performance and career development of junior staff and possess excellent communication (oral and written) and interpersonal skills.

Qualifications

• BS, MS, or PhD in Pharmaceutical Sciences, Microbiology, Biochemistry, Biochemical/chemical engineering, or closely related field. 
• Senior Scientist I minimally requires a PhD (no additional experience required), Master’s degree with 8 years, or Bachelor’s degree with 10 years of relevant industry experience.
• Senior Scientist II minimally requires PhD and 4 years, Master’s degree with 10 years, or Bachelor’s degree with 12 years of relevant industry or post-experience.
• Experience in microbial cell line development, fermentation and cell harvest operations, as well as statistical experiment design/data analysis skills are highly desired.
• Familiarity with pharmaceutical regulations and guidelines (Example: FDA and EMA).
• Experience in developing novel manufacturing technologies is desirable.
• Experience with Process Analytical Technology (PAT) and data analytics is desirable.
• Experience with microbial strain construction and molecular biology techniques is desirable, but not required.
• Proven ability to work independently, effectively plan and organize work activities, and prioritize task completion to meet project deadlines in a fast-paced environment required.
• Excellent oral and written communication skills required as is experience with documentation of experimental plans, analyzing data and generating high quality technical reports.
• Motivated to work in a team environment and an awareness to drive continuous improvements required. 

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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. ​

• 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 committed to operating with integrity, driving innovation, transforming lives, serving our community and embracing diversity and inclusion.  It is AbbVie’s policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a protected veteran, or any other legally protected group status.