Manufacturing Scientist I/II (Pilot Plant), Drug Substance Process 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 Manufacturing Scientist I/II, Drug Substance Process Development position in the Department of Neurotoxin & Biologics Process Sciences (NBPS), at its Irvine, CA site.

Position Description:

The Manufacturing Scientist I/II, Drug Substance Process Development, will be an instrumental team member of the NBPS pilot plant group. The primary responsibility of this position is to support and execute drug substance fermentation and harvest operations for natural and recombinant proteins (including neurotoxins) from bacterial cultures. Following appropriate guidance, the candidate assembles, tests and inspects for issues, operates during the production process, and ensures all safety procedures are followed.

The desired candidate will have a good understanding of fermentation concepts, equipment and methodology. The candidate should have hands-on experience with fermenter operation and microfiltration/ultrafiltration equipment. Skills with protein precipitation/extraction is desired but not required. The successful candidate will perform laboratory work in a team setting, develop productive collaborations with other groups and be motivated to innovate and succeed in a collaborative environment.

Key Responsibilities:

• Operations: Supports and executes BSL3 R&D pilot plant activities pertaining to fermentation process operation: media, buffer and reagents preparation, fermenter assembly/disassembly, SIP/CIP, microfiltration/ultrafiltration, and process sampling. Ability to perform aseptic cell propagation and manipulation under a biosafety laminar flow hood. Ensures the batch record preparation and execution with minimal errors and close out of batch records. Starts and completes manufacturing activities on time, according to the established schedule. In addition to primary responsibilities, desire to operate small-scale fermenters and associated equipment and other hands-on bench work as assigned by scientists.
• Must have the ability to multitask. Must work in a team setting with other members of the group and prioritize and allocate time and effort appropriately. Must be able to lift up to 50 lbs.
• Technical Support: Provides meaningful assistance with troubleshooting and helps identify solutions to issues that may arise during executions; Supports product development and technology improvement activities including developing and piloting new and innovative operational systems that could be transferred to manufacturing area.
• Compliance:  Follows established policies, procedures, and practices; Conducts business activities needing minimal deviations or exceptions; Follows established safety requirements, reports incidents/near misses and recommends improvements.
• Inventory: Maintain select agent and toxin sample inventory.
• Project coordination: Assists in scheduling work tasks, works with the BSL3 pilot plant team and other supporting areas to assure project commitments are meet, for example, providing draft batch records for review, assuring material availability, preparing cleaning documentation and completing inventory transactions.
• Communication: Reports significant issues to management with appropriate sense of urgency; Attends group and project meetings, being prepared to communicate concerns, and participate in discussions.
• Must be willing to work in BSL3 laboratories and handle potent neurotoxins and in-process samples that contain neurotoxin and neurotoxin expressing organisms. Learn and develop a safety mindset and adhere to safety procedures regarding neurotoxin handling.
• Assist the team in maintaining laboratory equipment, supply inventory, and organization.

• BS or MS in Chemistry, Biochemistry, Microbiology, Biochemical/chemical engineering, or closely-related operation area or equivalent.
• Experience in manufacturing operation, R&D, or related area.
• Scientist I requires BS and 5 years or MS and 3 years of related experience. Scientist II requires BS and 7 years or MS and 5 years of related experience.
• Hands-on experience in fermentation-related activities and UF/DF operation.
• Must have a team-centric mindset to integrate seamlessly in a team setting when working/collaborating with other members within the group and with other groups.
• Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
• Continuous improvement mindset.

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 a 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. ​

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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.