Scientist II, Drug Substance Purification Development

Colorado State University, Health Network; Irvine (CA); On-site; USD 80,000 - 110,000; Full time

Job summary

A leading company in innovative medicines is seeking a Scientist II specializing in drug substance process development. This role will involve downstream/purification process development for biologics, with hands-on laboratory work and collaboration across teams. Candidates should have a strong background in protein chemistry and purification principles with essential hands-on experience in chromatography techniques. The position is based in Irvine, CA, offering a competitive salary and comprehensive benefits package.

Benefits

Paid time off

Medical/dental/vision insurance

401(k) plan

Short-term incentive programs

Qualifications

• Minimum 5 years experience with a Master's degree or 7 years with a Bachelor's degree.
• Hands-on experience with biologics purification processes.
• Excellent oral and written communication skills.

Responsibilities

• Perform laboratory work to develop biologics product candidates.
• Execute experiments for drug substance purification.
• Maintain laboratory equipment and organize inventory.

Skills

Protein chemistry

Chromatography

Purification principles

Data analysis

Experimental documentation

Education

BS or MS in Pharmaceutical Sciences, Microbiology, Biochemistry, or closely related field

Tools

AKTA chromatography system

TFF system

HPLC

Job description

ICompany Description

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 X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok.

Job Description

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

The desired candidate will have a good understanding of purification concepts and methodology and hands-on work experience with biologics purification process development, including process chromatography, ultrafiltration/diafiltration. The ability to demonstrate a significant level of hands-on experience in several of these areas is expected. Additional responsibilities include data analysis, troubleshooting process and equipment, lab inventory and organization, maintaining detailed records of batches and experiments. 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:

• Hands on laboratory bench work to develop and prepare biologics product candidates for various groups with tight timelines.
• Perform and support design and execution of experiments for drug substance purification process.
• Independently operate and have sound knowledge of TFF system and AKTA chromatography skid systems. Position requires proficient knowledge and hands on experience of clarification equipment as well.
• Routine down-stream purification operations relating to AKTA chromatography system prep: system set-up, assembly/disassembly, system clean-up, in process sampling, buffer preparation, and ability to troubleshoot operational and equipment issues
• Knowledge of HPLC instrument operations and method development is also preferred but not required.
• Must be willing to work with 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. Ability to perform all operations and manipulation under a biosafety laminar flow hood.
• The scientist must complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain all training to current status. Support safety program and ensure safety in all routine and new operations.
• Follow study protocols or batch records and execute experiments independently (or minimal supervision) at small and large scales.
• Author and edit development batch records and associated standard operating procedures.
• Communicate and work closely with members from different teams within process development and analytical development groups to foster a collaborative environment for advancement of projects.
• Assist the team in maintaining laboratory equipment, supply inventory, and organization.

Qualifications

• BS or MS in Pharmaceutical Sciences, Microbiology, Biochemistry, Biochemical/chemical engineering, or closely related field.
• Scientist II minimally requires a Master's degree with 5 years, or Bachelor's degree with 7 years of relevant industry experience.
• Must have in depth knowledge of protein chemistry, chromatography, and purification principles

• Hands-on experience in the operation of TFF and purification AKTA chromatography system is 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 is required.
• Must have a team-centric mindset in order to integrate seamlessly in a team setting when working/collaborating with other members within the group and with other groups.
• Excellent oral and written communication skills is required as is experience with documentation of experimental plans, analyzing data and generating high quality technical reports.

Additional Information

Applicable only to applicants applying to a position in any location with pay disclosure requirements under state or local law:

• This is an on-site opportunity in Irvine, CA that will work directly with Toxins in a lab-based environment.
• 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.

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https://www.abbvie.com/join-us/reasonable-accommodations.htmlI