Scientist l, Biologics Analytical R&D

AbbVie Inc.; Irvine (CA); On-site; USD 85,000 - 125,000; Full time

Job summary

AbbVie Biologics Analytical Research & Development in Irvine seeks an experienced candidate for analytical roles focused on early-stage CMC activities for biologics. You will work in GMP environments performing separation and compendial testing (HPLC, CE, icIEF) and contribute to cross-functional team efforts.

You will collaborate with Biologics Development and ensure data integrity, regulatory compliance, and timely reporting of observations to enable high-quality product development.

Qualifications

• Bachelor's degree with typically 3+ years of experience or Master with up to 2 years in a GxP-regulated environment.
• Scientist I: Bachelor's with 5+ years or Master with 2+ years in a GxP-regulated environment.
• Understanding in CMC development strategy of biologics drugs is expected.
• Experience with separation methods for biologics (HPLC RP/SEC/AEX/CEX), CE, icIEF, and other compendial techniques in a cGMP environment.
• Strong communication and presentation skills with the ability to convey technical data clearly.

Responsibilities

• Adhere to GMP, guidelines and regulations to ensure products are analyzed per quality standards.
• Review methods, protocols and SOPs for GMP adherence.
• Perform separation and compendial testing of materials and products using HPLC, CE, and related techniques.
• Collaborate with cross-functional Biologics Development teams and share scientific expertise.
• Maintain reagents, notebooks, and summarize results in written reports.

Skills

GMP principles

GxP experience

HPLC familiarity

Capillary electrophoresis

Data integrity understanding

Strong communication

Education

Bachelor's Degree (3+ years in GxP)

Master's Degree (up to 2 years in GxP)

Job description

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, Xand YouTube.

Job Description

AbbVie Biologics Analytical Research & Development (Biologics Analytical R&D) at Irvine is an analytical sciences organization responsible for early-stage CMC analytical activities related to the development of AbbVie's biologics products. Careers in AbbVie Biologics Analytical R&D provide opportunities to work collaboratively with cross-functional teams to drive scientific understanding and innovative product development strategies. The biologics characterization group develops analytical techniques for in-depth characterization of biologics using separation and compendial techniques. We are looking for candidates with strong scientific experience to join the AbbVie Analytical R&D team and can offer exciting career opportunities for these candidates.

Responsibilities

The position requires the individual to work with and in areas requiring select agents access (i.e. Biosafety level 2 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with AbbVie internal and applicable regulatory requirements. AbbVie internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.

• Strong understanding, knowledge and ability to adhere to and apply Good Manufacturing Practices (GMP), guidelines and regulations ensuring products are consistently analyzed according to quality standards required in a GMP environment.
• Possess a strong understanding of compendial methodology (USP/EP/JP).
• Perform separation and compendial testing of raw materials, drug substances, and drug products using techniques such as HPLC, Capillary Electrophoresis, Particulate Matter, Osmolality, Karl Fischer, pH.
• Review methods, protocols and SOPs for adherence to GMP principals.
• Participate in cross-functional teams within Biologics Development and provide support and feedback to external departments. Openly share scientific expertise and collaboratively help the team to formulate rational solutions to problems.
• Maintain reagent supplies, notebooks, summarize results in written reports and communicate observations to ensure that the end user receives quality methods in a timely manner. Comply with Quality Principals related to data generation and reporting.
• Ensure laboratory activities comply with applicable AbbVie safety, quality, data integrity, and regulatory requirements.

Qualifications

• Associate Scientist II: Bachelor Degree with typically 3+ years of experience or Master degree with up to 2 years of experienceworking in a GxP-regulated environment.
• Scientist I: Bachelor’s Degree or equivalent education with typically 5+ years of experience, or Master’s Degree or equivalent education with typically 2+ years of experience working in a GxP-regulated environment.
• Understanding in CMC development strategy of biologics drugs is expected.
• Experience and working knowledge in executing separation methods for biologics, including HPLC (RP, SEC, AEX, CEX), gel and capillary electrophoresis (CE, icIEF), as well as compendial techniques, in a cGMP environment.
• General understanding in CMC development strategy of biologics drugs is expected.
• Strong communication and presentation skills, with the ability to clearly communicate technical data, conclusions, and recommendations to diverse technical teams.
• Strong organizational skills with the ability to manage multiple priorities.
• Working knowledge of data integrity, laboratory safety, and compliance expectations associated with GxP-regulated analytical testing.

Additional Information

• The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at thetimeofthis posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographiclocation,andwemay ultimately pay more or less than the posted range. This range may bemodified in thefuture.

• We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees.

• This job is eligible toparticipate in our short-term incentiveprograms.

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 employer 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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