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Scientist II, Process Analytics

Company 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 TwitterFacebookInstagramYouTube and LinkedIn

Job Description

The Biologics CMC Development team at AbbVie in the Bay Area has a long and rich history of biologics development. Now located in a new state of the art facility in South San Francisco, the team leverages its comprehensive end-to-end CMC capabilities to work collaboratively through all phases of CMC development with a primary focus on advancing complex biologic therapies, such as bi-specifics and novel modalities, to human clinical studies and eventual licensure.

AbbVie’s Biologics CMC Analytical Research and Development Group in South San Francisco has an exciting opportunity for a Senior Scientist I to join a new team responsible for process analytics. The Process Analytics team’s mission is to provide enhanced understanding of cell line, upstream, and downstream processes, and to streamline process development decisions and timelines through application of data-rich, high-throughput, rapid-turnaround analytics, and automation. In this role, you will report to the Process Analytics team lead and be responsible for analytical testing and evaluation of process intermediates to enable cell line, cell culture, and purification development. Additionally, you will be responsible for conceiving, developing, and implementing innovative, fit-for-purpose in-process methods that advance analytical capabilities to enable cell line and process development.

Responsibilities include:

· Conceive and develop innovative, data-rich, high-throughput, and automated in-process analytical methods and workflows to enable and enhance process understanding and process development efficiency.

· Perform analytical testing of process intermediates using LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, and automation.

· Collaborate closely with Cell Line Development and Process Development scientists to plan and execute analytical testing for process development experiments.

· Interpret and communicate in-process analytical results to cross-functional collaborators and stakeholders in a manner that informs cell line selection and process development decisions.

· Collaborate and communicate effectively with Analytical Molecule Leads to provide data and results from in-process testing for consideration in the context of the overall Analytical Development/QC control strategy.

· Engage with analytical subject matter experts (SME) to investigate in-process findings that warrant further interrogation with advanced extended characterization methodologies.

· Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.

· Serve as an SME for in-process analytics on cross-functional teams.

· Document laboratory work according to good documentation practices.

· This position is an onsite, lab-based role. To be successful, candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Qualifications

  • BS or equivalent education with typically 7 or more years of experience or MS or equivalent education with typically 5 or more years of experience.
  • Expertise with at least one of the following technologies: MAM, LCMS peptide mapping, mass spectrometry, U/HPLC, capillary electrophoresis, ELISA, QPCR, and optical plate reader assays.
  • Demonstrated “super-user” level experience developing complex methods, as listed above, on integrated liquid handling automation systems in collaboration with colleagues such as SME’s and automation engineers.
  • Focus on sustained analytical throughput and data quality in a development or production environment including control strategies such as continuous improvement, control charting, and CAPA.
  • Has independently managed on-going deliverables and timelines for analytical testing projects.
  • Has championed efficient lab and end-user centric ELN/LIMS solutions for data capture, metadata capture, and reporting.
  • General understanding of CMC Analytical Development of protein therapeutics is desired.
  • Experience in application of analytical methods to characterize process development in multi-step biological workflows is a bonus.
  • Pluses includes background in DOE, statistical methods, and data visualization.
  • Proven ability to develop innovative solutions to difficult technical challenges to achieve project goals.
  • Must have effective communication skills, including verbal, written, and scientific data presentation.
  • Must be forward-thinking and able to lead and contribute to scientific/technical discussions.
  • Ability to independently learn, understand and execute novel/advanced scientific techniques.
  • Ability to author technical reports and presentations.
  • Must have ability to work collaboratively with a high degree of productivity in a dynamic, fast-paced, cross-functional environment.

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, 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.

US & Puerto Rico only - to learn more, visit https://www.abbvie.com/join-us/equal-employment-opportunity-employer.html 

US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more:

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

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What You Should Know About Scientist II, Process Analytics, AbbVie

Are you ready to take your career to the next level? AbbVie is on the lookout for a passionate and skilled Scientist II, Process Analytics to join our dynamic Biologics CMC Development team in sunny South San Francisco, CA. At AbbVie, we’re committed to making a real impact on people’s lives through innovative medicines and solutions. In this role, you will have the chance to work with cutting-edge technologies, helping to advance complex biologic therapies from the lab to human clinical studies. You'll be at the forefront of process analytics, providing insights into cell lines and production processes, all while collaborating closely with talented scientists across various disciplines. Your days will be filled with exciting challenges, from developing high-throughput analytical methods to performing sophisticated testing using LCMS, mass spectrometry, and more. We're looking for someone who thrives in a collaborative environment, enjoys problem-solving, and has a strong background in analytical development. With AbbVie, you’ll not only advance your career but also contribute to groundbreaking work that changes lives. If you're ready to make a difference in the field of biologics and help shape the future of healthcare, we want to hear from you!

Frequently Asked Questions (FAQs) for Scientist II, Process Analytics Role at AbbVie
What responsibilities does the Scientist II, Process Analytics at AbbVie have?

The Scientist II, Process Analytics at AbbVie is responsible for developing innovative in-process analytical methods, performing analytical testing of process intermediates, and collaborating with cross-functional teams. This role focuses on enhancing process understanding and efficiency in biologic development, ensuring that analytical results inform critical decisions.

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What qualifications are required for the Scientist II position at AbbVie?

To qualify for the Scientist II, Process Analytics role at AbbVie, candidates should possess a BS degree with at least 7 years or an MS degree with 5 years of relevant experience. Expertise in technologies like LCMS, mass spectrometry, and ELISA is essential, along with strong communication skills and experience in collaborative lab settings.

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How does the Scientist II role at AbbVie contribute to biologics development?

The Scientist II, Process Analytics plays a crucial role in advancing biologics development by devising high-throughput analytical methods that streamline and enhance the process. By providing clear analytical insights, this position helps in making informed decisions for cell line selection and production processes.

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What technologies does the Scientist II at AbbVie work with?

In the Scientist II, Process Analytics role at AbbVie, you'll work with a variety of advanced technologies including LCMS for peptide mapping, mass spectrometry, U/HPLC, and ELISA. Experience with these tools is key to successfully executing the analytical testing required in this highly collaborative environment.

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What kind of work environment can a Scientist II expect at AbbVie?

The work environment for a Scientist II, Process Analytics at AbbVie is dynamic and collaborative, focused on innovative solutions and effective communication. Expect daily interactions with scientists from different disciplines in an onsite lab, contributing to teamwork that propels the advancement of biologics therapies.

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Common Interview Questions for Scientist II, Process Analytics
Can you explain your experience with LCMS and how it applies to the Scientist II role at AbbVie?

When answering this question, highlight your familiarity with LCMS techniques, detailing specific projects where you've applied these skills. Discuss how your experience aligns with AbbVie's need for high-throughput methods in process analytics and emphasize your ability to contribute to innovative solutions.

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Describe a challenging analytical problem you encountered and how you solved it.

Use the STAR method (Situation, Task, Action, Result) to structure your response. Begin by describing the challenge and its impact on your project. Then, explain the steps you took to analyze the problem, the innovative solution you implemented, and the positive outcome of your actions.

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How do you prioritize and manage multiple analytical projects?

Discuss techniques you use for project management, such as setting clear deadlines, communicating with stakeholders, and using tools for tracking progress. Provide a specific example where you successfully managed competing priorities in a previous role, showcasing your ability to stay organized and focused.

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What strategies do you employ to ensure data quality during analytical testing?

Explain the importance of data integrity and the strategies you use to maintain it, such as regular calibration of instruments, adherence to Good Documentation Practices (GDP), and proper training. Provide a relevant example that illustrates your commitment to high quality and reproducibility in your work.

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How do you approach collaboration with cross-functional teams?

Emphasize the importance of open communication and respect for different expertise when collaborating. Provide an example of a successful cross-functional project, detailing how you engaged with other team members to achieve common goals and contributed positively to the team dynamic.

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What is your experience with automation in analytical testing?

Describe your experience with developing and implementing automated workflows in the lab, including any systems you've used. Highlight the benefits of automation you've observed, such as increased throughput or reduced human error, and express your enthusiasm for continuing to innovate in this area.

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Can you discuss a time you had to learn a novel scientific technique quickly?

Discuss a specific instance where you had to rapidly acquire knowledge on a new analytical technique. Explain your approach to learning, any resources you used, and how you successfully applied it in your work, emphasizing your adaptability and eagerness to expand your skillset.

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How do you ensure compliance with regulatory standards in your analytical work?

Emphasize your commitment to adhering to industry regulations and company standards. Discuss your experience with regulatory guidelines in previous roles and how you incorporated those into routine lab practices to ensure compliance during analytical testing.

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Tell us how you handle feedback on your analytical methods.

Talk about your mindset towards feedback as a learning opportunity. Provide an example of a time you received constructive criticism on your methodology, how you addressed it, and what changes you implemented as a result to improve your work.

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What do you think are the biggest challenges facing process analytics in biologics development today?

Demonstrate your industry knowledge by discussing current challenges such as evolving regulations, the need for rapid development timelines, or maintaining data integrity. Share your ideas on how you could potentially address these challenges and contribute to AbbVie’s mission.

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AbbVie’s mission is to discover and deliver innovative medicines 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: i...

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December 12, 2024

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