AbbVie

Principal Research Scientist II/ Associate Director- Eyecare

AbbVie • $150K — $180K *
Irvine, CA 92620In-Person
Pharmaceuticals & Biotech
8 - 10 years of experience
Today
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Job Overview by Ladders

Qualifications

  • Bachelor's in Science with 16 years, Master's with 14 years, or PhD with 8 years of relevant experience.
  • History of successful product innovations and improvements.
  • Strong collaborative skills for engaging with various teams and stakeholders.

Responsibilities

  • Lead formulation and process development for sterile liquid dosage forms and eyecare products.
  • Execute development strategies for clinical and commercial products.
  • Maintain expertise in global CMC submission and compliance standards.
  • Advance scientific excellence through publications and regulatory filings.
  • Manage relationships with CROs and CMOs for outsourced development projects.
  • Represent the department in cross-functional project teams to meet objectives.
  • Coach and develop team members, fostering a culture of collaboration and safety.

Benefits

  • Paid time off including vacation and holidays.
  • Medical, dental, and vision insurance.
  • 401(k) plan participation for eligible employees.
  • Eligibility for long-term incentive programs.
Full Job Description
Job Description

The Principal Research Scientist II / Associate Director provides scientific, technical, and people leadership for the formulation and process development of sterile liquid dosage forms, with an emphasis on eyecare products. The role directs development activities for new chemical entities and life-cycle management programs from early research through clinical supply, technology transfer, regulatory submission, and commercialization. The candidate leads a team of scientists responsible for formulation, process, and associated analytical-method development.

Responsibilities:
  • Provide scientific and technical leadership for the development of sterile liquid dosage forms and eyecare products, including formulation, associated analytical methods, and manufacturing processes. Apply Quality by Design principles and statistical experimental design and analysis to build product and process understanding and support robust development decisions.
  • Plan, direct, and execute formulation and process-development strategies for new products intended for clinical trials and commercialization. Lead research in sterile product development to advance innovative products and life-cycle management opportunities.
  • Develop and maintain current, in-depth knowledge of global CMC submission requirements and GLP/GMP expectations. Review internal and external technical documents and author technical memoranda, reports, patent applications, and scientific articles.
  • Advance scientific excellence in sterile liquid dosage-form formulation and process development through high-quality technical reports, peer-reviewed publications, professional society participation, regulatory filings, and patents.
  • Collaborate with CROs and CMOs specializing in sterile liquid dosage forms. Manage outsourced development activities, technical deliverables, timelines, and quality expectations in alignment with global regulatory requirements.
  • Represent the department on CMC and project teams, partnering with Pharmaceutical Sciences functions, manufacturing sites, Process Chemistry, Toxicology, Regulatory Affairs, Quality, Clinical Development, Marketing, and external CROs and CMOs to achieve project objectives and timelines.
  • Interpret and apply current global CMC regulatory requirements and guidance to development programs, technical documentation, regulatory submissions, and responses to health-authority questions in support of product registration.
  • Lead, coach, and develop direct reports by setting priorities, providing timely feedback, supporting career development, and fostering scientific rigor, accountability, collaboration, inclusion, and laboratory safety. Communicate complex scientific and business information clearly in written and oral formats to technical and nontechnical stakeholders


Qualifications
  • Bachelor's Degree in Science related field with 16 years of related work; Master's Degree Science or PharmD with 14 years of related work; PhD in Science or related field with 8 years of related work experience.
  • Proven ability to innovate with a history of new or improved product releases.
  • Interacts well with diverse groups within function and maintains strong working relationships with internal and external collaborators.

Preferred Qualifications:
  • Proven track record of developing and manufacturing sterile liquid dosage forms, demonstrated through approved products, successful regulatory submissions, technology transfers, patent applications, or other significant technical achievements. In-depth understanding of sterile liquid product development is required, including pharmaceutical formulation principles, manufacturing process development, technology transfer, and global CMC regulatory requirements.
  • Experience managing technical development and manufacturing activities with CROs and CMOs specializing in sterile liquid dosage forms.
  • Ability to establish and maintain effective relationships with management, co-workers and customers and work well in a team environment.
  • Experience leading manufacturing process scale-up and technology transfer for sterile liquid dosage forms from development through commercial readiness.
  • Experience applying Quality by Design principles and statistical experimental design and analysis, including the use of JMP or comparable statistical software, to formulation and process development.
  • Working knowledge of characterization techniques used to assess critical quality attributes of sterile liquid dosage forms, together with comprehensive knowledge of raw-material properties and their effects on product performance, stability, processability, and manufacturability.
  • Strong working knowledge of FDA, EMA, and ICH CMC guidance and GMP requirements, with demonstrated experience preparing or supporting global regulatory submissions.
  • Demonstrated supervisory experience, including setting priorities, allocating work, monitoring progress against project timelines, coaching and developing scientific staff, resolving technical and operational issues, ensuring complete and accurate laboratory records, and promoting compliance with laboratory safety and quality requirements.


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 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.

About AbbVie

AbbVie develops pharmaceuticals and medical devices. They provide products and services to therapeutic areas including immunology, oncology, neuroscience, eye care, virology, women's health, and gastroenterology.

AbbVie Careers

Joining AbbVie means becoming part of a global team dedicated to making a remarkable impact on patients' lives. At AbbVie, our employees are united in the pursuit of groundbreaking innovation and are committed to transforming the future of healthcare with leading-edge science.

Work You’ll Do

At AbbVie, you’ll collaborate with some of the brightest minds in the industry to solve challenging problems that have a high impact on society. Our culture fosters growth and embraces leadership and diversity training, ensuring that every team member can thrive.

Explore Job Opportunities

AbbVie offers a wide range of job opportunities and career paths, providing a platform where professionals can propel their careers forward. From research and development to marketing and sales, the potential to make a significant impact is limitless.

Internship Programs

Kickstart your career with an AbbVie internship. Our programs provide invaluable industry experience and a chance to develop essential skills in a real-world setting. Interns at AbbVie are considered integral members of the team and are given tasks that are both challenging and rewarding.

Professional Growth and Development

We believe in nurturing our team's professional growth through comprehensive training programs, leadership development opportunities, and continuous learning. Our commitment to your career growth is reflected in our robust offerings that enhance your skills and knowledge.

Benefits and Culture

AbbVie is dedicated to supporting our employees' well-being both inside and outside of work. Our benefits package includes health, financial, and social benefits that are designed to support the diverse needs of our employees. Our inclusive culture encourages collaboration and innovation, fostering a workplace where all can excel.

Hiring Process

Our hiring process is designed to ensure a match that will be beneficial both for the company and for your career aspirations. From resume submission to interview, each step is an opportunity to showcase your skills and fit with the AbbVie team.

Networking and Career Advancement

At AbbVie, networking doesn’t just enhance your career; it propels it. We encourage our employees to engage internally and externally to build relationships that foster personal and professional growth.

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Explore AbbVie Jobs

Whether you’re seeking to advance your career in a dynamic and empowering environment, or looking for a place where you can innovate, lead, and contribute to something bigger, AbbVie is the place for you. Join us in our mission to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow.
Learn more about AbbVie
Size
50,000 employees
Market Cap
$288.5 billion
Industry
Pharmaceuticals & Biotech
Net Income
$4.6 billion
Founded
2013
5 Year Trend
+17%
Revenue
$45.8 billion
NASDAQ
ABBV
* Ladders Estimates

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