Principal Research Scientist I, Analytical R&D (LAI)

Job Description

We are seeking a highly motivated, experienced analytical scientist to impact early phase development of New Chemical Entities (NCEs) in both drug substance and drug product throughout the preclinical and clinical lifecycle.

This role will focus specifically on the analytical development of long-acting injectable (LAI) delivery systems. In relation to LAIs, the candidate should have expertise in applying general analytical principles and regulatory guidelines within an R&D environment.

The candidate will need experience in analytical control strategies, analytical method development, characterization, validation, release, and stability testing.

He / She should be able to direct research and / or project activities by effectively mentoring, guiding and / or supervising scientific personnel.

Should conceive, execute and communicate novel multi-disciplinary research or development strategies that achieve project and strategic goals.

Serve as a lead scientist on projects and contribute scientific insights into multiple other projects and initiatives.

He / she must foster productive collaborations within the global Analytical R&D organization and with R&D cross-functional partners such as Pre-Clinical Safety, Process Chemistry, Process Engineering, Drug Product Development, and Quality Assurance and Regulatory Affairs.

• Serve as the lead analytical scientist on the development of long-acting injectable (LAI) delivery systems.
• Utilize in-depth understanding of a wide range of analytical techniques to conduct research and development studies related to the development of LAIs.
• Method development, testing procedures, and implementation of analytical control strategies to help the advancement of drug discovery candidates.
• Anticipate and critically evaluate scientific or regulatory advances or competitive threats and respond with appropriate new strategies.
• Routinely demonstrate scientific initiative and creativity in research or development activities and maintain a high level of productivity in the lab.
• Generate new scientific proposals related to LAIs and lead those efforts.
• May mentor / supervise a team to support the development of NCE candidates (RSM to API to DP) from pre-clinical through Phase II clinical trials and be accountable for the effective performance of the team / individuals.
• Embraces the ideas of others, nurtures innovation and manages innovation to reality.
• Encourage ideas and drive for continuous improvement and champion initiatives within Analytical R&D and across R&D partner functions.
• Understand and comply with AbbVie safety, quality and regulatory policies and government regulations.

Qualifications

Bachelors, Masters, or Ph.D. in Pharmaceutic Chemistry, Analytical Chemistry, or related field, typically with a minimum of 14 (BS), 12 (MS), or 6 (Ph.

D.) years relevant industry experience in development of LAIs.

• Demonstrated track record in the analytical development of injectable products.
• Strong technical background in analytical chemistry, excellent analytical problem-solving skills. Capable of independently developing and troubleshoot analytical methods.
• Demonstrate creative 'out of the box' thinking to solve difficult problems and
• Champion new technologies to achieve project goals.
• In-depth experience with development of dissolution methods.
• Hands on experience with HPLC analysis and method development along with fundamental understanding and working knowledge of various analytical techniques including MS, GC, ICP-OES, IC, and NMR.
• Self-motivated, hard-working, detail-oriented individual able to work in a fast-paced team environment.
• High-quality written and oral communication skills and ability to interact effectively with interdisciplinary scientists and engineers.

Additional Information

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

• On-site position located in North Chicago
• 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.
• 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.

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.

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