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 Twitter, Facebook, Instagram, YouTube and LinkedIn.

Job Description

The PDS&T Global Material and Parenteral Packaging group within Operations Science & Technology organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological products at AbbVie. We have an exciting opportunity for a Scientist I based in Irvine, CA and are seeking a highly motivated Scientist I to join in our team and lead project activities related to the design, evaluation and implementation of Container Closure System (CCS) development for AbbVie’s early- and late-stage parenteral Antibodies, Antibody-Drug Conjugates as well as Eye Care and Neurotoxin products. The ideal candidate will independently manage CCS characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug product and combination products requirements.

Responsibilities:

• Planning, preparation, execution and evaluation of experiments for development of container closure systems for new parenteral drug products, namely liquid drug preparations of biotechnological drugs in vials, pre-filled syringes and cartridges as well as lyophilizates.

• Evaluation and implementation of testing methods for CCS with a focus on continuous improvement and adherence to Regulatory requirements.

• Responsibility for assigned laboratory equipment. Ensure required maintenance, documentation, and user training.

• Authoring comprehensive, scientifically sound reports that could serve as source documents for authority submissions.

• Collaboration with third party labs and/or manufacturing sites.

• Coordination of suppliers for materials, equipment, and services.

• Documentation of all work according to applicable GSP or GMP and internal procedural requirements.

• Supporting continuous landscaping programs for innovative CCS, implementing and characterizing new CCS techniques.

• Presentation of project data as well as SME topics in internal global teams.

• Interacting professionally and effectively with peers and management within AbbVie.

Qualifications

• Bachelor’s Degree or equivalent education with typically 5 years of experience, or Master’s Degree with typically 2 years of experience in Analytical Chemistry, Material Sciences, biomedical, Chemistry, Physic, or related fields, preferably with Master’s degree.

• Experience in CCS qualification and characterization, with hands-on experience in CCS test method development and validation.

• Good technical and scientific understanding of parenteral drug product development and regulatory guidelines.

• Ability to develop comprehensive test plans and evaluate design concepts to ensure CCS meets stakeholder needs.

• Ability to effectively identify and communicate risks.

• Understanding of relevant scientific literature and ability to apply theoretical framework to solving problems within scientific discipline in a timely manner.

• Detail oriented and good track record in delivering reliable and consistent results.

• Working knowledge of regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials and drug/device combinations products is desired.

• Scientific expertise in statistical data analysis is a plus.

• Able to work with cross functional teams including R & D, Science & Technology, Operation, Quality, Regulatory, etc.

• Excellent oral communication skills as well as sound technical writing and documentation competencies are required.

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

Salary: $71,000 - $134,500

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: immunology, oncology, neuroscience, eye care, virology, women’s health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio.