Principal Research Scientist, Drug Product Development - Container Closures

AbbVie is looking for a Principal Research Scientist to lead the Irvine Container Closure Science team within Drug Product Development (DPD) for New Biologic Entities (NBE).

Direct project activities regarding 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. Independently conceive, develop, and execute all aspect of CCS characterization for Vials, Prefilled Syringes (PFS) and Cartridges to support drug product and combination products requirements.

Lead a group of Scientists by effectively mentoring, guiding, and supervising personnel. Serve as Technical Lead on his/her own project and contribute CCS insights into multiple other projects and different functional areas.

This is a key role with a direct impact on AbbVie’s exciting and rapidly growing portfolio of combination products, with a major focus on Eye Care and Neurotoxins products.

Responsibilities

• Evaluate and develop new materials and/or alternate packaging materials, packaging solutions or packaging systems, focused on sterile dosage forms, based on patient, user, and technical requirements.
• Provide technical leadership of primary packaging selection and validation, development of component specification for primary packaging components internal/external tech transfer including Life-Cycle-Management (LCM) activities.
• Provide sterile packaging technical assistance for quality and regulatory activities including preparation of technical documents for regulatory filings.
• Partner with device development team to ensure system level requirements for combination products are developed, verified, and validated in accordance with design controls.
• Develop strong cross-functional relationships with manufacturing, process development, Quality Control and Quality Assurance to enable effective resolution to technical issues and drive continuous process improvement.
• Maintain and provide expert knowledge in container closure system qualification, in-depth knowledge of regulatory requirements for container closure integrity (e.g. USP <1207>), hands-on experience in container closure integrity test method development and validation
• Expert knowledge in functional characterization of CCS, in-depth knowledge of force-based methods and optical analytical techniques
• Maintain familiarity to evolving regulatory and compendia changes and translate pharmaceutical and packaging industry trends to business opportunities.
• Excellent interpersonal skills with the ability to interact professionally and effectively with peers, management, and leadership both within and outside AbbVie.
• Excellent oral and written communication skills including the ability to create sound technical documents.

Qualifications 

Education and Experience

• MS (12+ years) or PhD degree (6+ years) in Analytical Chemistry, Material Sciences, Chemistry, Physic, or related fields, preferably with PhD degree.
• Expert knowledge in parenteral manufacturing and CCS development in either pharmaceutical, medical device or biotech industry is required.
• Significant knowledge in E&L concepts, functional CCS characterization and Container Closure Integrity analysis according to a holistic CCI strategy.
• Experience in analytical method development and validation according to USP, ICH or other compendial or regulatory requirements.
• Knowledge around regulatory requirements for parenteral pharmaceutical and biopharmaceutical products, packaging materials and drug/device combinations products expected.
• Good track record in mentoring, guiding and/or supervising of a team of scientist.
• Experiences with regulatory submissions of biotechnology drug products
• Excellent oral communication skills as well as sound technical writing and documentation competencies are required.
• The candidate must be able to work independently, respond to changing priorities and short lead times for multiple tasks; able to identify problems and work toward solutions; able to influence without direct authority in multi-disciplinary teams; must be attentive to details and have excellent organization skills.
• Can hire at Principal Research Scientist I or Principal Research Scientist II depending on experience. 

*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. 

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. 

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AbbVie 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.