573 Pharma jobs in the United States

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 . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok . Job Description Purpose: The Product Development Science & Technology (PDS&T) Toxins group within AbbVie Operations - Biologics organization supports manufacturing, process validation, regulatory submission, and continuous improvement for late-stage and commercial manufacturing of biological toxins products in AbbVie. We have an exciting opportunity for a Principal Research Scientist I position based in Irvine, CA. The Pharma Principal Scientistwill support extended physicochemical characterization of late-stage and commercial neurotoxin programs for regulatory filings including new BLA submissions and life-cycle management of approved products. The candidate must have demonstrated in-depth knowledge and experience in structural characterization including but not limited to physicochemical, separation, and mass-spectrometry techniques to support late-stage and commercial pipeline assets. Responsibilities: Manage the efficient and comprehensive transfer of prior knowledge from senior members of the team, various AbbVie sites, and contract development and manufacturing organizations. Centralize the knowledge within a digital system to ensure it is accessible, well-organized, and ready for effective future use. Design and execute extended physicochemical characterization, forced degradation, critical quality attributes (CQA) determination, structure-function relationships, elucidation of structure (EOS), reference standard qualification, and comparability of drug substance for late-stage biologics and neurotoxin pipeline programs. Interpret data from different characterization experiments to identify key structural attributes. Provide analytical support for process development, manufacturing, as well as DS/DP testing Author standard operation procedures, study protocols and reports, CMC analytical sections of BLA and relevant CMC regulatory packages pertaining to structural characterization. Respond to and resolve technical questions from regulatory agencies pertaining to regulatory submission sections. Identify and drive continuous innovation initiatives, implement new laboratory technologies, and enhance fundamental product/process understanding that will contribute to scientific improvements of pipeline projects. Train and mentor staff team with appropriate instrument techniques and serve as senior technical advisor. Partner closely and effectively with diverse groups within function and maintain strong working relationships with internal, and external collaborators. Qualifications B. S, M.S, or Ph.D in Biochemistry, Analytical Chemistry, Pharmaceutical Sciences, or closely related field with typically 14+ (BS), 12+ (MS) or 6+ (PhD) years of industry related experience. Eligibility and ability to work with select agents in accordance with all relevant safety and compliance regulations . Demonstrated hands-on experience in protein physicochemical characterization techniques such as Circular Dichroism, Differential Scanning Calorimetry, Analytical Ultracentrifugation, Spectrophotometry, Intrinsic fluorescence, Light Scattering, Binding Kinetics is required. Expertise in separation based HPLC (IEX, SEC, RP), gel and capillary electrophoresis (SDS-PGE and CE-SDS), mass spectrometry (intact mass, peptide mapping), and cell-based potency methods is a plus. Prior experience in designing and executing forced degradation studies, CQA determination, and structural characterization by physicochemical, separation, mass spectrometry, and potency methods in a BLA submission is highly desirable. A strong publication track record in the field of biologics and extensive knowledge in protein biochemistry is required. Ability to author internal/external peer-reviewed publications and patents is a plus. Prior experience in mentoring and leading a team of laboratory scientists is a plus. Excellent interpersonal and oral/written communication skills, technical presentation skills, critical thinking, and problem solving is required. Ability to demonstrate and execute detail-oriented work and working in a matrix cross-functional environment is required. Must have a “results-oriented” work ethic and a positive “can-do” attitude with a strong sense of urgency, self-motivated, and the ability to lead a team to achieve common business goals. Ability to maintain strong relationships with peers and cross functionally with collaborating partners to enable higher team performance is required. Embracing diversity in ideas and perspective from direct reports and team members, providing constructive feedback, and resolving conflicts to create a respectful working environment is highly desirable. Additional Information Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law: The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture. We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical/dental/visioninsurance and 401(k) to eligibleemployees. This job is eligible to participate in our short-term incentiveprograms. This job is eligible to participate in our long-term incentiveprograms Note: No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Company’s sole and absolute discretion, consistent withapplicable law. AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer/Veterans/Disabled. US & Puerto Rico only - to learn more, visit US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more: #J-18808-Ljbffr

This is a hybrid position, local candidates only.

Description:
This individual will work in the Global Quality System & Strategic Transformation organization supporting global projects and initiatives. Activities include all aspects of project management for Drug Shortage Prevention Plans (DSPP), creation of deliverables, working with stakeholders and driving technical enhancements. The individual will directly work with the Global Quality Risk Management team and be responsible for establishing and maintaining records. DSPP work involves active collaboration with a cross-functional team in manufacturing sites, external manufacturing, regulatory, supply chain, product quality, compliance, and other global functions. This global function includes monitoring, tracking, and supporting various efforts and initiatives in the Quality System.

Responsibilities:

• Lead meetings to facilitate and/or support the DSPP Project.
• Actively collaborate with a cross-functional team to complete project milestones and DSPPs per
• established timeline.
• Assist the functional areas on completing the DSPP risk factors and input in the DSPP.
• QA review of DSPP content in compliance with established governing documents.
• Oversee, monitor and track key deliverables associated with DSPP Implementation Project Metrics and
• related initiatives.
• Support other DSPP Project deliverables or initiatives as requested.

• Bachelor's degree in Chemistry, Pharmacy, Biology, Microbiology, Engineering, or other technical/scientific area.
• Minimum of 5 years of experience in Quality Assurance and/or Quality System oversight. Risk Management, supply chain, compliance and drug shortages experience preferred.
• Lead meetings with technical professionals and experience in leading cross-functional teams with a results-orientated approach.

• Knowledge of regulatory documents such as ICH, US / EU and other key GMP regulations.
• Skills: Result-oriented, strong oral and written communication skills, excellent interpersonal skills,
• initiative, attention to details, time management in a fast-paced environment, teamwork, problem solving
• and project management.
• Computer system skills including Microsoft Office; proficient in Power Point and Excel.