Allergan Sr Scientist, Biologics Development in Irvine, California
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. For more information about AbbVie, please visit us at www.abbvie.com . Follow @abbvie on Twitter at https://twitter.com/abbvie , Facebook at https://www.facebook.com/AbbVieGlobal , Instagram , YouTube at https://www.youtube.com/user/AbbVie and LinkedIn at https://www.linkedin.com/company/abbvie .
Envision working with energetic colleagues and inspirational leaders. Now, place yourself in that mix; leading discussions, asking the right questions and driving results.
WhatYour New Manager Wants You To Know
The Sr. Scientist will lead, oversee and support biologics drug product formulation & process development, scale-up, technology transfer, process validation and manufacturing from pre-clinical/clinical stage through regulatory approval and product commercialization. Specifically, the candidate will lead formulation development of liquid, lyophilized and prefilled syringe biologic and neurotoxin products. The candidate will also develop drug product manufacturing processes and transfer these processes to internal and external clinical and commercial manufacturing sites. Additional responsibilities may include reformulation or developing alternative drug delivery systems or drug product manufacturing processes for marketed biologic and neurotoxin products as part of commercial product life-cycle innovation. These activities will be in conjunction with an overall cross-functional Chemistry, Manufacturing, and Controls team that is required to develop and successfully execute coordinated project plans, budgets, and timelines.
The position requires the individual to work in areas requiring select agent access. Access to and use of select agents is regulated by Federal policies. Violation of or failing to support the intent of select agent polices, regulations or laws can result in substantial fines and/or imprisonment, as well as civil monetary penalties and are considered grounds for dismissal.
YOU ARE more than just a title, YOU ARE…
A strategic thinker : align and excite internal stakeholders to facilitate success through strong leadership, strategic thinking and personal drive.
Firstclass team player : collaborate across multiple disciplines to ensure compliance and ability to influence cross-functional teams and senior leadership.
Design formulation studies to optimize liquidand lyophilized formulations for proteins, peptides, monoclonal antibodies,toxins, viral vectors, live bacterial therapeutics, cell and gene therapies.
Develop and transfer drug product manufacturingprocesses to clinical and commercial manufacturing sites including processscale-up, characterization and validation.
Author drug product development Chemistry,Manufacturing, and Controls sections of IND, IMPD, BLA, and MAA.
Review and author technical documents includingformulation & process development reports, manufacturing records,validation protocols/reports, and technology transfer reports.
Represent Biologics Product Development functionat project team meetings and work closely with cross-functional team members todevelop the overall CMC strategy, identify critical path activities andtimelines, as well as ensure coordinated project execution.
Ph.D. level educationpreferably in pharmaceutical sciences, biochemical/chemical engineering,biology, chemistry or other related scientific field and a minimum of fouryears of industry experience with a strong, proven record of success in developingbiologics and neurotoxin drug products or at least seven years with an M.S.
Significant experiencewith biologics formulation & drug product development, scale-up, technologytransfer, process validation, CMO oversight, authoring drug product CMCregulatory sections, IND, IMPD, BLA, MAA filings and responding to healthauthority questions.
Experience working withneurotoxins is highly desirable.
Must have understandingand knowledge of the applicable global regulations, cGMP, ICH guidelines,and Quality Systems.
Will work with potentneurotoxins or Select Agents, therefore be able to comply with Federal and thecompany’s select agent polices, regulations and laws.
A working knowledge anddemonstrated application of global regulatory expectations involving Quality byDesign principles, Design of Experiments and application of relevantstatistical analysis is desirable.
Demonstrated scientific excellence and effectivecommunication through scientific presentations and published articles inpeer-reviewed journals.
In this role, we’re looking fora leader who will :
Act as an Owner
Be Excellence Focused
Act as an Influencer
Equal Employment Opportunity
At AbbVie, we value bringing together individuals from diverse backgrounds to develop new and innovative solutions for patients. As an equal opportunity employer we do not discriminate on the basis 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, protected veteran status, or any other legally protected characteristic.