||Irvine, CA United States of America
|| Biotechnology and Pharmaceutical, Computers, Software, Finance/Economics, Healthcare, Practitioner and Technician, Human Resources, Information Technology, Internet/E-Commerce, Manufacturing and Production, Science, Research & Development, Medical, Environmental, Web Technology
Associate Director, Purification (Neurotoxin & Biologics Process Sciences) |
AbbVieâs 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 peopleâs lives across several key therapeutic areas: immunology, oncology, neuroscience, eye care, virology, womenâs 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, Facebook, Instagram, YouTube and LinkedIn.
The Associate Director, downstream purification process development, will be an instrumental team member of the Neurotoxin & Biologics Process Sciences Department and its leadership team, based in Irvine, CA.Â The primary roles of this position are to lead and manage talented Scientists and Sr. Scientists of purification team and independently plan, design, and execute the experiments and develop processes to support protein expression, fermentation, and purification process development of natural and recombinant proteins (including neurotoxins) from bacterial cell cultures at various scales appropriate to stages of process development, process characterization and validation. The ideal candidate will possess strong management experience with demonstrated experience in developing processes for a broad range of biopharmaceutical products preferably based on microbial production technologies. This position is responsible for the development of experimental methods, techniques and processes by applying quality by design (QbD), scientific and/or engineering principles and statistical process design/analysis to develop robust down-stream processes. The candidate must have in-depth knowledge and proven experience including but not limited to: AKTAÂ® Pure, AKTAÂ® Ready, AKTAÂ® Pilot chromatography systems, resins screening via high-throughput liquid handling system (Tecan Evo system), ultrafiltration/diafiltration, process characterization and optimization, process scale up, scale down model qualifications and validation. This incumbent will also lead and manage research in the area of purification sciences in support of innovative process/product development both for new biological entity and life-cycle management of the product and therefore requires a strong scientific background, strong communication skill and demonstrated ability to develop biologics for clinical and commercial use.
This position presents a great opportunity to lead and manage a diverse team of scientists that support the advancement of a broad portfolio of brand therapeutics protein products. Additional responsibilities include providing leadership to the execution of drug substance development and manufacturing programs (internally or externally) in support of clinical development to successfully support IND submissions, up to BLA approvals.Â
The successful candidate is required to have proven experience of technology transfer to the global manufacturing network (internal or external) including documentation and know-how.
Furthermore, the position requires the individual to work with and in areas requiring select agents and Toxins access (i.e. Biosafety level 2 and biosafety level 3 laboratories). Access to and use of select agents is regulated by federal policies. Therefore, the candidate must conduct all work activities in compliance with Allergan internal and applicable regulatory requirements.Â Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.
Education and Experience
â¢Â PhD in Biological Science, Biochemistry, Protein Chemistry, Biochemical/Chemical Engineering or a related Life Science field with 6+ years of relevant industrial experience or MS with 10+ years of related work experience.
Essential Skills and Abilities
â¢Â Proven experience in the down-stream technologies and process development, process characterization, biochemical techniques and DOEs is required.
â¢Â Proficiency in purification equipment and bioprocess related software/application and computer operation is required.
â¢Â The successful candidate is required to have working experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMPÂ® statistical software).
â¢Â Demonstrated ability to manage and lead purification team as well as work in team environment, multitask and ensure flexibility in a dynamic environment required.
â¢Â Excellent oral and written communication skills required as is experience with documentation of experimental plans, analyzing data and generating high quality technical reports.
â¢Â Knowledge of cGMPâs, regulatory guidelines, validation practices, and other relevant regulatory requirements.
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Job Level Code
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.