Associate Director, Fermentation
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, Facebook, Instagram, YouTube and LinkedIn.
The Associate Director, Up-stream Process development, will be an instrumental team member of the Neurotoxin & Biologics Process Sciences Department, based in Irvine, CA. The primary roles of this position are to 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 neurotoxin) 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 hands-on 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 up-stream processes. The candidate must have in-depth knowledge and experience including but not limited to: fermentation process scale up, primary recovery, process characterization and optimization, scale down model qualifications and validation. This position presents a great opportunity to lead and evolve 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. This incumbent also conducts research 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. 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. Allergan internal requirements include compliance with ethics, environmental health and safety, financial, human resources, and general business policies, requirements and objectives.Key DUTIES AND RESPONSIBILITIES:
- Strong development experiences in bringing pipeline molecules from research stage to Phase I to commercial, particularly in the areas of process characterizations, tech transfers and validations to internal and external manufacturing sites.
- Direct the experimental design and execute lab-scale and scale-up process development and characterization studies and development of new products, and improvement of existing products.
- Provides timely on floor support and troubleshooting experiences in clinical manufacturing facilities.
- Well-versed in Phase I to III IND filings, analytical tests, drug substance quality assessments.
- Communicates and presents scientific and technical information within area of expertise to a cross site/cross functional audience.
- Operates effectively cross site and remote communication in a team matrixed environment.
- Possesses technical leadership supporting risk assessments (including Design Qualification, Job Hazard Assessments, Process and Quality Risk Assessments).
- Excellent writing skills for data analysis, technical protocols, technical reports and technical assessments.
- Leads and serves as a subject matter expert in specific Drug Substance, Neurotoxin & Biologics Process Science Group.
- Collaborates effectively to achieve results as an individual as well as part of a team environment.
- The Assoc. Director must complete training consistent with safety, technical, operational, process, and other skill/ knowledge requirements for the position. Maintain all training to current status. Support safety program and ensure safety in all routine and new operations by strictly following SOPs.
Education and Experience
- PhD in Biological Science, Biochemistry, Protein Chemistry, Biochemical/Chemical Engineering or a related Life Science field with 8+ years of relevant industrial experience or MS with 10+ years of related work experience.
Essential Skills and Abilities
- Proven experience in the up-stream and down-stream technologies and process development, process characterization, biochemical techniques and DOEs is required.
- Proficiency in fermentation equipment and bioprocess related software/application and computer operation is required.
- The successful candidate is required to have working experience with applying Quality by Design (QbD) concepts and statistical process design and analysis (JMP® statistical software).
- Demonstrated ability to work independently as well as in team environment, multitask and ensure flexibility in a dynamic environment required.
- Excellent oral and written communication skills required as is experience with documentation of experimental plans, analyzing data and generating high quality technical reports.
- Knowledge of cGMP’s, regulatory guidelines, validation practices, and other relevant regulatory requirements.
- This position is in Abbvie’s Irvine, CA location.
Key Leadership Competencies:
- Builds strong relationships with peers and cross-functionally with partners outside of team to enable higher performance
- Learns fast, grasps the "essence" and can change course quickly where indicated
- Raises the bar and is never satisfied with the status quo
- Creates a learning environment, open to suggestions and experimentation for improvement
- Embraces the ideas of others, nurtures innovation and manages innovation to reality
Significant Work Activities
Continuous sitting for prolonged periods (more than 2 consecutive hours in an 8 hour day)
Yes, 5 % of the Time
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.