Associate Scientist II - Bio Process Purification Development
AbbVie
Summary
As one of CMC purification development associate scientists, you will work in the CMC purification team to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite role in a lab-based function.
Job description
Role Overview
As one of CMC purification development associate scientists, you will work in the CMC purification team to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite role in a lab-based function.
Responsibilities
- Support development, optimization, and scale-up of purification processes through lab-based and scale-up lab operation activities
- Support transfer of purification processes to GMP manufacturing for clinical material production
- Execute routine purification development operations from harvest to UF/DF following established protocols and generate reliable and consistent results
- Analyze and critique experimental results, document and promptly communicate significant deviations or unexpected results
- Prepare small to large (500L) batches of buffer solutions following batch record recipe
- Support scale up lab activities including preparation and execution
- Perform routine analytical measurements using HPLC and UV-vis instrumentation
- Accurately record experimental observations and results; maintain complete, traceable data sets and batch records in electronic notebooks, databases, and Excel files
- Perform general lab maintenance including cleanliness, equipment maintenance and maintaining inventory
- Follow applicable laboratory and scale up plant safety procedures and SOPs
- Collaborate within the team to follow best practices and meet project goals
- Participate in the evaluation of novel, advanced bioprocess technologies
- Learn and understand new experimental techniques
- Author technical reports and presentations including preparing verbal updates and presentations at group meetings
Qualifications
- Bachelor's degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field, with typically 3+ years of related experience or MS degree with 0-2 years of relevant industry experience
- Must have excellent attention to detail, the ability to follow written experimental protocols and safety procedures, and the ability to maintain accurate, complete, and traceable written records
- Able to analyze and critique experimental results and note significant deviations
- Able to work collaboratively within and outside of the group
- Able to learn and understand new experimental techniques
- Has a strong understanding of bioprocess engineering concepts
- Has strong planning and analytical skills
- Has excellent interpersonal and communication skills
- Proficient in scientific writing skills and verbal communication including scientific data presentations
- Proficient in Microsoft Office and have the ability to learn new software applications
Preferred Qualifications
- Hands on experience with executing antibody or antibody-like molecule purification techniques including resin chromatography (affinity, CEX, AEX, MMC), depth filtration, virus filtration, membrane chromatography, and TFF operations
- Hands on experience with monoclonal antibody or antibody-like molecule purification at GMP, pilot and/or laboratory scale
- Understanding of analytical techniques, such as HPLC, LAL, and ELISA
- Hands on experience with high-throughput technologies and automation
Requirements
- Bachelor's degree in Chemical Engineering, Biochemistry, Chemistry, or a closely related field with typically 3+ years of related experience, or MS degree with 0-2 years of relevant industry experience
- Excellent attention to detail
- Ability to follow written experimental protocols and safety procedures
- Ability to maintain accurate, complete, and traceable written records
- Able to analyze and critique experimental results and note significant deviations
- Able to work collaboratively within and outside of the group
- Able to learn and understand new experimental techniques
- Strong understanding of bioprocess engineering concepts
- Strong planning and analytical skills
- Excellent interpersonal and communication skills
- Proficient in scientific writing skills and verbal communication including scientific data presentations
- Proficient in Microsoft Office and ability to learn new software applications
Benefits
- Paid Time Off
- Medical, Dental & Vision Insurance
- 401(k)
- Short-Term Incentive Programs
Company overview
AbbVie is a global biopharmaceutical company that discovers, develops, and markets advanced therapies for some of the world's most complex and serious diseases. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie has established itself as a leader in immunology, oncology, neuroscience, eye care, and virology. The company's flagship product, Humira (adalimumab), was one of the world's top-selling drugs for treating autoimmune conditions like rheumatoid arthritis and Crohn's disease. AbbVie maintains a robust pipeline of innovative medicines and has expanded its portfolio through strategic acquisitions, including Allergan in 2020. With research facilities across the United States and globally, AbbVie focuses on advancing science to improve patient outcomes while maintaining strong commercial operations worldwide. The company operates with a patient-centric approach and invests significantly in research and development to address unmet medical needs across multiple therapeutic areas.