Scientist Jr or Sr - Purification
Amunix Operating Inc. is seeking an experienced, hands-on individual to join our expanding team in the role of Process Scientist/Sr. Process Scientist, Purification Process Development. He/She will be responsible for the hands-on development of protein recovery and purification processes and scale-up for GMP production of therapeutic compounds based on Amunix’s XTEN®, XDC and ProTIA technology platforms. Skills required include a thorough understanding of current protein purification technologies and associated analytical methods/tools, design/optimization of experiments in support of the development of scalable protein purification processes as well as providing technical support for GMP’s and CMC strategies across the therapeutic product development cycle. Knowledge of current protein-drug conjugation techniques is desirable.
Recovery and Purification Process Optimization:
- Provide hands-on capabilities and technical expertise at bench-scale with a focus on the development of optimized recovery/purification processes for bacterially expressed proteins with an emphasis on developing robust purification technology platforms. Experience with DOE concepts and tools desirable.
- Application of in-process tools/analytical methods. Identify and implement in-process analytical tools and techniques and support refinement of analytical techniques to ensure the continuing success of active product development programs from research through clinical trials/product commercialization.
Process Scale Up:
- Provide technical expertise and support GMP scaleup efforts (multi-kg scale) aimed at the generation of optimized protein recovery processes from bacterial expression platforms that lead to sustained manufacturing consistency, robustness, scalability, increased efficiency, and reduced costs.
- Partner with Quality function to provide oversight of external GMP manufacturing activities in cooperation with contract manufacturers/ labs/partnering entities, as required.
- Provide required support to the Quality/Regulatory functions to establish, implement, maintain, and appropriately document product related process development, tech transfer, and GMP manufacturing activities.
- Prepare technical reports in support of planned regulatory submissions and future process development work.
- Support successful preparation of CMC sections of regulatory submissions, as required.
Desired Skills & Experience
- M.S. or Ph.D. in Biochemistry, Biology, Chemical Engineering, or related sciences background with 4-7 years of industry experience. Significant experience with recombinant DNA expression platforms, bacterial strain process development, protein purification, and supporting monitoring/analytical methodologies expected.
- Accomplished in bioprocess development/product development function in a biopharmaceutical/biotech company.
- Experience in scale up of protein purification processes from products expressed in bacterial strains and associated analytical methodologies.
- Working knowledge and hands-on operating experience with state-of-the-art purification development tools and in-process analytical methods/screening tools.
- Experience with research/analytical methodologies such as SDS-PAGE, ELISA, HPLC, ESI-MS, AAA, DSC, qPCR, LAL.
- Fundamental understanding and/or exposure to GMP’s desirable.
- Experience/exposure to preparation of CMC sections of regulatory submissions (IND/CTA’s) desirable.
- Strong initiative and desire to work in a fast-paced, team-oriented, dynamic environment.
- Ability to work independently and actively participate on multi-disciplinary teams.
- Strong interpersonal skills as well as excellent oral and written communication skills.
- Physical ability to lift up to 40 lbs and work at the lab bench for extended periods.
We are a biopharmaceutical company developing first-in-class products using our novel half-life extension/drug delivery platform technology. As an employee, you will be able to:
- Significantly contribute to an established company (est’d 2006) with a broadly partnered and validated technology platform which is engaged in the development of a number of novel internal pipeline molecules
- Work in a highly collaborative and motivated working environment
- Receive a comensive benefits package, including Health, Dental, Vision, Short-term/Long-term Disability and participate in matching 401(k) plans.
- Receive compensation based on candidate experience