Principal Scientist – Process Development and Manufacturing
Object Pharma is a biotech company located in Aliso Viejo, California, with GMP facilities in Madison, Wisconsin. Object is developing novel neurotoxin products for aesthetic and therapeutic applications. We offer our employees competitive compensation, a flexible, fast-paced environment, and the opportunity to learn a diverse skill set in a growing company.
The Company: Object Pharma has a pipeline of neurotoxin candidates that will expand the clinical application of neurotoxins.
- Our employees have the unique opportunity to develop broad expertise in a small, inclusive company.
- We believe that every member is critical to building a strong company and generating superior products.
The Position: We are looking for a Principal Scientist of Process Development and Manufacturing to lead those activities in the production of clinical material. The ideal candidate will bring a diverse set of skills to implement strategies for process development, process improvement, process characterization, GMP manufacturing of drug substance (upstream and downstream) and aseptic drug product manufacturing (fill-finish).
- Work with a team of multiskilled researchers to develop and manufacture biopharmaceutical drug substance and drug product for therapeutic use.
- Develop new processes for GMP production of biologics and for manufacturing by GMP standards.
- Develop and execute protocols for purification of proteins from conditioned media or extracts of microbial extracts.
- Develop and implement protocols for microbial fermentation processes.
- Identify, develop, and implement analytical methods for drug substance and product to meet specifications for in-process testing and release of GMP material.
- Manage and perform work in Biological Safety Level (BSL) 2 and 3 environments.
- Work with other team members to implement requirements and documentation to meet cGMP standards.
- Train team members to work in a GMP environment and adhere to GMP requirements.
- Develop and implement documentations such as batch records, protocols, scientific reports, and SOP’s for manufacturing and safety.
- Crosstrain in relevant areas and train other laboratory members in various tasks.
- Be a team player capable of working closely with people across disciplines to troubleshoot scientific work.
- Perform other duties assigned from time to time.
- Identify and implement new technologies for development and manufacturing of therapeutics.
- A Ph.D. in Biochemistry, Microbiology, Biochemical engineering, or a related field with 7 - 10 years of experience in Upstream and or Downstream process development and GMP manufacturing for biotherapeutics.
- Ability to work with a talented team of professionals to implement company and project goals.
- Hands-on experience in the development of expression and purification of proteins from microbial cultures and the production of protein therapeutics in a GMP environment.
- Hands-on experience with development and optimization of microbial culture processes for GMP production of protein therapeutics.
- Hands-on experience with chromatography techniques, including membrane-based separations, HPLC and FPLC, and various methods such as reverse phase, ion exchange and hydrophobic interaction chromatography.
- Experience with filtration methods used in protein purification, such as depth filtration, diafiltration and concentration, charged based filtration and protein precipitation methods.
- Experience with and knowledge of current protein detection and characterization techniques like SDS-PAGE, ELISA, mass spectrometry, UV, visible and fluorescence spectrophotometry, and capillary electrophoresis methods.
- Experience in writing SOP’s, batch records, research reports, data analysis, and investigation reports (CAPA).
- Team player with demonstrated willingness to learn new skills across relevant specialties to fit the broad needs of a small biotechnology company.
- Ability to mentor, develop, and manage reports.
- Physical ability to work routinely in a laboratory environment, including walking/standing for long periods of time, using standard laboratory equipment, using standard office equipment, and lifting up to 40 pounds.
- Employees must pass a background check and receive CDC approval to work with Select Agents and toxins and must be willing to work with botulinum toxins. Previous CDC approval is an advantage.
The Location: This position is located at Object Pharma in Madison, Wisconsin.
Equal Employment Opportunity
Object Pharma is an Equal Opportunity employer and will consider all qualified applicants for employment without regard to any legally protected characteristic in compliance with U.S. and State of Wisconsin employment laws.