Director or Sr. Manager – 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 an expanding company. We are an equal opportunity employer.
The Company: Object Pharma owns Clostridium botulinum serotypes A through G and 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’re looking for a Director or Sr. Manager of Process Development and Manufacturing to lead a group responsible for process development and GMP manufacturing of clinical material. The ideal candidate will bring a diverse set of skills to implement strategies for development work, process improvement, facility design and improvement, GMP manufacturing of drug substance (upstream and downstream,) and aseptic drug product manufacturing (fill-finish).
- Must have experience working with therapeutic biological products.
- Lead a team of multiskilled researchers to develop and manufacture biopharmaceutical drug substance and drug product for therapeutic use working in a BSL2 enhanced or 3 environment.
- Expected to perform hands on work in process development and manufacturing environments.
- Develop and execute protocols for purification of proteins from conditioned media or extracts of microbial extracts.
- Perform and 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
- 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, Molecular Biology, Biochemical engineering, or a related field with 15 years of experience in process development and GMP manufacturing.
- Ability to lead and 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 HPLC and FPLC, and various chromatography methods such as reverse phase, ion exchange and hydrophobic interaction chromatography.
- Experience with separation methods used in protein purification, such as filtration, diafiltration and concentration and precipitation.
- Experience with and knowledge of current protein detection and characterization techniques like SDS-PAGE, ELISA, mass spectrometry, UV, visible and fluorescence spectrophotometry, capillary electrophoresis, and chromatography methods.
- Experience in writing SOP’s, batch records, research reports, data analysis, 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 and develop and manage reports. Set goals and evaluate the progress of reports against measured goals.
- Physical ability to work regularly 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.