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Kalobios is currently hiring for the following positions:
Associate Director/ Director, Regulatory Affairs
Description
The Associate Director of Regulatory Affairs is a hands-on position responsible for overseeing regulatory submissions/communications with health authorities and for ensuring operational compliance to regulations for development programs. This person will have a both a strategic and a directional role and must be well-organized, an effective communicator, and capable of performing critical assessments on complex issues of corporate importance.
Job Responsibilities:
Regulatory project team representative with responsibility for providing guidance and addressing issues on how to effectively communicate with health authorities, as well as how to satisfy applicable regulatory requirements.
- Serve as a liaison with regulatory authorities for assigned projects
- Oversee timely preparation (including actively writing documentation) of scientifically valid submissions that are compliant to health authority requirements
- Manage change control of R&D documentation consistent to regulatory filings
- Provide regulatory oversight of development activities to ensure compliance to health authority law, regulation, and guideline
- Establish and maintain compliance programs and systems
- Work with Quality and other departments to ensure data accuracy and integrity relating health authority reporting requirements
- Participate in corporate partnership efforts
- In concert with Quality, host regulatory authority inspections
- Oversee GxP training programs
- Assist in budget forecasts and management
Education & Experience:
A minimum of a BS in a scientific field is required (advance degree a plus) along with 8+ years in regulatory affairs in biotechnology with experience in monoclonal or biologics.
Knowledge & Skills:
- Solid background in general biological/physical science and a proven ability to apply that knowledge to complex regulatory issues and the writing of submissions
- Experienced with regulatory authority interactions and requirements, especially State of California, FDA, and EMEA
- Proven ability to proactively work cross-functionally on development teams
- Demonstrated proficiency of how to effectively satisfy regulatory law, regulation, and guidance in a start-up company
- Proven ability in creative problem solving and the ability to eliminate roadblocks to development
- Highly productive team member capable of knowledgeable contribution and influence management
Compensation:
KaloBios offers an excellent total compensation package including competitive base pay, bonus, excellent benefits and stock options.
Please submit your resume and inquiries to HR at careers@kalobios.com.
Senior Scientist, Antibody Expression
Position Summary
The successful candidate will be responsible for the generation of mammalian cell lines and E. coli expression systems for the production of KaloBios Humaneered™ antibodies.
The position is part of the Research Department with close interactions with members of the Development group and externally with contract research organizations and manufacturers. It provides the opportunity to have a major impact on the development of KaloBios’s pipeline of therapeutic products and to contribute to the discovery of new methods for the efficient generation of recombinant proteins from a variety of different expression systems.
Primary Responsibilities Include:
- Generation of highly productive transfectant cell lines expressing recombinant antibodies suitable for transfer to a contract manufacturer.
- Vector construction using state-of-the-art expression systems.
- Development of novel expression systems for recombinant antibodies in mammalian cells.
- Development of bacterial expression systems for the efficient expression of humaneered antibody Fab fragments by secretion from E. coli.
Requirements:
- PhD in molecular biology, cell biology, biochemistry or a related discipline
- At least 7+ years experience in a research function in the biotechnology or biopharmaceutical industry
- Expert knowledge of expression systems for the production of recombinant proteins from eukaryotic and prokaryotic cells
- A thorough understanding of recombinant antibodies and antibody structure
- An understanding of cell-line development for the production of antibodies suitable for therapeutic use, including requirements for cell-line testing, appropriate record-keeping and other regulatory requirements.
Please submit your resume and inquiries to HR at careers@kalobios.com.
Director/Senior Director Quality
Position Description
The Director/ Senior Director of Quality is a hands-on position responsible for leading the QAU function with the company. This person will direct the company’s quality activities and initiatives, assure the quality of products and processes, and ensure the highest integrity in quality compliance. Experienced candidates in this position should be able to work effectively in a small company environment, build an organization to meet corporate and drug development objectives, and work with a team to effectively support multiple therapeutic programs and teams.
Job Responsibilities:
- Develop and manage an effective cGMP quality system that is aligned with the needs of a virtual company
- Perform the role of the QAU (as mandated under cGMP) for the company, including overseeing the product release testing, performing product disposition, and setting product retest/expiry dating; inventory management may be a part of the job responsibilities from time to time
- Develop short-term and long-term goals and procedures that meet the organization’s quality objectives that are consistent with cGMP compliance for US, Canada, Australia, Europe, and other major regions
- Actively participate in project team meetings to represent Quality and to direct incorporation of Quality into development activities
- Interface with FDA and other regulatory agencies
- Manage the company’s document control and records management system
- Provide input into the development, improvement, validation, and troubleshooting for QC analytical testing and raw material release, batch release, and environmental monitoring
- Oversee, develop, and maintain validation documents (e.g. , master plans, protocols, change controls, summary reports, etc.)
- Provide leadership, as well as work in close coordination with others, to effectively support the company’s project teams
Education and Experience:
- Minimum of 10 years experience managing QA/QC operations in a Phase 1-2 environment in the biotechnology/ pharmaceutical drug industry
Knowledge and Skills:
- Proficient working knowledge of cGMP for FDA, Canada, Europe, Australia, and other major regions
- First hand experience in managing early and substantial growth in a Quality Organization
- First hand experience in managing quality compliance for work conducted by third party service providers
- Broad regulatory, cGMP/SOP, audit background along with a background managing validation efforts and writing validation protocols
- Must be a dynamic leader with outstanding communication, strategic and collaboration skills, and provide the organization with a vision to be facile and adept at balancing work leading teams
- Track record in creative problem solving and the ability to eliminate roadblocks to development
Please submit your resume and inquiries to HR at careers@kalobios.com.
Research Associate, Protein Biochemistry Group
Position Summary
KaloBios Pharmaceuticals is a dynamic private biopharmaceutical company with a unique technology for identifying human antibodies and a pipeline of antibody-related products. KaloBios is seeking a highly motivated Research Associate with experience in protein biochemistry to contribute to the purification and characterization of antibodies, Fabs and other proteins.
Primary Responsibilities:
- Purification of Antibodies, Fabs and proteins suitable for biochemical, cell biology and animal studies
- Analytical characterization of purified proteins that will include purity test, protein identification, endotoxin level measurements and protein stability
- Study protein-protein interactions by using ForteBio, gel filtration, and other techniques
Requirements
- BS in Biological Sciences with 5 or more years of relevant experience or MS with 3 or more years of relevant experience
- Extensive experience with protein purification on AKTA systems using a variety of protein purification resins
- Experience with protein production for preclinical studies
- Excellent organizational, written and verbal communication skills
- Ability to work in fast-paced environment, independently and within a team
Please submit your resume and inquiries to HR at careers@kalobios.com.
Research Associate, Cell Biology
Position Summary
KaloBios Pharmaceuticals is a dynamic private biopharmaceutical company with a unique technology for identifying human antibodies and a pipeline of antibody-related products. KaloBios is seeking a highly motivated research associate with experience in cell-based assays to contribute to the identification and characterization of novel antibody-based therapeutics. The position provides the opportunity to contribute to the development of KaloBios’s pipeline of therapeutic products in a highly interactive research environment.
Primary Responsibilities:
- Evaluation of engineered antibodies in in vitro functional assays, such as ELISA, cell proliferation, cytotoxicity and apoptosis assays.
Requirements
- BS/MS in Biology, Biochemistry, Molecular Biology or a related discipline with minimum of 2 years of relevant experience in a research environment in the biopharmaceutical or biotechnology industry
- Experience in mammalian cell culture techniques
- Candidate must demonstrate the ability to develop new functional assays, perform in highly interactive team environments and possess good written and verbal communication skills
- Familiarity with Excel, Word and Powerpoint software and the ability to utilize a variety of software programs for data analysis are required.
Please submit your resume and inquiries to HR at careers@kalobios.com.
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