Job opportunities.

Senior Scientist

This individual will be responsible for the pharmacological evaluation of novel therapeutics to treat diabetes, dyslipidemia, obesity and other related metabolic disorders. Responsibilities will include establishing and validating relevant disease models, developing in vivo/ex vivo pharmacodynamic markers suitable to drive structure activity relationships and provide pharmacological evaluation of test compounds in relevant disease models. This individual will organize and supervise work of a small group of scientists and summarize and communicate results both to internal and external customers as needed.

• Ph.D. with 2-4 years experience or equivalent relevant experience (MS with at least 10 years relevant experience or B.S. with at least 15 years experience) in life sciences or related medical/scientific field.
• Relevant biotechnology or pharmaceutical industry experience.
• Strong record of publication.
• Solid scientific background with a general understanding of discovery and drug development processes and interdependencies.
• Strong interpersonal, collaboration-building and conflict-resolution skills.
• Prior experience managing senior B.S./M.S. level scientists.
• Advanced written and oral communication skills.
• Advanced prioritization and organizational skills that allow management of multiple responsibilities and tasks.

Investigator/Associate Director

The individual in this position will be responsible for lead identification and preclinical/clinical in vitro assessment of compound mechanism. Specifically, this individual will oversee the development, validation, and implementation of novel biochemical/cell-based assay formats and technologies for small molecule lead discovery and characterization in multiple therapeutic areas, including Metabolic Diseases, Pain, and Inflammation. In addition, the individual will be responsible for the development of in vitro biomarker assays for the assessment of compound effects from human clinical samples. The individual will supervise at least one Ph.D. level and four B.S/M.S. level scientists associated with the structure-based drug design, assay development/ultra-high throughput screening, and clinical biomarker teams. This scientist will be required to work intimately in large, multi-disciplinary discovery and development teams, to report data in written and verbal format to the senior scientific management team in the relevant forums, and to interface with alliance partners.

• Minimum Ph.D. with 8-10 years experience or M.S. with 12- 15 years experience in life sciences or related medical/scientific field.
• Relevant biotechnology or pharmaceutical industry experience.
• Strong record of publication.
• Solid scientific background with a general understanding of discovery and drug development processes and interdependencies.
• Must be experienced with current methods in molecular cloning, protein expression and purification, biochemical/cell-based assay development.
• Must have familiarity with screening automation including liquid handlers and readers
• Strong interpersonal, collaboration-building and conflict-resolution skills.
• Prior experience managing both Ph.D. level and senior B.S./M.S. level scientists.
• Advanced written and oral communication skills.
• Advanced prioritization and organizational skills that allow management of multiple responsibilities and tasks.
• Experience in ultra-high throughput screening systems and/or structure-based drug design is preferred.

Support Scientist

Kalypsys' informatics group develops software to support drug discovery, including ultra-high-throughput assays, chemistry, biology, and analytical chemistry. We acquire, create and deploy software that enhances scientific quality, throughput, and originality. Meeting these objectives simultaneously is challenging. Our systems must be robust. Software must prevent inaccurate information from being recorded, yet be flexible to support evolving science. Active communication with scientist-users, as well as consistent testing and curation make our objectives attainable. To increase our strength in these areas we are recruiting a support scientist.

• Train scientists to use informatics software
• Test new and modified software
• Curate database content, working with scientists and programmers to correct redundant, incomplete, or incorrect information
• Help scientists find information and adapt existing tools to new scientific processes
• Maintain informatics web area with links to common tools, help pages, etc
• Manage bug and feature requests. Help prioritize requests based on experience helping scientists

• At least a B.S. in biology or chemistry with bench experience
• Strong computer skills including experience with Excel, web database applications, and data analysis software
• Ability to learn quickly and invent solutions or work-arounds, but also to follow instructions precisely when necessary
• Be a patient teacher
• Handle details, with habits to check and double-check work

Research Associate

Responsibilities will include assessment of efficacy of novel therapeutics for metabolic diseases (diabetes, dyslipidemia, atherosclerosis and obesity) using a variety of in vivo animal models and ex vivo biochemical and/or molecular biological techniques. This will involve drug administration, behavioral observations as necessary, collection of tissues and/or body fluids for measures of drug efficacy and utilization of surrogate biomarkers of response. To this end, standard molecular biology and biochemistry techniques such as protein extraction, Western blotting, immunohistochemistry, gene expression and lipid biochemistry will be used to reveal both drug response and mechanism of action. Experience in islet isolation and hyperinsulinemis/euglycemic clamp studies in rodent models is a plus. The incumbent will have, expertise in experimental design, conduct, analysis and summarization of data, ability to effectively communicate results to project teams and contribute to project reports on a need basis.

• BS/MS in Pharmacology/Biology/ Behavioral Pharmacology, or related fields
• Minimum 2-4 years industry/academic experience in Molecular Pharmacology with an emphasis on evaluation of efficacy of test compounds
• Direct animal handling experience with demonstrated proficiency at various routes of dose administration, blood and tissue collection and appropriate biochemical assay expertise.
• Experience in preclinical animal models (establish and maintain) is essential.
• Enthusiastic team player with good communication skills and energy to operate with minimal supervision in a fast-paced environment.
• Familiarity with statistical analysis of data is required

Senior Scientist, Pain & Inflammation

The position will involve coordinating and conducting drug discovery research on specified targets and/or pathways in the therapeutic areas of pain and inflammation in collaboration with other members of the organization. The position may involve directing one or more research associates in the design and development of assays for primary and secondary screening of relevant targets (biochemical & cell-based), to characterize lead chemical series in biological assays, and to provide biology support to multidisciplinary drug discovery and preclinical development teams. Individual will report data in written and verbal format to senior scientific staff in relevant corporate and scientific forums.

Senior Scientist position requires the following minimum background combination of educational/job experiences:

• PhD degree in Molecular Biology, Cell Biology, Biochemistry or related field with 2-4 years relevant industry experience or postdoctoral training
• Prior training and direct experience in biology and pharmacology of pain targets and pathways is required, prior experience in GPCR targets is preferred
• Individual must be familiar with current methods in molecular biology, cloning, enzymatic and cell-based assays, biochemistry, protein expression and purification
• Prior direct management experience (associate/technician level) is preferred
• Excellent communication skills are expected including: technical writing skills, PC skills, and supervisory skills. Conducts all business activities in accordance with Kalypsys core values including high personal integrity, commitment to quality results, and encouraging a team-oriented environment.

Scientist

• Kalypsys, Inc. of San Diego, CA has an immediate opening for a Scientist to work in collaboration with a team of analytical scientists in a multi-disciplinary problem-solving environment.
• The successful candidate will be responsible for the elucidation of chemical structures of pharmaceutical interest, with particular focus on metabolite profiling of drugs in biological matrices from nonclinical species and human.
• Successful job performance includes the development and trouble shooting of appropriate extraction and purification techniques, method development and problem solving of HPLC and strong MS/MS interpretation skills.
• The successful candidate will inspect and analyze complex datasets, communicate results through written reports and oral presentations to matrixed project teams.
• Additional challenges will include the development of a database to enable data access and archival.
• In addition, the position provides the opportunity to contribute to general problem solving in the qualitative analysis of trace mixtures for impurities and degradants using custom technology developments.
• Other desirable attributes include a familiarity with automation, an appreciation of technology transfer and a working knowledge of the overall drug discovery and development process.

• The successful candidate will have a B.S. or M.S. in Analytical Chemistry or related field with a minimum of 6-8 years or 3-6 years respectively of relevant experience.
• Experience with quantitative data analysis and interpretation is a strong advantage.
• Experience with HPLC instrumentation, triple quadrupole mass spectrometers and liquid handling systems is required.
• A demonstrated ability to work well in a team environment and have the flexibility to succeed in a dynamic and rapidly growing work place is a must.
• An ability to identify, develop and implement technology solutions is considered a plus.
• Creative and innovative problem solving and excellent oral and written communication skills are required.

Associate Director/Director, Quality Assurance

• Provides management oversight of the Quality organization at Kalypsys.
• Establishes the proper environment to assure that there is a quality focus in all activities of the business.
• Leads the Quality Department in establishing the systems and procedures necessary to assure cGMP compliance.
• Responsible for recruiting and managing members of the Kalypsys Quality Department.
• Provides compliance expertise and guidance, interprets FDA and ICH drug regulations and guidelines and provides leadership to maintain compliance.
• Stays abreast of regulatory expectations, including technological advances and changes in industry standards.
• Oversees the establishment and maintenance of Kalypsys' controlled documents including SOPs, and product specifications.
• Oversees the establishment and maintenance of a comprehensive and effective cGMP quality system at the Kalypsys designed to meet Kalypsys policies and standards. Elements include, but are not limited to, batch disposition, change control, deviations, corrective and preventive actions, validation, materials management, and training.
• Responsible for proactively identifying potential quality problems and issues with related outside suppliers, manufacturers and laboratories through Compliance audits Due Diligence visits and routine site visits.
• Responsible for making effective written and oral presentations of Quality activities, including reports of audit findings and appraisals.

• MS Degree in life sciences or a comparable discipline with a minimum of 10 years relevant industry experience
     OR
  BS Degree in life sciences or a comparable discipline with a minimum of 15 years relevant industry experience
• Pharmaceutical company and/or FDA experience in Quality Assurance and/or regulatory compliance roles. Experience in managing outside contractors and suppliers that are operating in a regulated pharmaceutical environment.
• Excellent working knowledge of cGMP regulations, ICH and EMEA Guidelines and the fundamentals of Quality Assurance.
• Experience handling quality issues in a pharmaceutical development environment.
• Strong decision making skills and the ability to use and analyze data as required.
• Excellent communication skills including: technical writing skills, PC skills, supervisory skills, and negotiating skills with all levels of personnel, departments, and outside resources.
• Conducts all business activities in accordance with Kalypsys core values including high personal integrity, commitment to quality results, and by encouraging a team-oriented environment.

Senior Scientist

We are currently seeking a highly motivated developer to help build and expand our suite of informatics tools. A successful candidate will be a strong leader, an independent problem solver, a creative thinker, is able to articulate their thoughts in a group setting and stays current with the latest advances in Java and web technologies. The candidate must write superior-quality code and play a significant role in software architecture, planning and management of projects. Strong emphasis is placed on cheminformatics and computational chemistry. Experience with chemically intelligent systems and pharmacological data is a plus.

• Ph.D. in Chemistry or another physical science.
• Extensive software development experience with emphasis on web design and development.
• Mastery of Java and related technologies, as well as SQL.
• Experience with cellular biology, the pharmaceutical industry, or chemistry in particular is preferred.
• Experience with Spotfire, and Pipeline Pilot is valuable.
• A strong grasp of mathematics and statistics.
• Communication and presentation skills are critical.

Associate Director

The Associate Director (AD) position will be responsible for leading multiple development teams as Project Leader. The AD will effectively bridge the Discovery and Translation Medicine functions of the company, facilitating seamless progression of projects through the Kalypsys Stages and Gates. The Associate Director will contribute to global program management initiatives and should be flexible and opportunistic in taking on new challenges in a fast-paced small company environment.

Performs the following tasks independently:

• Serve as Project Leader for multiple Translational Medicine teams:
  • Collaborate with and guide teams in the creation, maintenance and execution of strategic development plans that are aligned with the scientific and business objectives of the company;
  • Ensure development program conduct is consistent with regulations, guidelines, and policies;
  • Ensure projects are executed on time and within budget, with appropriate adjustments as needed;
  • Represent the team within and outside the company;
  • Resolve issues and conflicts;
  • Organize and manage team meetings
• Contribute to the ongoing improvement of program management systems and processes.
• Interface with representatives from key functional groups (R&D;, Manufacturing, Commercial, Regulatory Affairs, and Clinical) to drive cross-departmental initiatives.
• Ensure appropriate resources and priorities are maintained for all projects.
• Oversee and mentor Project Managers, and perform other department management roles as needed.
• Assist in due diligence processes as needed.
• Performs personnel related supervisory duties (e.g., performance assessments, development of staff goals and objectives).
• Perform other duties as assigned.

• Ph.D. or M.S. in life sciences or related medical/scientific field.
• 8+ years relevant biotechnology or pharmaceutical industry experience.
• 3+ years in small molecule-based pharmaceutical program management.
• Thorough understanding of drug development processes and interdependencies
• Strong interpersonal communication, conflict resolution and team building skills.
• Advanced written and oral communication skills.
• Proficiency with MS Project and MS Office.
• Cost-center/budget management experience.
• Advanced prioritization and organizational skills that allow management of multiple responsibilities and tasks.
• Personal character consistent with the Kalypsys Values