Group Leader/Associate Director, Preclinical Development (Job Code 4809)
This person will direct the activities of the preclinical development group to promote animal efficacy and safety testing of candidate therapeutic products derived from human embryonic stem cells. Studies in animal models for cardiovascular, endocrine, central nervous system and skeletal diseases are anticipated. This person will both manage and have hands-on responsibility for the design and execution of preclinical animal studies including data analysis and report writing.
Responsibilities:
Direct and actively participate in scientific studies to address proof of concept and safety testing of Geron's human embryonic stem cell based products in animal models. Studies will be performed internally, as well as with contract and academic research laboratories.
Manage and coordinate activities of the preclinical group to address the needs of multiple development programs.
Select and manage CROs as necessary for project needs.
Provide functional and technical management to scientific personnel within the group.
Perform data analysis and generate reports, including those for regulatory filings.
Write and review manuscripts for publication.
Collect, interpret, discuss and present data for project teams, senior management, and externally, as appropriate.
Represent the preclinical group in project teams to help design studies to meet program goals and provide coordination across groups.
Work with clinical development teams to design and execute animal studies to address specific medical needs of Geron's products.
Maintain an up-to-date understanding of scientific developments within related fields.
Coordinate preparation of progress reports and internal documentation.
Qualifications:
The ideal candidate will have a Ph.D. in Pharmacology or a related field, with a minimum of 10 years post-doctoral experience.
The candidate will have demonstrated managerial skills with previous experience in a management role in the biopharmaceutical industry desirable.
Experience conducting physiological, behavioral and anatomical efficacy measures using preclinical models of disease is required.
Direct experience with animal surgery is required.
The candidate must be detail oriented and highly conscientious. He or she must have strong organizational skills, and a well-developed ability to multi-task.
The candidate should demonstrate successful prior direction of complex, interdisciplinary projects and participation in project teams; familiarity with biologics preferred.
The candidate must have excellent communication capabilities and presentation skills.
The successful candidate will be able to work independently, as well as contribute to an integrated team. He or she must be able to interact with a broad range of colleagues within Geron.
Previous experience with preparation of regulatory submissions and familiarity with GLP regulations are desirable.
The candidate must be willing to travel, occasionally for periods up to 2-3 weeks.
Geron is developing human embryonic stem cell (hESC) technology to create cell based therapies for the treatment of human degenerative diseases. The Director of Islet Cell Biology will lead a team of scientists and research associates to improve methods to differentiate hESCs into pancreatic islet cells and test these cells in both in vitro and in vivo animal models of diabetes. This position will also be responsible for leading scientific efforts to differentiate other endodermal cell derivatives for both therapeutic and drug discovery applications.
Responsibilities:
Direct provide strategic scientific and technical leadership to a team of researchers to develop human embryonic stem cell therapeutics for diabetes
Develop protocols to improve the efficiency of differentiating islet cells and their progenitors from hESCs
With preclinical development department, lead efforts to test differentiated islet cell populations for their efficacy and safety in appropriate animal models of diabetes
Interface with collaborating scientists and physicians to develop and execute workplans to improve differentiation schemes, test preclinical safety and efficacy, and develop efficient delivery systems for hESC-derived islet cells
Interface with product development personnel to scale production of differentiation protocols for cGMP manufacture
Provide project plans and timelines
Write reports on scientific studies to support regulatory submissions
Present scientific findings to key scientific, administrative and business forums
Qualifications:
Ph.D. in cell biology/ biochemistry/developmental biology with 5-10 years experience in islet cell biology and diabetes models
A working knowledge of islet cell developmental biology a must
Goal oriented individual with a positive track record in management of scientific staff
Experience in cellular and molecular therapy preferably in a biotechnology or pharmaceutical setting a definite plus
Proven experience in pancreatic differentiation and pancreatic biology a definite plus
Experience in cell culture, cellular and molecular assays to determine differentiation of stem cells
Excellent oral and written communications essential
Product Development - Cell Therapies
Process Engineer, Manufacturing Sciences (Job Code 2410)
This Process Engineer will provide technical support to programs within Geron's Manufacturing Sciences group relating to manufacturing, preparation and delivery of human Embryonic Stem Cell (hESC)-derived cell therapy products. This work will involve executing and documenting the development of methods in this field of study. It may also involve the implementation of methods at multiple locations other than Geron's Menlo Park facility and comprehensive technical oversight of these facilities.
Responsibilities:
Participation in experiments designed to optimize manufacturing processes for hESC-derived cell therapy products
Participation in lean analysis of manufacturing processes for hESC-derived cell therapy products
Participation in the development of improved container closure systems for hESC derived cell therapy products
Participation in experiments designed to optimize or qualify hESC-derived cell therapy product preparation processes
Participation in experiments designed to test hESC-derived cell therapy product delivery
Participation in the technology transfer of hESC-derived cell therapy product processes, materials and equipment into Geron's Pilot and cGMP manufacturing facilities as well as outside manufacturing, clinical and non-clinical organizations
Participation in qualifying and training clinical and non-clinical site cell processing laboratories in the preparation of hESC-derived cell therapy products
Participation in preparation of hESC-derived cell therapy products for pre-clinical studies
Interact closely with other department within Geron, including but not limited to Process Sciences, Manufacturing Operations, Quality Assurance, Quality Control, Clinical Operations and Regulatory Affairs
Write and review development reports, Standard Operating Procedures (SOPs) and other quality related documents
Perform activities in accordance with current Good Practices (cGXPs)
Qualifications:
A BS/BA in life sciences, physical sciences, engineering or equivalent is required with at least 5 years of industrial work experience
Experience in aseptic and/or cell-culture operations in an industrial or clinical environment is required
Experience in data analysis using JMP is preferred
Experience in design of experiments (DOE) is desired
Experience in process improvement or process development is desired
The candidate must be prepared to travel as much as 30% of the time
Must have a strong focus on quality, attention to detail, and results
Strong interpersonal, communication and problem solving skills are required as well as demonstrated ability to work effectively in cross-functional teams both internally at Geron and externally at outside organizations
Experience in the creation and revision of Standard Operating Procedures (SOPs) is desired
Produce Embryonic Stem Cell derived cell therapy product under cGMP conditions
Interact closely with Operations, Quality Assurance, Quality Control and Product Development
Perform all activities in accordance with current Good Manufacturing Practices (cGMP)
Perform equipment monitoring, maintenance, calibration and cleaning
Qualifications:
BS/BA in life sciences, physical sciences or equivalent
0 - 2 years of industrial work experience desired
Must have a strong focus on quality, attention to detail and results
Strong interpersonal and communication skills are required as well as deomstrated ability to work effectively in cross-functional teams
Experience in cell culture operations in a cGMP environment is preferred
Working knowledge of aseptic technique, safety, quality systems, and quality assurance concepts preferred
Must be flexible and willing to work weekends, holidays and staggered weekdays, as needed
Senior Development Associate, Manufacturing Sciences and Pilot Production (Job Code 2710)
As part of the Manufacturing Sciences group, the Senior Development Associate assists the Manager, Pilot Plant, in overseeing pilot production of human embryonic stem cell based therapies. Additional responsibilities may include material and personnel resource management and forecasting, Technology Transfer, LEAN analysis, as well as participation in pilot studies. The Senior Development Associate will closely collaborate with other Product Development departments, viz. Process Sciences, Analytical Development and Manufacturing Operations, as well as with R&D and QA/QC.
Responsibilities:
Oversees Pilot Production of human embryonic stem cell based therapies
Manages material and resource allocation for Pilot Production, Pilot Studies, and Technology Transfer projects
Maintains strict segregation of multiple projects within the Pilot Laboratory
Executes LEAN manufacturing principles
Maintains Pilot Laboratory (equipment monitoring and maintenance, calibration, cleaning and related documentation)
Writes and reviews development reports, SOPs, Technology Transfer documents and other quality related documents
Trains personnel as required
Participates in, plans and designs experiments to optimize processes, scale-up and reliability
Participates in and executes Technology Transfers
Due to the nature of cell culture, the candidate must be willing to adopt a flexible work schedule
Qualifications:
BS/BA in life sciences/engineering with a minimum 5-8 years of industrial work experience
Must have experience in cell-culture and aseptic technique
Must have a strong focus on quality, attention to detail, and results
Strong interpersonal and communication skills are required
Must have excellent computer skills including MS Word and MS Excel
Working knowledge of safety, quality systems, and quality assurance concepts is required, including an understanding of current Good Manufacturing Practices (cGMPs) as they apply to bioprocess manufacturing
Experience in the creation and revision of Standard Operating Procedures and Manufacturing Production Records is strongly desired
Experience in or aptitude in lab management desired
Experience in process improvement or process development desired
Geron Corporation, an industry leader in Oligonucleotide based therapeutics, is seeking a motivated Ph.D. level candidate to join their microRNA therapeutics team. The post-holder will join Geron on a 2-year contract, renewable after successful completion of the first year and will be permitted the opportunity to publish data in high-quality, peer-reviewed scientific journals.
This exciting position entails basic and translational research with the objective of identifying and potentiating a microRNA oncology target. We are seeking a talented and enthusiastic researcher with proven background in cancer research to join our team. Expertise in handling and manipulating animal cell culture and in-vivo models, nucleic acid and protein analysis techniques and Immunohistochemistry are required. Experience with microRNA biology is a plus. Scientific passion and intellectual curiosity, good verbal and written communication skills are a must. This position offers exposure to Geron?s talented scientific pool and excellent scope for scientific growth.
Clinical Operations
Clinical Scientist (Job Code 2610)
Geron Corp. is building a high quality clinical development organization to design and execute its oncology programs. We are currently seeking a clinical scientist (Medical Director/Senior Medical Director) with drug development experience in biotech/pharma to join the Oncology division.
Responsibilities:
Job duties and responsibilities are initially focused, but not restricted to, the design, implementation, analysis and interpretation of clinical trials from phase I-III
Additional details are available upon request
The position reports to the Executive Medical Director
Qualifications:
Candidate should have an M.D. with board certification/eligibility in hematology/oncology
Candidates with Ph.D./PharmD with at least 3 years of drug development experience in industry will also be considered
Prior experience in an oncology related field is strongly preferred
Candidates must be strategic, comfortable proactively solving issues, and working independently
Excellent technical understanding of oncology, excellent technical understanding of the clinical trial process and in particular the role of the Medical Monitor, including compliance requirements, ICH etc
A high level of competency in written and verbal communication skills
Ability to work well as part of multi-disciplinary teams are also important
Geron is committed to providing equal opportunities for all those with the desire to succeed
Regulatory Affairs and Quality
Regulatory/GCP Coordinator or Manager, Oncology (Job Code 1310)
This position will support Geron's Oncology project teams in the planning, electronic document preparation, and electronic submission of all Oncology regulatory submissions following regulatory guidelines and internal processes within required timelines. This position will also support the development and preparation of documents for Geron's compliance with Good Clinical Practice (GCP) regulations. Depending upon prior experience he/she may serve as the primary liaison with regulatory authorities and manage regulatory interactions for his/her assigned project(s). This position reports to the Vice President of Oncology Regulatory Affairs.
The successful candidate will have prior experience in either Regulatory Affairs or GCP and have very well developed computer/software skills as well as the ability to quickly learn essential aspects of the area in which they do not have prior experience. The ideal candidate will have direct experience in preparation and maintenance of electronic controlled quality or regulatory documents.
Responsibilities:
Collaborate closely with Geron Oncology management and project teams to prepare and manage project timelines for completion of regulatory submissions in accordance with project and corporate goals.
Serve as a Regulatory Affairs/GCP representative on selected project teams and enhance the progress of projects and probability of success by providing operational regulatory/quality support throughout the product lifecycle.
Prepare, format and maintain electronic library of regulatory submissions to support the Geron Oncology Program. Depending upon prior experience, provide advice on content, review and assembly of regulatory documentation and manage submission of regulatory documentation for INDs, amendments, BLAs, NDAs, supplements, etc.
Prepare and maintain electronic library of Good Clinical Practice (GCP) documents to support the Geron Oncology Program. Depending upon prior experience, provide advice on content, review and preparation of GCP Quality Plans, GCP Audit plans and reports. Depending upon prior experience, identify the need for written procedures within GCP and coordinate the development and preparation of Clinical Oncology SOPs.
Qualifications:
Bachelor's degree in computer science or other scientific discipline
For Manager, 4+ years relevant experience in the pharmaceutical or biotechnology industry
For Coordinator, 2+ years relevant experience in the pharmaceutical or biotechnology industry
Demonstrated track record of success in the preparation of either regulatory submissions or quality documents
A strong understanding of discipline appropriate FDA and ICH Guidelines
Ability to identify and proactively solve problems
The ability to work effectively with limited supervision in a project team environment
Excellent written and verbal communication skills
Excellent interpersonal and collaborative skills
Strong organizational and project management skills
Very strong computer and word processing skills
Experience with the preparation and formatting of documents for electronic regulatory submissions
