Cell Biology and Pharmacology

Program Director, Regenerative Medicine Programs (Job Code: 3508)

The Associate Program Director/Program Director, Regenerative Medicine will be responsible for guiding the development of a subset of Geron’s Regenerative Medicine therapeutic programs. This person will lead a multidisciplinary team of Geron personnel from research, product development, manufacturing, clinical development, operations, and senior management to formulate and articulate the strategies for development of hESC-derived therapeutic cell types from preclinical development through clinical development. The program director will provide key strategic oversight to the program, including setting priorities, developing resourcing plans and budgets, and anticipating problems and working with project teams to solve or deflect them. This person will serve as a project manager for Geron’s Regenerative Medicine therapeutic programs working to coordinate research, preclinical development, product development, manufacturing and clinical development activities to meet project milestones and timelines. (S)he will also work in close coordination with Geron’s business development and legal groups to assure appropriate business partnerships and contracts are executed, and with Geron’s intellectual property group to assure freedom to operate. This person will also be responsible for working with senior management and the project teams to formulate project timelines and milestones.

Requirements:

Lead Geron's multidisciplinary team to formulate and implement Geron’s strategies to advance therapeutic programs from preclinical development through clinical development.
Work with senior management and project teams to develop project timelines and goals; provide project management support for the achievement of these goals.
Through constant communication with project team members in research, product development, manufacturing, quality, regulatory, preclinical, clinical and other functions, maintain a high level of awareness of ongoing project activities across functional groups.
Integrate cross-functional understanding of ongoing and planned project development activities to anticipate and deflect resourcing issues, timeline incompatibilities, technical challenges, and other potential project issues.
Provide ongoing planning and operational support to project activities and objectives. Lead project team meetings; prepare project team minutes.
Working with project team members from functional areas, lead development of program budgets.
Prepare and deliver written and oral project updates for senior management, board of directors, and external parties.
Work with business development to coordinate completion of contracts and other legal documents to execute workplans and projects.
Work with Geron’s legal team to file and prosecute Geron’s intellectual property and to execute freedom to operate searches.

Qualifications:

The candidate must have at least 5-7 years experience in the biotechnology and/or pharmaceutical industry, and a broad familiarity with multiple disciplines in the development of pharmaceutical products. Experience in coordinating multidisciplinary groups is a must; experience with products in early clinical development is preferred.
The candidate must have a strong technical background in the biological and/or medical sciences, and a powerful intellectual curiosity to learn about new fields. A Ph.D. in the biological sciences and/or an M.D. degree is strongly preferred.
The candidate must have a strong strategic grasp of the regulatory and technical challenges associated with the development of a biological therapeutic, and an ability to integrate information from multiple sources to develop implications and action plans.
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 must have a collegial personality and excellent oral and written communication capabilities. He or she must be able to interact with a broad range of scientists, physicians, and business professionals both within Geron and externally.
The candidate must thrive in a team-oriented entrepreneurial environment.

Scientist I/II (Job Code 6108/6208)

The scientist in the cell technologies group will be responsible for devising and conducting experiments to assess the composition and function of human embryonic stem cell therapy products. This position will also be responsible for the development of assays for use by manufacturing and quality teams.

Responsibilities:

Develop methods to characterize heterogeneous cell populations. This includes developing and applying screening methods to products in our clinical pipeline.
Uncover molecular markers and develop tools to assess the potency of cell therapeutics.
Identify molecular targets and develop assays for in-process monitoring of the production of clinical candidates.
Participate in developing novel methods to eliminate impurities from cell therapy products.
Must remain engaged with progress in the field, through both the literature and meetings in order to bring creative energy to challenging scientific questions.
Collaborate with R&D and analytical development teams as necessary to translate research findings into useful analytical tools.

Requirements:

Ph.D. in cell biology / biochemistry with 3 -5 years post-doctoral work experience and a successful publication record. Biotech / pharmaceutical industry experience a plus.
Demonstrated hands-on experience with one or more of the following molecular techniques including real - time quantitative PCR, immunocytochemistry, FACS, and ELISA-based assays.
Experience with human embryonic stem cell culture and/or primary cell culture.
Experience with medium to high throughput cell-based assays a plus.
Demonstrated experience with micro array analysis and bioinformatics a definite plus.
Ability to critically evaluate and troubleshoot complex problems is essential.
The candidate should possess strong interpersonal skills, including strong oral and written communications skills, and be able to thrive in a team oriented entrepreneurial environment.

Product Development - Cell Therapies

Temporary Research Associate II (Job Code 5908T)

We are seeking a highly motivated and qualified Research Associate II to join our Regenerative Medicine program for approximately 6 months. His/Her main responsibilities will be to participate in experiments and technical studies to develop robust, scaleable cell culture methods that are suitable for clinical manufacturing of Geron's cellular therapies.

Responsibilities:

Culture and differentiate human embryonic stem cells.
Participate in experiments and technical studies to support development activities.
Design and execute experiments, analyze and present data.
Perform general lab duties such equipment maintenance, monitoring, calibration and cleaning.

Qualifications:

BS/MS in life sciences, physical sciences or equivalent.
2-3 years of industrial work experience desired, preferably obtained in the biotech industry.
Must have a strong focus on quality, attention to detail, and results, especially in the area of diligent and timely completion of documentation.
Strong interpersonal, communication and problem solving skills are required as well as demonstrated ability to work effectively in cross-functional teams.
Experience in mammalian cell-culture required.
Hands-on experience with cell-based assays such as flow cytometry and immunocytochemistry and real-time PCR preferable.
Must be flexible and willing to work weekends, holidays as needed.

Product Development & Manufacturing - Oncology

Development Associate, Process Development and Manufacturing (Job Code: 5308)

The Development Associate will be a skilled synthetic organic bench chemist in the Geron Oncology Group. This primary purpose of this position is to develop, optimize and analyze synthetic reactions in support of Geron’s telomerase activation program.

Responsibilities:

Assist process development and manufacturing activities for the Geron Telomerase Activation Program (primary responsibility)
Perform Routine laboratory work such as synthesis of target compounds, analysis of samples, API and drug product.
Conduct experiments as needed to advance the program.
Utilize statistical software such as Design Expert as appropriate.
Prioritize and handle variety of tasks simultaneously
Record and maintain lab notebooks with detail and clarity.
Maintain a clean, organized and safe working area in the lab.
Write protocols and reports as necessary to document the results.

Skills Required:

BS/MS in Chemistry with a minimum of 2-5 years experience in synthesis of small molecules and/or oligonucleotides/nucleosides.
Experience in synthetic organic chemistry especially in heterocyclic and coupling reactions.
Experience in NMR, HPLC, MS, UV and interpretation and presentation of the results to the team.
Must be able to work independently and as a team member.
Proficiency in Word, Excel, PowerPoint, ISIS draw or ChemDraw preferred.
Outstanding written and verbal skills as well as problem solving skills required.
Familiarity with GMP practices and knowledge of CFR, ICH guidelines desirable.
Must be a demonstrated team player with experience in contributing to multi-disciplinary project teams and ability to work with minimal supervision.
Strong initiative and ability required to work in a fast-paced, dynamic environment.

Clinical Pharmacology

Senior Research Associate II / Scientist I - Clinical Pharmacology (Job Code 5408)

Job Description:

We are currently seeking a Senior Research Associate II / Scientist I to join our DMPK group to help support the discovery and development of novel small molecule therapeutics. The successful candidate will be responsible for drug metabolism and pharmacokinetics studies and will participate on multidisciplinary teams to contribute to Geron's drug discovery and development efforts. The candidate should be experienced and proficient in developing and performing robust bioanalytical methods to support in vivo and in vitro drug metabolism and pharmacokinetics in lead selection and drug development. Job responsibilities include but not limited to:

Perform bioanalytical assays on non-clinical PK/ADME samples.
Perform pre-clinical in vitro ADME assays, e.g. metabolic stability in microsomes, plasma, and hepatocytes, CYP inhibition and induction, plasma protein binding, and metabolite identification.
Hands-on experience with state-of-the-art bioanalytical equipment and methodology (HPLC, LC/MS/MS, and robotic liquid handler) is a must. So is the ability to troubleshoot instrumentation related issues independently.
Experience with different sample preparation techniques, e.g. SPE and LLE.
Keep abreast of the scientific literature.
Participate in department meetings and present data.

Minimum Qualifications:

MS degree in biopharmaceutical sciences, biochemistry, biology, chemistry or related discipline with 5+ years relevant industrial experience in DMPK, or Ph.D. degree with 1-2 years of industry experience.
The candidate should be self-motivated, detail oriented, fast learner, proactive in problem solving, meticulous in record keeping and documentation, and able to manage timelines and priorities.
The candidate should be able to work both independently and as part of a team, and have a desire to learn new methods and to work on new assignments.
The candidate should have good interpersonal skills, and effective written and oral communication skills.
Experience in GLP regulations and environment is preferred.

Sr. Scientist - Pharmacology, TA Therapeutics (Job Code 5508)

Provide leadership for the development, qualification and validation of in vitro and in vivo pharmacology systems and efficacy models to support Geron's preclinical development of telomerase activator biopharmaceuticals for regenerative medicine. Design, evaluate, and execute optimized pharmacology test models and systems for efficacy and pharmacodynamic biomarkers in nonclinical samples and in vitro and in vivo model systems. Initiates, directs and executes all pre-clinical scientific research and/or development strategies in research and/or development. Investigates the feasibility of applying a wide variety of scientific principles and concepts to potential inventions, products and problems. Plans and executes laboratory research, compiles reports and contributes to IND-enabling studies to support go/no go decisions for TA Therapeutics development candidates. Maintains broad knowledge of state-of-the-art principles and theories specifically related to telomerase biology and age related pathologies, including fibroproliferative disorders, cardiovascular, wound healing, immunological and bone-related diseases. Makes major contributions to scientific literature and conferences. May act as spokesperson on corporate research and development and advise top management. May participate in development of patent applications. Interfaces with various departments, establishes scientific collaborations with external groups and serves as internal consultant.

Requirements:

Ph.D. degree in cell biology, biochemistry or relevant biological discipline, 5-8 years post-doctoral/academic work experience in the telomere biology or age-related disease fields with a successful publication record. Biotech / pharmaceutical industry experience a plus.
Technically innovative, with demonstrated experience in applying a broad range of pharmacological methods to develop and validate in vivo and in vitro bioassays in relevant disease models.
Technical expertise in vitro and in vivo pharmacology assays and familiar with molecular and cellular techniques, such as quantitative PCR, FACS, and immunoassays.
Ability to critically evaluate and troubleshoot complex problems is essential.
Capable of working independently and in a self-directed manner with minimal guidance.
Ability to be flexible and able to adapt to changing project priorities and timelines.
Well-organized and detail-oriented professional, with effective verbal and written communication and interpersonal skills.
Ability to prepare IND-level pharmacology reports and summaries on relevant data sets generated on development candidates.
Demonstrated ability to collaborate productively in a team environment.

Senior Research Associate II/ Scientist - Assay Development/Preclinical (Job Code 5608)

Join Geron as an integral member of the oncology pre-clinical development department. Major responsibilities will be conducting in vitro and in vivo experiments elucidating the mechanism of actions of Geron proprietary telomerase inhibitors and support clinical development of the drug molecules. Responsibilities also include development of new xenograft tumor models and assays to for the preclinical development of the telomerase inhibitors.

Qualifications:

MS degree/Ph.D degree in cell biology, cancer biology or relevant discipline, 5-10 years/2-5 years work experience in the biotechnology or biomedical research field
Demonstrated hand-on experience with cellular, molecular and biochemical assays
Track record of innovation, problem solving and original thinking
Self-motivation and pro-active attitude is a must
Knowledge and experience in telomerase biology and/or cancer biology is a plus
Demonstrated organizational skills
Proficient in computer software (Excel, ImageQuant, Prism or equivalent) to perform data analysis and graphing
Effective interpersonal and technical communication skills
A track record of constructive team player

Clinical Operations

Manager, Oncology Clinical Operations (Job Code: 3708)

The Manager assists the Oncology Clinical Operations staff with operational activities for new and ongoing clinical trials. The goal of Oncology Clinical Operations is to conduct clinical trials according to regulatory requirements and SOPs, within the budget and timelines.

This position reports to the Director Oncology Clinical Operations.

Specific Duties:

Manage study activities, including investigator recruitment and selection, study start-up, enrollment, data collection, drug projections, and reports
Manage study sites and train clinical site staff to ensure protocol and regulatory compliance
Responsible for CRO selection, development of RFPs, budget negotiations, and CRO management
Responsible for clinical site budget and contract negotiation
Responsible for writing study protocols, monitoring plans, study reports, sections for Investigator's Brochures, and regulatory documents (e.g., IND, NDA or BLA)
Interact with investigators and thought leaders for protocol development, presentations and publications
Coordinate and participate in investigator meetings
Manage program budget and timelines
Mentor and develop junior staff
May be responsible for managing staff
May be responsible for ensuring SOP and regulatory compliance of staff

Requirements:

Bachelor's degree in a relevant scientific discipline or equivalent
At least 8 years of relevant clinical experience in the pharmaceutical industry or equivalent
Knowledge of GCP and ICH guidelines required
Excellent communication and interpersonal skills
Detail oriented
Able to problem solve and use good judgment
Able to work within a team
Able to work with general instructions
Proficiency with MS Word, Excel, Outlook, and PowerPoint
Must be willing to travel as required for the project

Senior Biostatistician (Job Code: 2508)

The Manager of Biostatistics will develop statistical methodology appropriate for the analysis of clinical studies utilizing knowledge of statistical literature and regulatory agency guidelines. This person will serve as the primary liaison for statistical issues and questions with regulatory authorities. Additionally, this person will work with the Biostatistics Director in writing Statistical Analyses Plans & SAS programming plans for Phase I and Phase II clinical studies.

Essential Responsibilities:

The person in this position will plan/implement/review biostatistical components of clinical trials including any or all of the following:

Contribute to protocol development by choosing an appropriate study design and statistical methodology, defining endpoints, calculating necessary sample size to achieve a pre-specified power, and writing the statistical section of the protocol;
Develop or review the statistical analyses plan;
Review case report forms (CRFs) and ensure their design meets the protocol criteria and captures all data required to support a high quality database and the planned analysis;
Generate and review randomization schedule(s);
Participate in project teams as Biostatistics representative;
Establish and negotiate accurate timelines with internal and external team members and Biostatistics management for completion of study-related biostatistical activities;
Perform plausibility checks on data and take the appropriate action to resolve inconsistencies and to handle implausible values during analysis;
Generate or review and approve tables, listings, and figures (TLFs) in collaboration with statistical programmers to ensure accurate and appropriate analysis and results;
Conduct and participate in validation and quality control of project deliverables as necessary;
Perform diagnostic tests of model adequacy;
Perform statistical analysis and prepare corresponding sections of the research report, with responsibility for review of entire research report;
Ensure proper study closeout by documenting and archiving study related materials;
Provide input to SOP development and review when necessary.

Minimum Requirements:

Candidate should have an MS or a Ph.D. in Biostatistics or closely related field.
Candidate should have a minimum of 6+ years experience in clinical trial biostatistics.
Must have excellent knowledge in statistical theory and implementation including standard and novel experimental design, categorical data analysis, analysis of variance (covariance), survival analysis, non-parametric methods.
Experience in SAS programming is required.
Must be familiar with ICH guidelines and other regulatory requirements related to biostatistical activities.
Candidate should possess excellent written and verbal communication as well as strong interpersonal communication skills.
Statistical experience within a team or company with an Oncology focus is desirable as well as experience in later stage clinical trials.

Medical Director (Job Code: 2208)

The Medical Director directs clinical development activities for a new chemical entity. The individual will manage and be responsible for overseeing the direction, planning, execution and interpretation of clinical trials/research and data collection activities.

Essential Responsibilities:

The Medical Director establishes and approves scientific methods for design and implementation of clinical protocols, data collection systems and final reports. Will recruit clinical investigators and negotiate study design and costs. Responsible for directing clinical trials Phases I-III and will be repsonbile for adverse event reporting, medical monitoring and safety activities. Contributes to clinical development strategy including feasibility analysis; Defines project standards and determines allocation of studies to countries based on strategic needs and available capacity; Collaborates with clinical team, study leaders, statistician, data managers, regulatory and other members from diverse disciplines as needed; Serves as focal point for clinical project communications with senior management; Represents clinical program at critical decision points; Represents program at key meetings with Regulatory agencies

Key components of this position including but not limited to:

Must have well developed leadership and project management skills in directing clinical development activities for pharma/biotech, including demonstrated success in communication, interpersonal, influence, and financial management skills; Demonstrated originality in problem solving as applied to drug development and have skills and experience dealing with government officials in the U.S. and abroad; Scientific and technical expertise, including the ability to develop robust clinical plans covering all phases of drug development; Financial skills and administrative experience in budgeting and managing internal and external expenditures across multiple countries.

Skills and Attributes:

Candidate must be a Board Certified/ eligible MD in oncology or hematology with at least 3+ years of direct and focused experience in the design, implementation and management of clinical studies.

Regulatory Affairs and Quality

QC Analyst II/III (Job Code 6008)

The QC Analyst II/III will provide technical support for Geron's Regenerative Medicine QC Group.

Responsibilities:

To perform routine analysis on incoming raw materials using compendial and in-house test methods.
To support environmental monitoring programs for Geron's cGMP facility. Maintain EM database.
To execute protocols using approved QC Test Methods in support of the development, qualification, validation and tech transfer of analytical methods for the characterization of Geron's embryonic stem cell products.
To perform Flow Cytometry assays, bioassays, immunoblotting, Taqman PCR, ELISA and SDS-PAGE.
To support other programs for Geron's cGMP facility and various QC databases.

Qualifications:

The candidate must have a bachelor's degree in biology, biochemistry or equivalent with 2-5 years of industrial experience in analytical development/QC for biologics and/or cell therapy applications.
The candidate must have a working knowledge of GLP, GMP, and regulatory guidelines.
Experience in other analytical techniques such as electrophoresis and/or HPLC is desirable.
Hands-on experience with ELISA, SDS-PAGE, FACSCalibur is desirable.
Good organization skills and attention to details are a must.
Work well independently as well as within a group

Quality Engineer (Job Code: 1108)

This position reports into the Director of Quality Assurance and provides primary support to the company’s programs, GRNVAC1, GRN163L, and GRNOPC1. The QA Engineer supports all GLP/GMP equipment, facility and utility systems validation, and is responsible for the implementation and management of the Geron’s Quality change control program. Additionally, the QA Engineer will support other aspects of Geron's Quality Systems such as supplier qualification and internal audits.

Responsibilities:

Support the management and implementation of Geron's Change Control program in accordance with regulatory requirements, current Good Manufacturing Practices (cGMPs), and Geron's standard operating procedures.
Provide QA and validation guidance in the development, review and approval of process, software, equipment, utility systems, and laboratory instrument validation/qualification.
Review and approve validation/qualification packages including installation qualification, operation qualification, and performance qualification (IQ, OQ, PQ) protocols and reports.
Host routine meetings with Manufacturing, Operations, Quality Control and Bio-Analytical Laboratory to review proposed changes to qualified processes, equipment/utility systems, and approved procedures and specifications related to GLP/GMP operations.
Evaluate process and test equipment qualification/validation requirements.
Review and support investigation of equipment out-of-tolerance.
Interact routinely with Geron equipment vendors/contractors to provide QA guidance and assure compliance to Geron procedures.
At the request of QA management, write, review and approve standard operating procedures, technical documents, and production records and data including but not limited to: method transfer packages, BPRs, QC stability and release data, etc.
Support other aspects of quality system as needed.
Help ensure overall compliance to Geron's quality standards, procedures and policies.

Qualifications:

Bachelor’s or Master’s Degree in a relevant scientific discipline with combined 5+ years demonstrated QA and validation experience in early to late stage (pre-IND to Phase I/II) biotechnology companies.
Demonstrated knowledge of GXP compliance regulations and industry practices, and demonstrated experience in implementing quality assurance systems in a GMP regulated environment.
Prior experience in managing and implementing change control.
Must be detailed oriented with good organization and time management skills.
Strong verbal and written communication skills required.
Ability to effectively participate on multi-disciplinary teams.