Cell Maker Job Description Sample
Cell Processing Specialist Car-T Cell Therapy - Morris Plains, NJ
Cell Processing Specialist CAR-T Cell Therapy - Morris Plains, NJ
Novartis is a global healthcare company based in Switzerland that provides solutions to address the evolving needs of patients worldwide. Novartis recently received the first ever FDA approval for a CAR-T cell therapy for children and young adults with B-cell precursor acute lymphoblastic leukemia (ALL) that is refractory or has relapsed at least twice; a novel immunocellular therapy, a one-time treatment that uses a patient's own T cells to fight cancer, and is the first therapy based on gene transfer approved by the FDA. Therapy will be manufactured for individual patients using their own cells at the Novartis Morris Plains, New Jersey facility where Novartis continues to advance its CAR-T manufacturing expertise. The Morris Plains site plans to hire over 300 Quality, Production, Supply Chain and Bioanalytics associates in the next 10-12 months.
Due to the nature of the starting materials (patient cells) the Cell processing Specialist role requires the highest level of proficiency and ownership. The Specialist will be responsible for end to end processing and verification of patient derived clinical and commercial cellular immunotherapy products.
Specific responsibilities will include:
End to end ownership for the processing of the assigned patient starting material in the clean room environment.
Maintain and prepare equipment/environment for use.
Document all steps in the assigned Batch record in line with GMP requirements.
Conduct all necessary processing/verification steps for the assigned lot with the highest skill level of aseptic technique.
Assist on Deviation Investigations, Change Controls, Safety Inspections and CAPAs.
Perform execution of assigned qualification/ validation activities.
Be responsible for successful on time completion of a required training curriculum composed of Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs), Aseptic Techniques, Gowning Qualifications and other relevant training, including HSE for the specific role.
Perform other duties as assigned. Examples might be: successful completion of assigned PU project initiatives and/or work stream tasks, such as process improvements, efficiencies, Innovation Quality Productivity (IQP).
Maintain an "audit ready" module.
Selected associates must:
Be able to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) area for extended periods of time.
Be able to work with automated cell processing equipment such as Elutra, CS5, or Sepax.
Be knowledgeable in the use of production related IT systems such as SAP and MES.
Possess sound cell biological decision making.
Program Manager - Small Cell & Fiber Solutions
Crown Castle: Careers
Crown Castle Fiber
In your neighborhood
Outdoor Small Cell Solutions
Indoor Small Cell Solutions
Site Development Services
Landowners Help Desk
Landowners with Leases
Tower Portfolio Owners
Universities and Colleges
Theme Parks and Recreation
Stadiums and Convention Centers
Hotels and Resorts
Installations in Your Community
How Wireless Works
What to Expect
- Small Cell & Fiber SolutionsPosting Location:TX - Dallas, TX - Irving
Crown Castle works around the country to build and maintain the infrastructure behind the world's most revolutionary technologies. Crown Castle owns, operates and leases more than 40,000 cell towers and over 60,000 route miles of fiber supporting small cells and fiber solutions across every major US market. This nationwide portfolio of communications infrastructure connects cities and communities to essential data, technology and wireless service – bringing information, ideas and innovations to the people and businesses that need them. Crown Castle is an S&P 500 company and one of the largest Real Estate Investment Trusts in the United States with an enterprise value of approximately $60 billion.
Position Title: Program Manager
- Small Cell & Fiber Solutions
Responsible for directing the overall performance of DAS, small cell and/or fiber deployment projects within an assigned geographic area and for a specific product line (i.e., private, public, or fiber-only projects). Responsible for overseeing the budgets and ensuring the timely and effective completion of multiple projects of varying scope and ensuring that all of their project managers are doing the same for their specific projects, while also effectively coordinating with all of the functions (e.g., Implementation, RF Engineering, Network Real Estate, Operations, Sales, and Finance) on the assigned projects. For all projects being managed by their respective project managers, the program manager is responsible for ensuring that Crown's financial objectives are met and that Crown Castle's execution relative to external customer expectations and internal key performance metrics are achieved.
Essential Job Functions
Ensure that the project managers reporting thereto are managing the profit & loss, job cost, cash flow, contract deliverables, and increase asset yield for all of their assigned projects.
Communicate directly with customers as appropriate acting as the escalation point for customer issues. Ensure that the project teams keep customers informed of project progress, issues and projected completion dates. Develop a strong working relationship with each customer's decision- makers in order to maximize new opportunities and revenue.
Ensure deployment and customer meetings are held regularly and issues/conflicts are resolved promptly. This includes working cooperatively with district, region, and corporate teams to integrate and administer all activities to ensure customer satisfaction.
Develop and maintain working knowledge of customer contracts and customer expectations.
Monitor project status and ensure that system data are accurate, timely, and complete.
Ensure compliance with Crown Castle standard processes and procedures and Crown Castle safety requirements for all Crown Castle personnel and third party vendors.
Monitor cost forecasts, updates, and provide regular updates to District Manager to ensure adherence to budget.
Responsible for ensuring all costs and timeframes are managed to the approved budgets/forecasts and any deviations therefrom are communicated and approved as soon as discovered.
Partner across organization lines with peers in support of cross-functional Crown Castle value initiatives and to collaborate on common management goals for the district, region, and country as a whole.
Work with the Small Cell Network Operations Manager to ensure effective handoff practices and to ensure capital and repair & maintenance expenditures are coded appropriately.
Manage teams of Project Managers, Construction Managers, and Project Coordinators including hiring, terminations, performance reviews, training, rewards, and recognition, and scheduling.
Bachelor's Degree or equivalent experience in Business or related field
PMP certification preferred
Minimum of five (5) years of experience managing development projects (i.e. site acquisition, zoning, permitting and construction management)
Minimum of five (5) years of experience in project management including experience in budgeting and finance across multiple projects
Previous people management experience
Previous experience managing off-site teams strongly preferred
Thorough knowledge of telecommunications/wireless project management, asset management, and network construction in both the Public and Privates rights-of-way
Customer focus with a problem solving approach to each customer install
Disciplined approach to answering customer questions/concerns by the end of each business day
Ability to read and understand financial metrics and identify remedies to financial issues related to small cell deployments
Ability to direct a team by setting goals and priorities to facilitate achievement of organizational objectives
Strong computer skills especially Microsoft Office, Word, Excel etc.
Excellent interpersonal and verbal communication skills
Ability to read and understand blueprints
Ability to diagnose work flow problems and implement remedies
Reports to: District Manager – Small Cell Solutions
Title(s) of direct reports (if applicable): Project Manager, Construction Manager, Project Coordinator
Working Conditions: Works in normal office setting and expected to be physically present in the district office when not otherwise traveling to visit projects. Frequent travel within the district will be required, with occasional travel outside of the district.
Crown Castle is an Equal Opportunity Employer.
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Cell Processing Associate Car-T Cell Therapy Morris Plains, NJ
Cell Processing Associate CAR-T Cell Therapy
The Cell Processing Associate is responsible for intermediate processing of patient derived clinical and commercial cellular immunotherapy products. Due to the nature of the starting material (patient cells) this role requires basic proficiency and ownership of the process.
Intermediate ownership for the processing of the assigned Patient starting material in the clean room environment.
Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time.
Maintains and prepares equipment/environment for use.
Ability to work with automated cell processing equipment such as the wave bioreactor.
Ability to perform in process operations such as: bioreactor sampling, static sampling and in process environmental monitoring.
Knowledgeable in the use of production related IT systems such as SAP and MES.
Documents all steps in the assigned Batch record in line with GMP requirements.
Conduct all necessary processing steps for the assigned lot with highest skill level of aseptic technique.
Assist with deviation investigations and inspections.
Participation in assigned qualification/ validation activities, as necessary.
Responsible for successful on time completion of required training curriculum comprising of the necessary Global Operating Procedures (GOPs), Standard Operating Procedures (SOPs) and Aseptic Techniques, Gowning Qualifications and other relevant training including HSE for the specific role.
Maintains an "audit ready" module.
Perform other duties as assigned; ie. batch record review, process streamline improvements, safety walk-thrus.
Scientific Sales Representative, Cell Separation
STEMCELL Technologies Inc. is a privately-owned biotechnology international company headquartered in Vancouver that helps power leading-edge life science research around the world. Scientists performing stem cell, immunology, cancer, regenerative medicine and cellular therapy research are among those who rely on our cell culture media, cell separation products, instruments, ancillary reagents and contract assay services. We create novel, useful, standardized products of unfailing quality and deliver them to more than 70 countries via our many regional offices plus distribution centres in Vancouver, Seattle, Grenoble and Singapore. Driven by our love of science and our passion for quality, we see ourselves simply as "Scientists Helping Scientists" – standing by our customers to provide outstanding products, technical support and training. We have over 950 science-oriented employees globally, including 250 PhDs/MScs, with most others holding a BSc or engineering degree. STEMCELL is proud to be the largest Biotechnology employer in Canada and is growing significantly year after year especially in Europe, creating exciting new opportunities.
We currently have an opening for a Scientific Sales Representative, Cell Separation products based in Cologne, Germany, or home-office based. The Scientific Sales Representative's primary responsibility is to generate revenue by identifying potential customers, introducing them to our products and working with them by providing technical support and customer service so as to ensure that they purchase products and become "happy customers". The Scientific Sales Representative is responsible for ensuring that the target revenue for the territory is achieved.
DUTIES AND RESPONSIBILITIES:
Develop and propose bi-annual business plans for the territory, focusing on quarterly and annual sales objectives in accordance with overall Sales and Marketing plans
Develop and maintain business relationships with current and prospective customers within the territory
Locate new potential customers via prospecting, cold calling and setting up appointments with key decision makers
Follow up on new leads and referrals generated by Inside Sales or through marketing activities
Prepare price quotations, discounts and custom requests at the customers' request
Attend conferences, trade shows and seminars as required
Develop and maintain deep product knowledge so as to be able to sell consultatively and make recommendations to prospects and clients on solutions that best meet their research needs
Provide exceptional customer service and technical support
Liaise with Technical Support staff regarding difficult customer queries
Document all communications and customer interactions in CRM (SFDC)
Provide feedback from the field to Sales Management about market dynamics, product performance, competition and market potential
Prepare proposals to respond to requests for custom orders
BSc, MSc or PhD in Immunology, Stem Cell Biology, Hematology, Molecular Biology or an allied science, with additional years of experience to support
Excellent communication and interpersonal skills
Strong time management and organizational skills
Ability to work effectively both independently and as part of a dynamic team
German and English, business fluent
Sales experience and additional languages would be assets
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
This is an opportunity to work with highly motivated colleagues in a science-oriented, creative and dynamic environment. We offer a competitive salary, excellent benefits and significant career development opportunities.
Manager, Cell Therapy And Cell Engineering Facility (Ctcef)
At Memorial Sloan Kettering (MSK), we're not only changing the way we treat cancer, but also the way the world thinks about it. By working together and pushing forward with innovation and discovery, we're driving excellence and improving outcomes.
For the 28th year, MSK has been named a top hospital for cancer by U.S. News & World Report. We are proud to be on Becker's Healthcare list as one of the 150 Great Places to Work in Healthcare in 2018, as well as one of Glassdoor's Employees' Choice Best Place to Work for 2018. We're treating cancer, one patient at a time. Join us and make a difference every day.
The Operations and QA Manager, Cell Therapy and Cell Engineering Facility (CTCEF) directs, plans and actively participates in daily functions of the Cell Therapy and Cell Engineering Facility to ensure efficient and effective operations and compliance with all aspects of quality assurance and facility operations in a highly regulated environment. The CTCEF is responsible for the production of clinical cellular products for Phase I/II clinical trials.
Responsible for maintaining the CTCEF facility in GMP compliance
Supervises a team of 5 staff members who operate the facility, including the facility manager
Oversees gowning and personnel monitoring procedures
Oversees environmental monitoring procedures
Oversees operation and validation of equipment
Oversees qualification and quarantine of raw material
Oversees the database for the management and inventory of raw materials and clinical products.
Oversees and contributes to inspections, audits and certification of suppliers
Oversees and coordinates the multi-user GMP facility operations
Oversees facility user's qualifications (e.g training, workflow, reagents qualifications, SOPs, process validations)
Oversees the integration of multi-users raw material inventory supplies for manufacturing
Oversees production scheduling and facility turnover (e.g cleaning, room and equipment certifications)
Oversees the Equipment monitoring alarm 24/7 (> 400 units) including on-site and off-site storage of cellular clinical products
Responsible for developing and maintaining the CTCEF quality management system to ensure that the facility and processes are compliant with cGMP/FDA regulations.
Supervises one Technical writer who operates MasterControl
Develops and maintains the CTCEF quality manual
Develops and maintains the CTCEF quality management system to ensure facility and processes compliance with current 21CFR/FDA regulations and FACT/ Immune Effector Cells regulations
Oversees operation and maintenance of MasterControl: controlled documentation life cycle (e.g SOPs, MPCRs), training, deviation, change control, quality improvement, validation, audit
Oversees completion and documentation of training and on-going competency
Oversees and supports non-compliances
Prepares the facility for external audit
Oversees and conducts internal audits
Insures readiness of facility for FDA inspections
Contributes to Gene Transfer and Somatic Cell Engineering (GTF) user group production runs related documentation
Supervises a team of 2 staff members who coordinate production runs and related compliant documentation
Supports issuance of Batch Production and Controlled Records (BPCR)
Supports and coordinates the assembly, timely completion and reviewing of the BPCR
Contributes to MPCR approval
Development and implementation of new manufacturing procedures
Liaise with the Director, the Production manager and the Research and Technology Mgmt group for effective integration and FDA compliance of new procedures in the core facility.
Assists production teams with process qualifications and validations documentation
Contributes to the preparation of documents including the CMC section of INDs submitted to the FDA
Delivery of cellular products for infusion of cellular products
Helps the QA Coordinator, QC and Production staff members to coordinate tthe release and delivery of cellular products to the hospital staff in compliance with FACT/IEC regulations
Prepares budgets, chargeback invoices, facility user invoices and helps establish contract manufacturing services
Master's Degree with 5-10 years of related experience in cGMP operations, laboratory management or work in controlled therapeutic manufacturing environments is highly preferred.
Applicants must be familiar with the principles of quality assurance and FDA regulations.
excellent communication, interpersonal skills and organizational skills
- team leader, strong supervisory and leadership skills
- project management
- equipment qualification and validation
- writing reports and computer software skills #LI-SB1
MSK is an equal opportunity and affirmative action employer committed to diversity and inclusion in all aspects of recruiting and employment. All qualified individuals are encouraged to apply and will receive consideration without regard to race, color, gender, gender identity or expression, sexual orientation, national origin, age, religion, creed, disability, veteran status or any other factor which cannot lawfully be used as a basis for an employment decision.
Federal law requires employers to provide reasonable accommodation to qualified individuals with disabilities. Please tell us if you require a reasonable accommodation to apply for a job or to perform your job. Examples of reasonable accommodation include making a change to the application process or work procedures, providing documents in an alternate format, using a sign language interpreter, or using specialized equipment.
Scientist I Single Cell Transcriptomic Approaches To Cell Types In The Mouse Nervous System
The Allen Institute for Brain Science, located in Seattle, Washington, is committed to understanding how the brain works and helping to unlock the mysteries of neurological diseases and disorders affecting millions worldwide.
The Allen Institute is seeking an exceptional candidate who will be part of a Seattle-based multidisciplinary team within the Cell Types Program. The successful candidate will participate in high-throughput single cell transcriptome data generation and analysis to support the effort funded by the newly awarded BRAIN grant from the NIH, which aims to define all cell types in the adult mouse brain. The candidate will be a Ph.D. graduate in life sciences or computational biology and will possess strong experimental and computational skills. She/he will collaborate with several other departments on the identification and classification of cell types in the mouse nervous system.
Work within the Molecular Genetics team on experimental design, execution, and research associate training in order to generate large-scale single cell transcriptome datasets.
Work with Modeling, Analysis and Theory team to timely and iteratively analyze single cell data from the internal single cell transcriptomics pipeline and facilitate generation of cell type taxonomy.
Design and execute validation and follow-up experiments to place the transcriptomics results in the neurobiological context.
Write and publish manuscripts, grant progress reports and grant applications.
Present work internally and externally at conferences.
Evaluate new single cell RNA-seq platforms and techniques.
Work with Electrophysiology and Neuroanatomy teams to facilitate data organization and integration in an effort to create multimodal neuronal taxonomy.
Ph.D. in life sciences or computational biology (e.g., Neuroscience, Genomics, Genetics, or related field).
Knowledgeable in genomic data generation from primary tissues (rodent handling, dissection, single cell collection, molecular biology, and next generation sequencing).
Knowledgeable about developmental neurobiology and systems neurobiology
Knowledgeable about RNA-seq, ATAC-seq and/or ChIP-seq data
Proficiency in R and Linux shell scripting.
2+ years of experimental experience in genomic data generation from primary tissues (rodent handling, dissection, single cell collection, molecular biology, and next generation sequencing).
2+ years of experience working in a rodent model system studying a neurobiological problem in vivo (e.g., developmental neurobiology, systems neurobiology).
2+ years of computational experience working with RNA-seq, ATAC-seq and/or ChIP-seq data, preferably at the single cell level.
Ability to develop, test, implement, and share new experimental and computational tools quickly, in an iterative manner, after feedback from experimental, data production, and analysis teams.
Experience with additional programming languages (Perl, Python, Matlab) preferred.
Exceptional oral and written communication skills.
Ability to work independently as well as part of a team to meet aggressive timelines in a collaborative environment.
It is the policy of the Allen Institute to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, the Allen Institute will provide reasonable accommodations for qualified individuals with disabilities.
Director, Cell Line And Cell Culture Bioprocess Development
Five Prime Therapeutics, Inc. (NASDAQ: FPRX) is a publicly traded, clinical-stage biotechnology company focused on discovering and developing innovative immuno-oncology protein therapeutics to improve the lives of patients with serious diseases. We have an industry-leading and differentiated drug discovery platform. Our comprehensive proprietary libraries of the extracellular proteome, differentiated screening capabilities and protein therapeutic generation and engineering capabilities comprise a unique and powerful IND engine that will continue to generate important development programs. This uniquely positions us to discover novel pathways and targets in immuno-oncology. Our success with our drug discovery platform has led to a pipeline that is on track to more than double to five development programs in clinical trials across multiple indications in 2018. We also have several undisclosed research programs at different points of the target validation and molecule generation phases that have the potential to yield our next wave of development-stage therapeutic biologics. And we continue to fuel this process at the earliest stages with new screens planned this year.
Five Prime is committed to innovation and outstanding science to develop effective new drugs for the treatment of severe diseases. We value our culture of openness, collaboration and productivity. The company is in a strong financial position and has an effective executive team and Board of Directors. Discover more about FivePrime at www.fiveprime.com.
Reporting to the VP Manufacturing Sciences, this position will be responsible for providing strategic input relates to CMC decisions and will contribute significantly to the development and success of the Manufacturing Sciences team. Partner with other functional leaders from Analytical, Formulation, Supply Chain, CMO management and Quality in support of the project teams and of the organization.
This position will lead the Cell line and Cell Culture Bioprocess team for clinical and commercial manufacture of mAbs, fusion proteins and other novel biologics. The responsibilities include development of cell line and cell culture process, production of preclinical supplies at in-house bioprocess pilot plant, oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support of regulatory submissions. In addition, this individual will be accountable for overall management of the function such as resource planning, employee engagement and workflow enhancement.
Essential Functions and Duties
Key member of the Manufacturing Sciences leadership team to assess and support CMC strategy
Oversee cell line development for the selection of production cell line for master cell bank manufacturing.
Lead cell culture process development, optimization, characterization/validation, scale up and technology transfer to CMO's.
Manage process development experimental design, execution and writing process development plans/reports.
Introduce new technology to enhance workflow and capabilities.
Manage bioprocess suite, trouble-shooting of processes, instrumentation, and equipment to ensure timely in-house manufacturing to support preclinical animal studies.
Provide supervision for technology transfer and oversee CMO activities. Review, or approve batch records and SOPs; address production issues at CMO's in collaboration with quality and regulatory teams.
Acts as a mentor for the junior staff, provide coaching and emphasize best practices.
Partner with QA and Regulatory to support batch releases and regulatory submissions.
PhD in biochemistry, chemical/biochemical engineering or related disciplines
12+ years of in-depth technical experience in cell culture bioprocess development for protein drugs.
Solid knowledge and experiences in mammalian cell culture process engineering and process scale-up/scale-down design is essential.
Leadership experience with proven capability as a successful leader in a strategic multifunctional environment, highly skilled in leading change and people agility
Strong business acumen and critical thinking
Proven experience in process characterization and validation.
Hands on experiences with technology transfer of manufacturing process.
Must be scientifically knowledgeable, team-orientated, and passionate in biopharmaceutical development.
Knowledge of cGMP's, regulatory guidelines, validation practices, and other relevant regulatory requirements.
Excellent interpersonal communication and presentation skills.
At FivePrime, we believe a diverse workforce drives our success as a company. We are always working to create an environment where different backgrounds and viewpoints are valued and celebrated.
FivePrime is an equal opportunity employer. FivePrime makes employment decisions, including in recruitment and selection, without consideration of race, color, national origin, religion, sex, gender, gender identity or expression, sexual orientation, age, veteran status or disability.Please call or reply with any comments.
All your information will be kept confidential according to EEO guidelines.
Senior Mechanical Engineer – Cell Qualification And Cell R&D
This person's primary role will be ensuring current and future battery cell mechanical designs meet the requirements of Tesla's current and future battery modules, and vice versa. This person will work closely with Tesla's cell characterization and qualification team as well as battery module teams to design and execute mechanical methods that directly impact Tesla's product lifetimes and reliability. This role also involves working with module production teams to ensure cell requirements are met in actuality, not only by design. This person will work to qualify and iterate upon cell mechanical designs based on Tesla's needs and the capabilities of Tesla's cell suppliers. This person must exhibit the knowledge, leadership, and drive needed to not only challenge the status quo, but also define and execute the optimal path forward.
Design, develop, prototype, and execute mechanical test and characterization methods for battery cells and cell components
From first principles and experimental data, determine cell mechanical requirements such as maximum loads, limits of plastic deformation
Manage cell and cell-module interface requirements and work with validation teams
Be familiar with finite element methods (FEA) for mechanical modeling; work with FEA/modeling engineers to validate models and extract material parameters from mechanical tests that you have designed and performed
Produce meaningful and compelling analyses and data visualizations beyond Excel
Author technical presentations and summarize high-impact technical findings
Work in a laboratory and/or production environment, not just at a desk
Collaborate with and proactively build professional relationships with engineers, scientists, and technicians across different groups
Degree in Mechanical Engineering or similar
MS or PhD with 2+ years professional experience
BS with 4+ years professional experience
CAD; drafting; GD&T; tool / fixture / jig design
Design and execution of mechanical characterization experiments
Mechanical load frame operation, e.g. Instron, MTS, stress, strain, and creep measurements
Working with machine shops, rapid prototyping, and additive manufacturing
Building test fixtures using extruded aluminum framing and electromechanical parts e.g. pneumatic or solenoid actuators
Data acquisition systems; analog and digital signals
Extensive working knowledge of precision dimensional inspection tools
Working knowledge & relevant coursework in finite element analysis (FEA) methods
Ability to break down complex technical topics and deliver visual technical presentations (e.g. PowerPoint) to groups of engineers, scientists, and technicians
MATLAB, Python, LabVIEW, R
Mechanical testing of composite materials
Other materials test laboratory equipment
Ability to demonstrate a strong interest or passion for lithium-ion battery technology
Experience with mechanical testing of batteries
Knowledge of safety hazards of working with and mechanical testing of lithium and lithium-ion batteries
Please send most current resume and cover letter to PEControls@tesla.com
Senior Biomedical & Cell Therapy Manufacturing Development Officer
About City of Hope
City of Hope, an innovative biomedical research, treatment and educational institution with over 5,000 employees, is dedicated to the prevention and cure of cancer and other life-threatening diseases and guided by a compassionate, patient-centered philosophy.
Founded in 1913 and headquartered in Duarte, California, City of Hope is a remarkable non-profit institution, where compassion and advanced care go hand-in-hand with excellence in clinical and scientific research. City of Hope is a National Cancer Institute designated Comprehensive Cancer Center and a founding member of the National Comprehensive Cancer Network, an alliance of the nationÃ¢â¬â¢s 20 leading cancer centers that develops and institutes standards of care for cancer treatment.
SENIOR BIOMEDICAL & CELL THERAPY MANUFACTURING DEVELOPMENT OFFICER sought by Beckman Research Institute of the City of Hope in Duarte, CA.
Duties: Lead all contractual responsibilities concerning cell therapy manufacturing activities at City of Hope (COH) Center for Applied Technology Development (CATD) using knowledge of molecular biology and biologics manufacturing.
Manage and supervise all negotiations and contractual work with third parties on behalf of CATD including in-license and out-license agreements. Function as primary business development resource for CATD. Responsible for actively pursuing and facilitating collaborative sponsored research relationships and licensing relationships with outside parties.
Identify additional value and manage potential business risks for CATD and OTL. Represent CATD and OTL interests to internal stakeholders. Maintain strong working relationships with other COH departments to support COH's IP policies. Assist Director in preparation of yearly budgets and reporting of financial, patenting, and licensing activities of the office to the VP.
Master's degree or equivalent in Molecular Biology, Biological Sciences or a related field, plus four (4) years of experience as Biomedical and Cell Therapy Manufacturing Development Officer, Technology Licensing Manager/Specialist or related occupation, including experience in licensing negotiation, academic contracting, and intellectual property protection; experience in cGMP contract negotiation including biologics manufacturing processes including lentivirus manufacturing and stem cells manufacturing, clinical research, human subject research, and non-profit academic issues; managing technologies in diabetes and oncology including blood cancers and solid cancers; managing technologies in immune-oncology including antibody technology, cancer vaccines, and chimeric antigen receptor T cell therapy; leading in over five (5) patent exclusive license deals in diabetes or oncology; and working on license deal structure and comparables for early stage technologies.
City of Hope is committed to creating a diverse environment and is proud to be an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, religion, color, national origin, sex, sexual orientation, gender identity, age, status as a protected veteran, or status as a qualified individual with disability.
Sourcing And Contract Analyst – Cell And Gene
Welcome to the future of medicine.
Be part of a rapidly growing, diverse and high calibre team of passionate people who strive to make a difference. Join the Novartis team in Prague and enjoy our inspiring environment. We offer a comprehensive compensation package, a wealth of opportunities for career development and an undeniably friendly culture.
Novartis is currently searching for a Lead S2C Analyst to join the Procurement team in Prague.
The Sourcing and Contract Analyst – Cell and Gene provides cross functional support to strategic Cell and Gene procurement managers and Cell and Gene development project teams over Globe. The Lead S2C Analyst acts as an extended team member assuring the delivery of quality, timely and cost-effective materials and services and relevant contracts to support the Cell and Gene development processes.
This role includes a set of Cell and Gene procurement activities allocated to GSC following either a process specific pre-defined GSC outsourcing logic or a case-by-case gating/triage methodology. Procurement activities at GSC Cell and Gene procurement include:
- Support supplier evaluations by running RFI, RFP and RFQ processes in collaboration with Cell and Gene line function and/or the strategic procurement managers, this might include e-sourcing and e-auction processes. Discuss and prepare content and structure of those evaluations according to the characteristics and needs of the business case in an independent manner.
Consolidate and document the outcome for decision making by the line function and/or Cell and Gene strategic procurement.
Assist to price analysis, vendor risk assessments and due diligence activities
Contribute to vendor audit requests and facilitate corrective action plans
Support new vendor onboarding and relevant system set-up activities in SIM, contribute to vendor audit requests and facilitate corrective action plans.
Produce final contracts understanding content and business drivers with particular focus on protecting IP and freedom to operate. This includes Confidentiality Agreements CDAs, Master Supply/Service Agreements (frame agreements), Work-orders and amendments.
Manage traffic of contractual documents to ensure timely and compliant execution.
Archiving legally relevant communication and documents
Negotiations of smaller business cases and contract terms below defined value threshold. Ensure agreements are commercial advantageous to Novartis while minimizing risk through close collaboration with functional partners such as legal, finance, and QA.
Report resulting savings.
Consolidation of supplier-, market-, category- and internal business data
Supplier performance measurement processes collecting and assessing KPI's and consolidating them in supplier performance dashboards
Assisting in monitoring compliance and adherence to Novartis Procurement policies and procedures
Supporting the buying process executed at line-function level by acting as a gating and/or coordinating role
Resolve Req-to-Pay issues
Participate in initiatives to drive functional objectives
Novartis Global Service Center (NGSC) in Prague:
The Center, one of 5 around the world, delivers a broad variety of services to the Novartis worldwide. We have highly qualified teams in areas such as scientific and commercial services (known as Product Lifecycle Services), IT, Human Resources, Financial Reporting & Accounting, Procurement, Real Estate and Facility Services, Legal & Compliance, Finance and Communications.
Here's some of the reasons we think you should join us:
A job with a purpose. At Novartis, we all contribute to our mission to discover new ways to improve and extend people's lives.
A wealth of opportunities for career progression and working with best-in-class professionals.
A diverse team that reflects the rich diversity of our markets. Over 55 nationalities speaking with 30+ languages, all generations, and more than 44% of female.
Our modern and newly designed workplace is a pleasant place that reflects the need for flexible ways of working in order to bring new ideas to life.
We live by our values; we cherish not only what we do but also how we do it. .
Diversity & Inclusion mind-set. We aspire to move beyond stereotypes and bias to bring differences together, so we can see the world through the eyes of our patients and customers.
Our comprehensive compensation package includes:
Annual performance-based bonus;
Employee recognition scheme;
A benefits scheme above local legislation standards including pension and risk-life insurance, benefit package for health, education, culture and sport activities;
Healthcare program that offers easy access to comprehensive health care;
Variety of medical check-ups or consultations on-site;
An Employee Assistance Program;
25 days annual leave, 4 days paid sick leave and Christmas holiday;
Public transport allowance;
Flexible working arrangements including Home Office;
Support for a healthy lifestyle through the daily offering of fruit & vegetables.
We are looking forward to talking to you and sharing more about our broad range of opportunities.
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