Cell Preparer Job Description Sample
Location : Arlington, VA 22209
Duration : 5 Months
please send across your updated resume to firstname.lastname@example.org
Bachelor's Degree in relevant business or technical field, JD Preferred.
1 year work experience required. Ability to review documents in Relativity database and fill in information in Relativity.
Experience with Relativity or other review database would be a plus
Read lease documentation and abstract lease information in Relativity. Answers to Abstraction Reviewer comments on leases abstracted. Escalates issues and questions identified in leases abstracted.
Lab Technician - Mammalian Cell Culture (Cell Line Production)
Are you interested in being a part of a growing product line? ATUM (formerly DNA2.0) is in need of a Lab Technician experienced in mammalian cell culture to work in our cell line lab. You’ll be a key part of the cell line team and have the opportunity to work with multiple departments in a fun and collaborative work environment.
ATUM is the leading bioengineering solutions provider, offering an integrated pipeline of solutions including gene design, optimization and synthesis, expression vectors, and platforms for protein and strain engineering as well as cell line development and master cell banking. From building the industry’s leading antibody libraries to developing enzymes for commercial drug and biofuel manufacture, our products and services support breakthroughs across the life sciences. Every day ATUM delivers DNA, proteins and cells that transform biology from a discovery science to an engineering discipline, improving the way people research, create and live. For more information about us visit www.atum.bio.
Responsibilities of the position:
- Tissue Culture
- Maintain and transfect various BL1 safety level, non hazardous mammalian cell lines using sterile techniques; establish stable cell lines for the generation of recombinant proteins or for cell line engineering approaches. Determine cell counts and cell viability using microscope and various automated cell counting devices.
- Monitor metabolites and macromolecular products and take end point measurements that could include Western blotting, productivity measurement using ForteBio Octet, immunostaining or molecular characterization (PCR, blotting techniques). Use automated cloning and imaging equipment. Prepare cells for cryogenic storage and subsequent re-establishment of viable cell lines.
- Record Keeping in LIMS and Maintenance of Lab: Maintain clean and neat work area in laboratory to ensure efficient functioning and pleasant/safe work environment. Prepare sterile media and solutions.
- Maintenance of lab supplies and equipment: Monitor, order, and shelve tissue culture supplies. Work with other members of the lab and purchasing department to ensure sufficient supply levels for scheduled projects. Work with facilities to coordinate laboratory machinery ordering, installation and regular maintenance.
- Follow written instructions/operation manuals while demonstrating strong verbal communication skills.
- Other duties as assigned.
- Occasional weekend and holiday work may be required.
- Bachelor’s degree and cell biology background required.
- Work Experience: minimum of 1 year of tissue culture laboratory experience.
- Knowledge and experience of tissue culture technique and good sterile technique.
- Flexible and adaptive behavior and ability to thrive in a high growth environment.
- Experience with mammalian cell bank manufacturing and/or working under cGMP conditions are a plus.
This position requires the ability to repetitively move and/or pour a minimum of 5lbs (up to 25lbs may occasionally be required) as well as other physical activities, including:
- Regularly opening and closing lab receptacles, including removing and adhering plate seals, twisting caps, lifting lids.
- Occasionally ascending/descending a ladder to retrieve lab supplies.
- Regularly positioning self to pour or pipette reagents used for the lab process, including large and small volumes.
- Regularly perform long processes (multiple hours) in front of biological safety cabinets.
- Regularly lifting and re-positioning racks (approximately 10lbs each) stored in liquid tanks.
- Regularly work for extended periods (3-4 hours) wearing 2 layers of breathable disposable standard gowning garments.
- Be part of the next gen bio-tech revolution: Quantitative Biology
- Learn new concepts and experiment with new technologies
- Free catered lunch (everyday)
- Excellent benefit package; medical, dental and vision, PTO, Holidays, and more.
- 401(k) & Safe Harbor plan
We encourage qualified veterans to apply.
Phone calls NOT accepted.
Small Cell Project Manager
- Orchestrating a virtual team of consultants, project managers, construction managers, engineers, and service delivery coordinators
- Lead all elements of turn-key deployment
- Closely manage internal staff and external consultants through the site acquisition process to successful lease signatures for each node
- Coordinate with OSP project managers to ensure fiber design and construction meets project budget and schedule
- Coordinate with internal resources and external consultants to ensure compliance with FCC and environmental regulations
- Coordinate with ISP construction manager for successful zoning, permitting, and construction of small cell and antenna installation and testing
- Validate and manage customer requirements and expectations
- Upon project kickoff, ensure and maintain alignment with the customer regarding schedule, technical requirements, build responsibilities, and handoffs
- Develop and manage the project schedule and budget
- Maintain and report on the project schedules and budgets over the life of the project through full project closeout
- Manage against the schedule and budget baselines to drive progress, identify and mitigate risks, and achieve measurable results
- Ensure all team members are in alignment with goals, are accountable for their results, and are effectively contributing to the team’s success
- Identify, track, follow-up, and resolve all issues and actions encountered
- Develop and implement project processes, reporting, and metrics that record progress, ensure quality, reinforce ownership and accountability, demonstrate trends, identify bottlenecks, and achieve results
- Adapt current reporting to the specific needs of the project or develop new reporting if required
- Demonstrated successful overall project management responsibility of large-scale network deployments, ideally related to OSP and/or wireless networks
- Proven ability to develop project schedules and budgets, maintain forecasts and report variances
- Process- and metrics-based management style
- Exceptional report development, implementation and analysis skills
- Ability to adapt existing reporting or develop new to match the unique and changing needs of each project while working within Our Client reporting standards
- Must be strong in Excel (formulas, macros, pivots), Access or similar
- Working knowledge of Salesforce is a plus
- Proven ability to manage a virtual team across various functional and geographic regions so as to drive engagement, maintain goal alignment, achieve results and make the project a rewarding experience for the team
- Must be able to provide direction to multiple functions to ensure project timelines and contractual commitments are met
- Experience with ISP construction (space/power/building riser) a plus
- Ability to act as a key customer point of contact. Includes preparing and leading customers through regular status updates, managing expectations and addressing customer-facing issues. Scope management extremely important to ensure projects' financial success
- Contract/construction management experience including RFP preparation, budgeting and control estimates, bid review and award, change order management, materials management and project closeout
- Basic understanding of OSP construction management is a plus
- Working knowledge of GIS-based tools such as MapInfo, ArcView or Google Earth or Third party conduit and fiber negotiation and purchase
- Familiarity with wireless deployments a plus including site acquisition and leasing, basic cell site layout and wireless site civil construction
Clients turn to Atrilogy for expertise in:
- IT staffing and placement (Project Managers, Agile/Scrum Masters, Business Analysts, DBA’s, Software Engineers, Mobile Developers (iOS, Android), DevOps, Automation, QA, Systems & Network Engineers, Cyber Security / Information Security Specialists)
- All major ERP & CRM packages (including Oracle, Workday, PeopleSoft, JD Edwards, Lawson, SAP, Dynamics AX, Salesforce, Microsoft CRM, NetSuite)
- Business Intelligence, Data Warehousing, and Big Data Integration
- Creative (Interactive Project Manager/Art Director, Information Architect, UI/UX Designer, Web/Graphic Design)
Atrilogy Solutions Group is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, gender expression, national origin, protected veteran status, or any other basis protected by applicable law, and will not be discriminated against on the basis of disability.
In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Research Associate II - Cell Editing
Universal Cells is now part of Astellas!
Developing innovative therapies is one of the most challenging, most essential and personally rewarding fields in science. This is the most exciting time to be a part of Astellas, a company with a uniquely collaborative and patient-focused culture.
There's something special about working at Astellas. It's reflected in our focus on the people we serve, the way we treat each other and the results we achieve together as a company.
Astellas is announcing a Research Associate II -- Cell Editing opportunity at their Universal Cells facility in Seattle, WA.
Universal Cells carries out AAV-mediated gene-editing of pluripotent stem cells using a non-GMP Qualified Manufacturing Process (QMP). The Cell Editing RA 2 will work as part of a team evaluating, planning, and executing all aspects of gene-editing and engineering of pluripotent stem cells.
Will acquire further versatility in routine procedures, technical knowledge, understanding of administrative operations, and general troubleshooting. Will assist with complex laboratory operations, and take on more responsibility to provide content for various documents and reports. Will be able to execute protocols with minimal guidance, and the ability to summarize results independently.
Essential Job Responsibilities:
Cell culture and aseptic processing in a GMP-like manufacturing environment.
AAV-mediated gene-editing of pluripotent stem cells.
Data collection and analysis for cell culture and gene-editing processes.
Design and execution of complex experiments.
Support Process Development to establish and transfer manufacturing processes.
Lead group meeting preparations and presentations.
Ensure day-to-day operations of the QMP cell culture lab.
Maintains familiarity with scientific literature and applies appropriately to research projects.
- BS degree with 3+ years
- MS with 0-2 years of laboratory experience
Strong organizational, time management and problem solving skills with attention to details.
Ability to work independently yet also a team player.
Excellent record-keeping ability.
The statements above are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not to be construed as an exhaustive list of all responsibilities, duties, and skills required of personnel so classified. All personnel may be required to perform duties outside of their normal responsibilities from time to time.
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
Tax Preparer (January-April 2019)
Baker Tilly Virchow Krause, LLP (Baker Tilly) is a nationally recognized, full-service accounting and advisory firm whose specialized professionals connect with clients and their businesses through refreshing candor and clear industry insight. With approximately 2,700 employees across the United States, Baker Tilly is ranked as one of the 15 largest accounting and advisory firms in the country. Headquartered in Chicago, Baker Tilly is an independent member of Baker Tilly International, a worldwide network of independent accounting and business advisory firms in 147 territories, with over 33,000 professionals. The combined worldwide revenue of independent member firms is $3.4 billion.
It's an exciting time to join Baker Tilly! We are seeking several Seasonal Tax Preparers to join our team this tax season in Madison, WI!
While prior tax preparation experience is ideal, experience is not necessary. Provided you meet the job qualifications, we'll teach you what you need to know in order to help successfully prepare client tax returns. And, your training will be 100% paid! Baker Tilly offers a professional, yet relaxed and fun, work environment. You'll feel at home quickly and will be supported by tax professionals who are available to help when you have a question. Flexible work hours may be an option, and you'll have the opportunity to return each tax season!
Baker Tilly Annual Report 2017
Enter client data into tax prep software
Prepare tax returns in accordance with firm policies
Adhere to the firm's written tax practice standards and the firm's 1040 procedure manual
Ensure client confidentiality by following all company procedures regarding information handling
High school diploma required; Associate's or Bachelor's degree preferred
Individual tax return preparation ideal, but not required
Knowledge of basic accounting concepts involved in tax return preparation ideal, but not required
Experience with Adobe Acrobat is preferred
Adaptable to new technology and ability to work in a paperless environment
A professional demeanor and the ability to handle matters confidentially
Keen sense of accuracy and attention to detail
Demonstrated critical thinking, well-developed problem solving skills, and ability to work independently
Solid written and verbal communication skills
Ability to provide exceptional client service and exhibit a sense of urgency to complete work in a timely manner
Availability to work February 2019 through mid-April 2019
Cell Therapy Process Validation Scientist - Innovative Gene Therapies
Reporting To: Senior Scientist, Cell Therapy Operations
Location: Menlo Park, Ca
Orchard Therapeutics, Ltd. is a biotechnology company incorporated in September 2015 and dedicated to bringing transformative gene therapies to patients with serious and life-threatening rare diseases. This an exciting opportunity for a well-qualified candidate to join a rapidly growing international company focused on transforming the lives of patients through innovative gene therapies.
The Cell Therapy Process Validation Scientist will lead activities for development, scale up, optimization, and validation of Orchard Therapeutics’ innovative gene-modified cell-based therapeutic products. Such activities will include process and assay development, cell therapy intermediate and final drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls to support company’s product programs from pre-clinical research through to commercial.
- Lead development, scale-up, optimization, and validation of cell isolation, cell culture, cell transduction and cell cryopreservation processes to include:
- Process and assay development, cell therapy intermediate and final drug product formulation and stability evaluation, raw material evaluation, process scale-up / scale-out, and validation of manufacturing processes and controls
- Compile, review and edit master production records, standard operating procedures, development/validation protocols and reports
- Perform FMEA risk assessments for cell therapy manufacturing processes
- Provide SME review of executed batch, records, test records and associated documentation for release of gene-modified cell therapy products. Support investigations.
- Co-ordinate activities with the research, pre-clinical development, QA, QC, clinical development and commercial departments to ensure the successful achievement of company timelines and milestones
- Prepare protocols and reports for prospective qualification and validation activities
- Ensure the successful execution of activities performed between departments and company designated collaborators and CMO’s
- Prepare CMC / CTD documents for regulatory filings with US and EU regulatory agencies
- Other activities as may be assigned
The ideal candidate for this position must have experience in the development, manufacture and delivery of cell-based therapy products with significant applied experience in the biotechnology industry. Candidate must possess:
- Experience designing and executing process validation experiments using statistical multi-parameter design methods such as DOE
- Experience performing FMEA risk assessments
- Experience managing process and assay development and validation in support of GMP operations
- Experience preparing documentation for regulatory filings with US and EU regulatory agencies
- Experience with the set-up and technology transfer of manufacturing processes and controls at international CMOs
- In-depth knowledge of FDA, EMA, GMP and ICH regulatory requirements
EDUCATION & SKILL REQUIREMENTS:
- PhD in Biomedical Engineering or equivalent with at least 5 years of postdoctoral industry experience in bio-processing, medical technology, or biological sciences with a primary focus on the development, manufacture, distribution and delivery of cell-based therapy products. Experience in lieu of advanced degree will be considered
- Proven personnel and project management skills
- Outstanding organizational skills
- Excellent written and oral communication skills
- Ability to operate in a fast-paced, multi-disciplinary industrial environment
- Experience of GMP cell processing production equipment operation and validation, including IQ, OQ & PQ a plus
The successful candidate will enjoy a competitive base salary and the opportunity to participate in incentive compensation programs, including a stock option plans. Orchard Therapeutics, Ltd. offers a comprehensive benefits program, including: medical, dental and vision care; paid vacation and holiday time; access to a voluntary 401(k). Orchard Therapeutics is an equal opportunity employer.
Notice to All Applicants: Orchard Therapeutics participates in E-Verify
Notice to RECRUITERS: All employment offers and CV’s are managed through our Human Resources Department and all candidates are presented through this avenue. Therefore, the Human Resources Department at Orchard Therapeutics requests that recruiters are not to contact Orchard Therapeutics employees directly to present candidates. Complying with this request will be a factor in determining future professional relationships with Orchard Therapeutics. Orchard Therapeutics will not accept unsolicited resumes from any source other than directly from candidates for either current or future positions. Submission of unsolicited resumes in advance of an agreement between the Human Resources Department and the recruiter does not create any implied obligation on the part of Orchard Therapeutics.
Research Associate, Cell And Molecular Biology
Founded in 2016, Foghorn Therapeutics discovers and develops novel drugs to treat cancer and other serious medical disorders. The company seeks to discover novel therapeutics that target chromatin remodeling complexes. Foghorn uses a proprietary platform based on revolutionary advances in mechanistic understanding of disease.
- B.S./M.S. with 1-3 years of relevant experience in oncology drug discovery, including cell assay development and target validation.
- Proven core competence in standard cell and molecular biology techniques.
- Excellent lab practice and versatility is highly required.
- Ability to think critically and creatively to solve problems.
- Commitment to quality, attention to detail, and team player mentality is a must.
- Work as part of an interdisciplinary team contributing to the design and execution of experiments that support our research activities and project goals.
- Design, conduct, and analyze data from experiment for target ID and validation.
- Establish and perform cellular assays to support drug discovery programs.
- Contribute to various aspects of company building, from scientific excellence to establishing a great company culture.
Cell Processing Lead
The Novartis Cell & Gene Technical Development and Manufacturing team is seeking a Cell Processing Lead in Morris Plains, NJ.
Novartis provides innovative healthcare solutions that address the evolving needs of patients and societies. Headquartered in Basel, Switzerland, Novartis offers a diversified portfolio to best meet these needs: innovative medicines, cost-saving generic and biosimilar pharmaceuticals and eye care. Novartis has leading positions globally in each of these areas. In 2017, the Group achieved net sales of USD 49.1 billion, while R&D throughout the Group amounted to approximately USD 9.0 billion. Novartis Group companies employ approximately 122,000 full-time-equivalent associates. Novartis products are sold in approximately 155 countries around the world. For more information, please visit http://www.novartis.com.
The Cell Processing Lead is to serve as the single point of contact and module coordinator for the Cell Processing Work Cell. In addition to cell processing activities, the lead will ensure safety, quality, and smooth day-to-day operations within the module work cell.
The Cell Processing Lead is seen as an SME who is capable of working independently with little to no oversight with regards to day to day activities and assignments and is able to perform training and/or mentoring on all relevant production activities for others.
Within the organization:Facilitate the Tier 1 meeting. Making schedule and personal adjustments as necessary to properly staff module.
Trains coaches, and mentors Cell Processing Associates and Cell Processing Specialists I and II on all relevant production activities.
Communicate module shift report to manager.
Super user in MES, LIMS and SAP.
Work closely with the Manager to ensure all associates are performing disinfection task according to procedures/SOP's and regulatory standards
Possesses basic technical knowledge and background
Assists with the execution of validation activities
Improves the efficiency and execution of SOPs
Assist the Manager with internal pre-audits walkthroughs, CGMP housekeeping and general organization and upkeep of manufacturing spaces
Assists the Manager with communication on job related information during daily Tier meetings
Prepares and adjusts work assignment schedule for team
Trains others on SOPs, equipment, all unit operations and non-manufacturing SOPs and systems
Ability to gown aseptically and work in a clean room environment (ISO 8, 7 and ISO 5) areas for extended periods of time
Day 0, cell washing and Harvest processing with the ability to work with automated equipment such as the CS5 and Sepax,
NC-200 and in process environmental monitoring
Maintains and prepares equipment/environment for use
Proficient in the use of production related IT systems such as SAP, LIMS and MES
Documents all steps in the assigned Batch record in line with GMP requirements
Conduct all necessary processing/verification steps for the assigned lot with highest skill level of aseptic technique
Assist on Deviation Investigations and Inspections
Participation in assigned qualification/ validation activities
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
Understand and adhere to all SOPs, cGMPs, and safety rules and regulations.
Assist with any PU project initiatives.
Provides innovative solutions to resolve complex issues.
Represents PU in cross functional teams, projects and GXP related problem resolution.
Participates in the development of technical documents such as non-conforming events and deviations
Key Performance Indicators
Right First Time Batch Record execution
95% training compliance of all associates
Adherence to attendance guidelines and all safety related procedures
Manufacturing compliance/adherent to all GDP/GMP principles
Aseptic/Cleanroom behavior in accordance with GMP guidelines
Is seen as a trustworthy resource that fully understands the production process.
Normally receives no instructions on routine work.
Exemplify and demonstrate highest quality and safety standards.
Demonstrates discipline and self-motivation.
Decision making and problem solving skills.
Time management and ability to multi-task.
Sr. Systems Analyst - Cell Therapy Development
The successful candidate will define, develop, deliver and support laboratory automation, data management and data analytics solutions for Cell Therapy Development in Juno Therapeutics and Celgene. He/She will follow pre-defined development tools and procedures in design, implementation, deployment and production support of scientific software used by Cell Therapy Development teams, including both commercial software products as well as in-house developed systems. The incumbent will provide support to end users on day-to-day operations, prepare user trainings and documentation.
Drive collaboration among the Juno and Celgene Process and Analytical groups, Technology and Innovation teams at Juno Seattle and Munich as well as QC and Tech Transfer departments, developing business justification for new capabilities, capturing and analyzing business requirements, providing input on design and implementation strategy.
Coordinate with internal departments and external vendors to implement new release updates, develop and deploy new or enhanced protocols and templates. Actively take the ownership of key deliverables such as User Requirements Specifications, Function Specification, Design Specifications and test scripts.
Provide end user support on system administration, system configuration, and data templates customizations
Collaborate with project manager, solution architect, infrastructure team, and vendor as needed to support successful delivery of technical solutions
Work with cross-functional teams to resolve technical issues
Bachelor's or advanced degree in Computer Science or a similar degree in a scientific discipline (pharmaceutical process, or chemical engineering) with computer science experience
Proven expertise implementing and supporting scientific applications such as laboratory information system (LIMS), laboratory environment monitoring and instrument scheduling
Experience in relational database programming in e.g. SQL server/Oracle/MySql/ Postgresql databases ( stored procedures and ad hoc SQL queries)
Ability to write integration code for multiple internal/external databases and instruments
Working knowledge of Linux, AWS, JIRA, IDEs
Experience with scientific intelligence tools, eg. Spotfire or Tableau
Strong verbal communication skills and interpersonal skills are required
Expert analytical and troubleshooting skills
Must be able to work independently and effectively with cross functional teams
Ability to multitask in a fast-paced research environment
5+ year of relevant working experience is required
Basic understanding of the pharmaceutical development process and bioassay data structures is a plus
Previous R&D IT experience in Biotech/Pharma environment is a plus
Our headquarters, situated in the bustling South Lake Union district of Seattle, sits among some of the most visible organizations in the world. Seattle offers award-winning restaurants, a vibrant, hip music scene and spectacular views of water and mountains. Within an hour's drive of Seattle, you can be fishing, skiing, hiking or tasting world-class Washington wines.
THINK BIG. BE BRAVE. DELIVER.
Analytical Development Scientist, Cell Therapy
Bayer and CRISPR Therapeutics have entered into an agreement to create a Joint Venture (Casebia Therapeutics) to discover, develop and commercialize new breakthrough therapeutics to cure blood disorders, eye diseases / blindness, and heart disease. CRISPR Therapeutics will contribute its proprietary CRISPR-Cas9 gene-editing technology and intellectual property, while Bayer will make available its protein engineering expertise and relevant disease know-how. It is the first long-term strategic partnership of its kind to make a substantial investment in the development of target delivery systems to bring systemic in vivo CRISPR-Cas9 gene editing technology applications to patients.
For more information, please visit www.casebia.com
Casebia Therapeutics is seeking an Analytical Development Scientist with a passion for delivering life-changing breakthrough therapeutics to patients. She/he will lead the development of analytics for cellular therapy products based on Casebia’s gene-editing technology. The ideal candidate will have a strong background in immunology and hands-on technical experience with development and qualification of GMP-compliant analytical methods for cell-based therapies. This position includes both lab and management responsibilities and you will work closely with the Research and Discovery teams located both in Cambridge, MA and San Francisco, CA. You will participate in development of strategy to release and characterize the T-cell drug product and execute on the strategy through development of fit for purpose methods at Casebia and at contract organizations and eventual establishment in a GMP manufacturing facility for in-process testing and product release.
- Manage analytical development projects hands-on for gene-edited ex vivo T-cell therapy products for structural and functional characterization of products to be used in the clinic.
- Design and execute method development and qualification in support of process development, product release and stability, product characterization and investigation, for gene-edited T-cells
- Summarize and present scientific data and report progress on behalf of the team in cross-functional forums (e.g. CMC team) and liaison with the research teams
- Lead definition of the quality target product profile working with stakeholders in discovery, pre-clinical, and translational functions and use to develop critical quality attributes for product
- Contribute to development of assays on the drug product that can predict safety and efficacy outcomes considering input material variability etc.
- Contribute to CMC teams and communicate and collaborate effectively to ensure effective interactions with all stakeholder groups
- Ensure high-quality, timely documentation in electronic laboratory notebooks and Technical Reports
- Contribute to transfer of the analytical methods to a CMO and manage implementation and qualification activities leading to successful use of methods in QC to release and characterize GMP T-cell product.
- Assist in the development of standard operating procedures, analytical test methods, analytical sampling plans involving immunoassays, and molecular biology techniques
- Author and/or review process documentation including study protocols, reports, SOPs, batch records, material and product specifications, forms and deviation support documents
- Contribute to regulatory interactions and filings and responses to regulatory questions
- Support and contribute to relevant and impactful innovation programs to enhance T-cell analytical technologies in the areas of cell phenotyping, potency measurement, sorting technologies to characterize sub-populations, single cell approaches, aligned with emerging business drivers and regulatory expectations
- Hires, trains, supervises and mentors junior staff members
- MS or PhD in a relevant scientific discipline (e.g. Immunology, Molecular Biology, Cell Biology, Biology) with 5 – 8 years relevant experience (5+ years for Ph.D. OR 8+ years for M.S.) including experience in industry
- Experience in developing and executing cellular characterization assays with cell therapy products, including T cells, is a plus
- Previous experience managing/mentoring associate scientists in a laboratory setting is a preferred.
- Experience working with viral vectors for gene delivery and/or various gene editing techniques
- Experience authoring sections of regulatory documents preferred.
- Experience with assay transfer and managing work with external partners and contract organizations in a GMP compliant setting
- Analytical method development and qualification experience in molecular biology and cell biology techniques for cell characterization such as quantitative PCR (qPCR), immunoassay, and flow cytometry
- Strong foundational knowledge in immunology and hands-on experience with T-cells or similar cell types
- Demonstrate a strong skill set and knowledge in analytical assay development and assay optimization. Understanding and experience of analytical assay validation is a plus
- Demonstrated knowledge of pharmaceutical manufacturing of biotechnology products, analytical method development, technology transfer, method qualification/validation, and process development
- Awareness of GMP manufacturing environment for cell therapy products, including closed-systems, single-use / disposable technology, sterile / aseptic processing, and process qualification
- Awareness of GMP and CMC regulations for gene and cell therapy, including Advanced Therapy Medicinal Product (ATMP) regulations
- Demonstrated scientific aptitude through authorship of peer-reviewed publications
- Ability to manage priorities, influence without authority, and drive to decisions in a fast-paced environment to achieve deliverables in a timely fashion
- Strong interpersonal skills including verbal and written communication skills are essential in this collaborative work environment
- Ability to collaborate effectively in a team-oriented environment; driven and highly organized
- Willingness to travel approximately 20% of the time to engage with R&D teams and external CMOs.
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