RESPONSIBILITES/DUTIES

THE CLINICAL RESEARCH COORDINATOR IS A MID-LEVEL, EXEMPT POSITION AT CELLPHIRE.

Clinical Program

• Assist Clinical Director and Quality Manager in short/long-term planning
• Participate as the Clinical Research representative on internal product development teams
• Interface with CRO, medical monitor, regulatory consultant and sites on a regular basis to ensure effective and seamless trial execution
• Facilitate and oversee team, CRO, and investigator meetings
• Coordinate meetings and participate in internal and external meetings with CROs and consultants
• Develop scientific presentations that demonstrate an in-depth knowledge of the investigational drug, AE profile, therapeutic indication and protocol
• Assist in review of clinical research budget and clinical trial agreements
• Leadership and coordination for cross-functional internal project team, including scope management, risk identification and mitigation, timeline tracking and reporting, quality and cost of deliverables.
• Facilitate development and reviews of study related documents, including protocols, informed consent forms, case report forms, investigational brochure, clinical study reports, developmental plans, clinical trial plans developed by CRO, and departmental SOPs

Trial Management

• Responsible for creation, maintenance and archiving of sponsor-required clinical trial documents (TMF) and/or oversight of the CRO management of the TMF
• Review all Clinical Trial Plans developed by the CRO
• Partner with CRO to develop processes to facilitate recruitment, and enrollment for clinical studies
• Track status of manufacturing schedule for clinical studies
• Present and communicate study progress to clinical management on a consistent basis
• Maintain and effective risk plan with Cellphire and/or CRO, internal team and other stakeholders/vendors, as appropriate
• Oversee consistency between sites' SOPs and study requirements
• Review monitoring reports on an ongoing basis as study sponsor
• Assist in responding to audits conducted by Clinical Quality Assurance at selected study sites
• Assist in the identification, assessment and management oversight of contracts, CROs, vendors, and program -related consultants
• Train site personnel on sponsor/CRO and regulatory requirements for study conduct as required
• Assist in developing training materials and SOPs
• Assist the Cellphire Medical Monitor when needed in the investigation or review of corrective actions and follow-up medical care for study subjects
• Ensure clinical trial registry requirements are met
• Ensure proper collection, processing and shipment of specimens and clinical product
• Develop and update instructions for use of investigational product at clinical site with CRO
• Coordinate with manufacturing or CMO as appropriate to ensure adequate investigational drug supplies and batch acceptance maintained at the site based upon enrollment demands
• Ensure clinical batch compliance with protocol requirements
• Coordinate with CRO to ensure appropriate maintenance of accountability and reconciliation of investigational product
  Interface with CRO to provide any requested information on product to DMC/Medical Monitor

Regulatory

• Communicate with FDA project manager about regulatory related amendments and/or meetings in preparation for next clinical studies
• Review IND documents for publishing in electronic Common Technical Document format (eCTD)
• Conduct ongoing review of regulatory document files in support of field CRO staff and site
• Coordinate with CRO publishing company in all aspects for formatting, editing, and publishing
• Coordinate, submit, and assist in design and development of interim documents to regulatory agency
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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Bachelor's or Master's degree, preferably in scientific or public health discipline 

Experience:  

• 5-10 years total
• 2-5 years performing duties of a CTA (clinical trial associate), CRC (clinical research coordinator) [as defined by Association of Clinical Research Professionals] or as a CRP (clinical research professional) [as defined by Society of Clinical Research Associates]
• Professional certification (e.g., ACRP, SOCRA) a plus
• Experience/qualifications in a medical profession or new product development

Additional Skills:

• Must be well experienced with Microsoft Project, and Microsoft Office Suite Products including MS Word, Excel, and PowerPoint.  SharePoint and Visio experience is desirable but not required.  Basic understanding of FDA regulations and the biologics development process desired and electronic submission requirements (eCTD).  Familiarity with FAR also is a plus.
• A successful candidate will possess strong leadership qualities, analytical and problem-solving skills, effective writing and verbal communication skills, a demonstrated ability to work well with others and to multi-task when required.
• The candidate must be willing to work in a fast-paced biotechnology environment and to work a flexible schedule on short notice.  Late-night and weekend work will be required occasionally but not routinely.  Limited travel may be required.
• Cellphire is an equal opportunity employer and provides a comprehensive benefits package.  Salary will be commensurate with experience.

Physical Demands:

• Travel:  As required

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RESPONSIBILITES/DUTIES

Provides technical and administrative managerial leadership to the manufacturing operations, process scale up, and process validation activities. The Manufacturing Director coordinates with the EVP all plans and schedules and is responsible for all technical issues including the freeze dryers. Additionally, they manage coordination of raw material delivery from the supplier to either Cellphire or a Contract Manufacturing Organization (CMO) and delivery of samples or vials from appropriate raw material or finished product testing facilities as needed. The Manufacturing Director supports corporate projects ensuring compliance with SOPs and cGMP practices. The Manufacturing Director must possess both the technical skills necessary to develop optimal process parameters for candidate materials as well as managerial experience and skills to direct the affairs of a program. Ensures plans and resources (people, facilities, supplies, etc.) are efficiently utilized to ensure completion of manufacturing at Cellphire and/or by a CMO to meet established production timelines and acceptance criteria. Develops comprehensive operating plans and budgets and monitors achievement of business and financial goals. Ensures the development of effective working relationships with internal; staff and external partners.

The Manufacturing Director will supervise the manufacturing team and process development team supporting both routine and R&D efforts. He/she will involve in the CMO selection and supervision. He/she will report directly to the Executive Vice President.

‍General

• Reports directly to the Chief Operating Officer and Executive Vice President
• Makes recommendations and then manages agreed upon budgets, manpower and other resources within contractual restraints and corporate policy
• Makes staffing requirements recommendations for all projects requiring manufacturing
• Makes recommendations for any changes to any production methods
• Conducts briefings and technical meetings for senior management and for customer representatives
• Maintains the quality of the technical output and the performance of the programs
• Develops and implements new and unique methods and procedures for highly complex technical problems

Product and Manufacturing

• Leads, plans, manages, and coordinates activities to provide Manufacturing and Process Scale up management at Cellphire
• Provides input to the Project Manager and prepares a project plan including all steps and associated timing, resources, materials, and facility/equipment requirements and milestones
• Coordinates monitoring of milestones with customer and the Project Manager
• Prepares protocols, procedures, and specifications as required, which are in compliance with applicable Cellphire Policies and Quality System SOPs
• Primary coordinator for company compliance specifically in the area of cleaning validation and compliance with environmental monitoring and other applicable FDA/ICH requirements with the support of QA
• Evaluates production efficiencies, variances, and procedures within the department on a continuous basis for process improvement
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POSITION QUALIFICATIONS:

Supervisory Duties:

• Manage all Manufacturing teams

Qualifications:

Education:

• Master’s degree in physical and Biological sciences or production related disciplines, plus 5 to 10 years of relevant experience 

Experience:  

• 5-10 years of experience in the pharmaceutical manufacturing industry, process scale up, and process validation.
• With team leadership or supervisory positions
• Knowledge of the Code of Federal Regulations, cGMP/ICH, and demonstration of process development and validation for pharmaceuticals and medical devices is required
• Background in data collection, computer systems, chemistry, biology, an/or microbiology is preferred

‍Physical Demands:

• Travel:  10-25%

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RESPONSIBILITES/DUTIES

The Manufacturing Technician reports to the Manufacturing Manager and the Process Development Manager depending on the task. This position’s primary function is manufacturing.

‍General

• Assist Clinical Manufacturing Engineer in the manufacture of Thrombosomes®, Placebo Controls, non-clinical products, and other Cellphire products.
• Under the direction of Senior Management, support manufacturing process development of Thrombosomes® and other Cellphire products.
• Work within controlled/classified spaces (ISO standard) to include (but not limited to) 10K rooms, 100K rooms, hoods, etc. This includes maintaining sterile gowning certification and cGMP/cGLP training (coverall, scrubs, masks, boots, hoods and goggles)
• Record, analyze, and report results in a timely manner.
• As needed, collect surface and air sampling to assure environmental quality.
• Develop and/or review Cellphire Standard Operating Procedures
• Work within cross-functional teams
• Ensure process and project documentation is accurate and updated.
• Maintain safe working environment.
• Follow Cellphire policies and procedures.
• Train and demonstrate tasks as required.
• Other duties as needed or assigned.

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Bachelors or Associates degree in a scientific field (or 3 years pharmaceutical manufacturing experience)

Experience:  

• 3 years pharmaceutical manufacturing experience

‍Physical Demands:

• Travel:  Less than 5%

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RESPONSIBILITES/DUTIES

THE QUALITY CONTROL (QC) LABORATORY TECHNICIAN IS AN ENTRY LEVEL, NON-SUPERVISORY TECHNICAL POSITION  AT CELLPHIRE.

The QC Laboratory Technician assists scientific staff and supports laboratory-based investigations by undertaking a range of routine technical and experimental tasks. The QC Technician reports to the Quality Control Laboratory. Primary role is quality control testing.

General

• Perform quality control (QC) testing of raw materials, finished Cellphire products, and research & development materials to include (but not limited to) hematology testing such as flow cytometry, thromboelastography, aggregation, thrombin generation analysis, etc., chemistry testing, such as total organic carbon analysis, as well as other testing not yet defined
• Record, analyze, and report results/data in a timely manner
• Demonstrate and train new staff when necessary
• Write reports, reviews, and summaries
• Present results and finding to Senior staff
• As needed, collect surface and air sampling to assure environmental quality
• Develop and/or review Cellphire Standard Operating Procedures
• Work within cross-functional teams
• Ensure process and project documentation is accurate and updated
• Maintain safe working environment
• Follow Cellphire policies and procedures
• Other duties as needed or assigned

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Minimum educational level: Bachelor’s degree in Scientific Field (Biology, Chemistry, etc.)

Experience:  

• Minimum 1-3 years experience in a QC environment
• Minimum 1-2 years experience in a GMP environment

Preferred Qualifications:

• Experience with bloodborne pathogens
• Employment with a biopharmaceutical company

Physical Demands:

• Travel:  As required

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RESPONSIBILITES/DUTIES

THE RESEARCH ASSOCIATE IS NON-SUPERVISORY, EXEMPT, TECHNICAL POSITION AT CELLPHIRE.

General

• Research Associate is responsible to perform routine laboratory experimentation with direction from Staff Scientist
• Specifically, this position is to work within the thrombotic group at Cellphire
• Previous experience in hematology focused on blood coagulation or platelet biology is preferred but not necessary with other skill sets
• Basic laboratory skills like pipetting are required and other skills are preferred like ELISA, aggregation assays, research & development materials to include (but not limited to) hematology testing such as flow cytometry, thromboelastography, aggregation, thrombin generation analysis, etc.
• A general willingness to work with others, interest in your duties, and understand how your work fits into the larger picture here at Cellphire
• Record, analyze, and report results/data in a timely manner
• Demonstrate and train new staff when necessary
• Write reports, summaries and presentations.
• Present results and finding to Senior staff
• Maintain safe working environment.
• Follow Cellphire policies and procedures.
• References upon request

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Bachelor’s or Master’s degree

Experience:  

• At least 2 years of professional experience, preferred
• Hematology/hemostasis experience preferred

‍Physical Demands:

• Travel:  5% (mostly for external training)

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RESPONSIBILITES/DUTIES

With funding support from DHHS Biomedical Advanced Research and Development Authority (BARDA) Cellphire is developing Thrombosomes®, a lyophilized human platelet-derived hemostatic agent as a potential medical countermeasure for Acute Radiation Syndrome (ARS). Cellphire is also developing a cryo-preserved platelet product with funding from DOD to ensure blood supplies to the United States warfighter.  Reporting to the Director of Program Management, the Project Manager will plan and track completion of program milestones, schedule, and budget.  

A successful candidate will be detail-oriented and demonstrate the willingness and ability to contribute to areas outside of his/her job description.

‍General

• Building and maintenance of Integrated Master Schedule.
• Work with program manager and finance to build and track program budgets.
• Prepare monthly Earned Value Management (EVM) reports.
• Assist with the writing of Federal Acquisition Regulations (FAR)-compliant subcontracting and consulting agreements.
• Organize and maintain key documents on internal and external document portals.
• Write meeting minutes for internal and external meetings and track action items to closure.
• Conduct FAR compliance audits including timesheets, materials usage, and Government Furnished Equipment (GFE) as required.  
• Ensure government-funded travel of Cellphire employees, subcontractors, and consultants is compliant with Joint Travel Regulations (JTR).
• Manage process improvement projects as required.
• Work with project teams to identify, document, and manage program risks.
• Work within cross-functional teams.
• Ensure process and project documentation is accurate and updated.

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Bachelor of Science degree in a physical science, life science or engineering discipline is preferred.
• Candidates with finance or accounting degrees with project management and familiarity with EVM reporting also will be considered.

Experience:  

• 3-5 years of experience project scheduling/management experience in the Biotech/Pharmaceutical Industry preferred. Prior exposure to EVM and government-funded programs a plus.

Additional Skills:  

• Must be familiar with Microsoft Project, and Microsoft Office Suite Products including MS Word, Excel, and PowerPoint.  SharePoint and Visio experience are desirable but not required.  Basic understanding of FDA regulations and the biologics development process desired.  Familiarity with FAR also is a plus.
• A successful candidate will possess strong analytical and problem-solving skills, effective writing and verbal communication skills, a demonstrated ability to work well with others and to multi-task when required.
• The candidate must be willing to work in a fast-paced biotechnology environment and to work a flexible schedule on short notice.  Late-night and weekend work will be required occasionally but not routinely.  

‍Physical Demands:

• Travel:  Limited travel may be required.

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RESPONSIBILITES/DUTIES

To coordinate and execute activities which provide support to all employees who use technology to perform their jobs. To support IT initiatives which enhance performance, enforce IT security, and maintain system availability to the entire organization.

‍General

• The position will assist in all desktop, and network support activities to include identifying, researching, referring, and resolving issues as they are presented.  These issues will include, but are not be limited to, network connectivity, IT security response, basic phone system support, desktop support, system installation and configuration, application support, etc.  The incumbent will be responsible for responding to user requests for approved hardware, software, and service changes. Should the incumbent determine that corrections are not apparent or remedial actions are not documented, this person has the authority to communicate with, or attain assistance through internal escalations, support vendors, or other applicable personnel, to ensure timely resolution.
• The incumbent will have the responsibility to make recommendations to direct reports, to shutdown systems or revoke system privileges if security breaches are suspected.  
• The incumbent will also be responsible for the complete documentation of each issue to provide future reference and change control management.  Furthermore, along these lines, this position will be accountable for collecting and maintaining data about the organization’s technology assets.
• This individual will be responsible for identifying, prioritizing, and resolving reported problems, solving routine software, hardware, and procedure problems using appropriate resources including but not limited to computer, Internet, and manuals.  The incumbent will communicate with management staff to determine requirements for new or modified software and hardware, and will install new hardware and software as required, including system updates and patches.
• To successfully accomplish these tasks, the incumbent must routinely keep abreast of software and hardware trends and the available products within the industry.
• The most difficult aspect of this position is having the ability to recognize and analyze problem situations concerning the issues that have been directed to the help desk to resolve them expeditiously and comprehensively.

Primary Accountabilities

• Serves as IT project team member and provide necessary support and reporting as required by the <Reporting Supervisor/Manager>.
• Responds to all requests for assistance as directed.
• Responds to all requests for assistance as directed.
• Resolves user issues; support and monitor all open tickets and work orders ensuring that subjects and resolutions are aligned with internal policies and procedures.
• Maintains call logs and operating procedure documentation.
• Documents equipment and software installations, including servers, workstations, mobile computing, network appliances and applications.
• Maintain reasonable response times for user problems and resolutions.
• Monitors and response to any system or automated alerts, requiring immediate attention.

System Access

• The incumbent will have Administrator level access to approved systems, for the sole purpose of enabling policy drive restrictions and insuring system availability through optimized configuration. This will include view, add, update, and delete capabilities to user security to administer user id’s, passwords, additions and terminations.  
• Privileged use access to core infrastructure systems along with administrative access to portal or cloud-based systems, as required.

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Degree or Certification  

Experience:  

• 2+ years’ experience in help desk and/or PC support roles, or equivalent work experience

Additional Skills:  

• Ability to work independently and proactively
• Working knowledge of LAN and WAN environments
• Exposure to wireless routing and access points
• Exposure to mobile device support, including mobile phones and laptops
• Good communication skills, both written and verbal
• Windows 10, Windows Server, Storage Administration
• Virtualization technologies including Microsoft Hyper-V Server and Workstation
• Exposure to Office 365 and Azure tenant administration is a PLUS (Microsoft Cloud Administration, including Azure Active Directory, VM deployment, Server Migration, etc.)  

Physical Demands:

• Travel:  N/A

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