• 9430 Key West Avenue Rockville, MD 20850 I (240) 268.1141

Careers

At Cellphire, our commitment is reflected in all that we do, and how we do it. We are a young company driven by the collective desire to make a difference and recognize that our success depends on the creativity, dedication and hard work of our team. It is our people who make it all happen, and we believe that is especially true at Cellphire. We offer prospective employees exciting challenges, unique opportunities for career growth and a fast-paced growth environment that emphasizes innovation and achievement.

Cellphire's policy to offer equal employment opportunities to all qualified applicants and employees without regard to race, color, ancestry, national origin, age, religion, sex, sexual orientation, marital status, family responsibilities, genetic status, disability, veteran status, or any other characteristic protected by federal, state or local law. This policy applies to all areas of employment including recruitment, hiring, training and development, promotion, transfer, termination, lay off, compensation, benefits, and other terms, conditions and privileges of employment.

Cellphire is committed to providing reasonable accommodations to employees or applicants with disabilities in accordance with Federal and State laws so if you are applying for an open position and require accessibility assistance, please contact Richard Cliff, COO at our Rockville location.



Available Positions at Cellphire
Please send your CV/Resumes to our Operations Manager, Rob Woods. RWoods@cellphire.com


Position #1:

Title:  Quality Assurance Associate 

GENERAL RESPONSIBILITIES:
Applies fundamental quality philosophies, principles, systems, methods, tools to achieve operational excellence.
RESPONSIBILITES/DUTIES: 

  • Manages supplier management system.
  • Oversees material control system to assure effectiveness.
  • Applies statistical principles to development of sampling plans, design of experiments, interpretation of data.
  • Applies principles of continuous improvement (e.g., quality control tools, quality management and planning tools, continuous improvement methods and lean tools) to product and process development/improvement/ and CAPA projects.
  • Oversees change control system.
  • Prepares quality documentation and reports by collecting, analyzing and summarizing information and trends including failed processes, stability studies, recalls, corrective actions, and re-validations.
  • Coordinates development of validations plans, protocols and reports.  Assists staff in developing validation plans, protocols, and reports.   Review and approve validation plans, protocols, and reports.
  • Develops quality assurance plans by conducting hazard analyses; identifying critical control points and preventive measures; establishing critical limits, monitoring procedures, corrective actions, and verification procedures.
  • Assists in maintenance and improvement of document control and records systems, training system, nonconformance reporting and investigations, deviation/CAPA system.
  • Maintains and improves product quality by completing product, company, system compliance, and surveillance audits; investigating customer complaints; collaborating with other members of management to develop manufacturing and training methods.
  • Supports Management Review Meetings by preparing data and presentations, developing and reporting on metrics.
  • Updates knowledge by studying trends in the developments in quality management; participating in educational opportunities; reading professional publications; maintaining personal networks; participating in professional organizations.
  • Enhances department and organization reputation by accepting ownership for accomplishing new and different requests; exploring opportunities to add value to job accomplishments.
  • Works under specific supervision of senior management.

Qualifications:

  • Education
    • Bachelor’s or Master’s degree
  • Experience
    • 5-10 Years' experience in quality assurance
    • 3-10 Years' experience in commercial GMP facility
    • Experience in quality improvement projects, project lead role a plus
    • Experience in application of statistical principles to problem solving, design and/or development projects
    • Experience in developing and maintaining quality management systems and quality assurance processes
    • Experience in materials management and supplier management systems a plus
    • ASQ Certification and/or in continuous improvement methodologies/lean tools a plus


Position #2:

Title:  Office Assistant

GENERAL RESPONSIBILITIES:

Under the direction of the Operations Manager, the Office Manager will be responsible for assisting with Human Resource Department, Operations Department, and IT Department at 9430 Key West Ave Suite 250 Rockville Maryland. This position will support both Cellphire, Inc. and its subsidiaries in all support aspects listed below:

RESPONSIBILITES/DUTIES: 

Human Resources:

  • Assist with general Human Resource activities.
    • Filing/updating employee records

Operations:

  • Assist with large item purchasing process/lease agreement negotiations
  • Assist with Corporate Credit card account
    • Run monthly breakdown reports and prepare backup documentation for every charge on the corporate credit card to reference direct charges to BARDA
    • Assist Property Control and Corporate security systems
      • Manage the Datawatch Corporate security system
      • Assist with Cintas ordering/Inventory
      • WASP Inventory System
      • Manage all office Printers/scanners
      • Help with day to day activities at Cellphire.

IT:

  • Work with Cellphire’s IT team to implement new systems
  • Assist all Cellphire staff with Computer issues.

Qualifications:

  • Education: Bachelor’s degree in Business related field
  • Experience: 2-5 years’ experience handling Accounting, Human Resource, IT, Finance, and/or Government Contracting.




Position #3:
Title: Biostatistician/Analytical Research Scientist

GENERAL RESPONSIBILITIES:

The Biostatistician/Research Scientist will report directly to the Head of R&D for job activities and responsibilities. Routinely work with lab & manufacturing staff on collecting data and performing analytical development. Candidate must be self-motivated and able to work in a team-based environment.

RESPONSIBILITES/DUTIES:

  • Contributes to statistical methods research
  • Prepare statistical data for inclusion in reports to data monitoring committees, federal regulatory agencies, managers, and consultants.
  • Provide biostatistical consultation to clients or colleagues.
  • Analyze clinical or survey data using statistical approaches
  • Prepares tables, figures, and written summaries of study results. Interprets results in collaboration with other scientists and helps prepare abstracts, presentation and manuscripts.
  • Maintains the quality of the technical output and the performance of the programs in compliance with GLP and/or cGMP/ICH regulations, standards, and guidelines as required
  • Support product, process, and formulation development through analytical method development qualification and testing under direction of Head of R&D
  • Experimental design and interpretation & management of data.
  • Review and analyze data to identify trends.
  • Participate in analytical development for the analytical lab
  • Routine work involvement and weekly meetings with R&D team to review progress, work through issues and bring resolution to problems, and communicate to laboratory management and coordinate with other leaders for assistance and closeout of work activities.
  • Assist in maintaining a clean, safe workplace on a daily basis. 
  • All other duties as assigned.

Qualifications:

  • Education
    • Master’s degree or PhD in Biostatistics with experience in Biostatistics
    • Or Bachelor’s degree in Chemistry, Biochemistry, or Material Science & Biostatistics with 5-10 years of experience focusing on biostatistics
  • Experience
    • Analytical Chemistry, drug development, and biologics
    • Experience running Chromatographic techniques (HPLC, GPC, or SEC), Gas Chromatography, Microscopy, Physical Characterizations, Polymer science would be appreciated




Have Questions?Reach us here

Please enter your information below

The Cellphire Method

Cellphire has developed a proprietary method for the stabilization of blood in the dry state. First application of this technology will be the long term stabilization of blood platelets (freeze-dried platelets).