‍POSITION QUALIFICATIONS:

Education:

• Master’s Degree in Accounting or Finance, CPA preferred.

Experience:  

• At least 12-15 years of accounting experience with managerial responsibility.
• Experienced leader with high degree of knowledge of general accounting theories, principles, and practices with a solid knowledge of general budgeting principles and practices.
• Experience as a controller or senior level accountant at a public company.
• Experience with hands on preparation and review of incurred cost submissions and forward pricing rates.
• Experience being the lead on successful government audit(s).
• Solid understanding of government indirect rate structures and competitive pricing practices.
• Ability to plan and prepare an annual corporate budget as well as completing monthly, annual, and multi-year business forecasts.
• Preferred, at least 3 years as a Controller with a government contractor.
• Government contract accounting experience and a working knowledge of FAR/CAS requirements.
• Experience with FFP, T&M and Cost-plus contracts.
• Experience with Contract management and preparation of cost proposals and supporting documentation.

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

General

• Designing experiments capable of addressing scientific questions in a logical manner.
• Recording, analyzing, and organizing data and results in a timely manner.
• Accurately communicating  results to senior staff in the form of reports, summaries, and presentations.
• Working safely and efficiently  in a BSL-2 lab environment.
• Following Cellphire policies and procedures.
• Training new staff when necessary.
• All other duties as assigned.

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POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Minimum of a Bachelor’s degree
• Educational background in chemistry, biochemistry, cell biology, organic chemistry, pharmaceutics, or related field.

Experience:  

• 1 year of prior lab experience
• Required skills include pipetting, measuring pH, weighing reagents, and calculating molarities/concentrations.
• Preferred skills include:  ELISA, flow cytometry, thromboelastography, aggregation, thrombin generation analysis, gel electrophoresis, and microscopy.
• Previous experience in hematology focused on blood coagulation or platelet cell biology is preferred, but not required.
• Prior industry experience preferred.
• References upon request.

Additional Skills:

• Ability to work within the Research Discovery group at Cellphire, performing routine laboratory experimentation with direction.
• A willingness to work with others, an interest in the previously described duties, and an understanding of how their work fits into the larger picture here at Cellphire.

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RESPONSIBILITES/DUTIES

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

‍General

• The selected candidate will work within the thrombotic group at Cellphire, performing routine laboratory experimentation with direction.
• Designing experiments capable of addressing scientific questions in a logical manner.
• Recording, analyzing, and organizing data and results in a timely manner.
• Communicating results to senior staff in the form of reports, summaries, and presentations.
• Following Cellphire policies and procedures.
• Training new staff when necessary.
• All other duties as assigned.
• References upon request.

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‍POSITION QUALIFICATIONS:

Supervisory Duties:

• N/A

‍Qualifications:

Education:

• Minimum of a bachelor’s degree

Experience:  

• 2 years' experience with education background in chemistry, biochemistry, cell biology, organic chemistry, pharmaceutics, or related field.
• Mandatory experience in blood cell biology.
• Previous experience in hematology focused on blood coagulation or platelet biology is preferred, but not required.
• Previous in-vivo experience preferred but not necessary.
• Required skills include pipetting, measuring pH, weighing reagents, and calculating molarities/concentrations.
• Preferred skills include: ELISA, flow cytometry, thromboelastography, aggregation, thrombin generation analysis, gel electrophoresis.

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