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Employment Opportunities with BioVex
Any job vacancies will be advertised in the
relevant media and posted on this site. Please bookmark this page
and check back regularly if you're interested in working for BioVex.
BioVex's lead cancer program, OncoVEXGM-CSF,
is an oncolytic vaccine that selectively destroys tumor cells accompanied
by the induction of a systemic immune response. OncoVEXGM-CSF is
currently completing a Phase II clinical trial for melanoma and
Phase I/II clinical trials for head & neck cancer and pancreatic
cancer. Preliminary data from these studies has been very encouraging demonstrating
OncoVEXGM-CSF has the potential to treat both
local and metastatic disease. The Company is currently preparing for
a Phase III registration study in melanoma where multiple responses
have been demonstrated in an ongoing Phase II trial testing OncoVEXGM-CSF as
stand alone therapy in patients with un-resectable stage IIIc and stage
IV metastatic disease.
All of the positions below are based in Woburn,
MA, USA.
Please send resumes to hr@biovex.com.
No phone calls please.
VP of Clinical Development
This individual will report to the Chief Technology Officer
PURPOSE OF POSITION:
Responsible for the execution, monitoring, analysis and reporting
of clinical trials that meet the standards of excellence for ethics,
scientific merit and regulatory compliance, as well as satisfy corporate
goals for approval of products.
RESPONSIBILITIES
- Monitor all of the company’s trials in accordance with FDA
Good Clinical Practice Guidelines (GCP) and full compliance with
all national and international regulatory requirements.
- Assist in preparing overall clinical development strategies that
lead to global product registrations. This includes the design of
Phase 1, 2 and 3 clinical trials
- Oversee pharmacovigilance activities and data from planned phase
III study and other clinical trials.
- Contribute in an active and ongoing manner to the scientific, clinical
and commercial development of current and future product candidates
(internally and externally developed).
- Represent the company as needed as a senior medical spokesperson
to a variety of scientific, business and government groups/agencies
EDUCATION/SKILL/EXPERIENCE REQUIREMENTS
MD degree from an accredited institution and experience in oncology.
A minimum 5 years experience in a clinical research environment
with exposure to the drug development process and participation in
the design and monitoring of clinical trials.
Please refer to Job Code CL02 when corresponding about this position.
Please send resumes to hr@biovex.com.
Clinical Project Manager
This position will manage various activities related to all clinical
research studies and projects according to Federal Regulations and
ICH guidelines.
- Lead a clinical study team and vendors, and ensure the successful
implementation of a clinical study in accordance with ICH/GCP guidelines
through oversight of cross-functional study planning
- Set-up, execution, reporting, identification and resolution of
issues
- Communication of study timelines/deliverables
- Assist with various activities as required. These activities
may include:
- Protocol and study design
- Identification and management of clinical study sites/ investigators
- Case Report Form design
- Informed Consent design
- Develop project/ study operations manual
- Regulatory document preparation and submission
- Conduct/ oversight of various types of clinical site visits
- Participation in CRF and data listings review, data audits, and
status report preparation
- Primary Liaison with resources and other support for study (central
laboratories, electronic data capture, etc.)
- Oversight of study contacts and budgets
- Review of data management and analysis plans
- Assurance of compliance with program time lines
This position requires a Bachelors Degree in Science or related and
a minimum of 4 years experience in clinical research in the pharmaceutical
field with drug development experience preferred. Current in-depth
knowledge of the FDA’s Good Clinical Practices guideline, clinical
trials monitoring and regulatory compliance desired. Must also
have full scope understanding of site monitoring and associated documentation
requirements. This is a full time permanent office based position
and requires approximately 15-20% domestic and international travel.
Quality Assurance Supervisor, Compliance
We are seeking a Quality Assurance Supervisor to
execute Quality Systems in our BioVex GMP manufacturing plant in Woburn,
MA.
The Quality Assurance Supervisor is responsible for supervising the
QA release and QA compliance functions within the BioVex Woburn facility. Assists
Quality Management in ensuring that all relevant quality and regulatory
requirements are met for production, testing and release of clinical
product lots, and that site complies with US and international Quality
System Regulations. Candidate should have prior experience in
an FDA-regulated environment, or equivalent.
Job functions include performing or supervising QA activities
including:
- Set up and maintenance of Quality Systems
- Review and approval of controlled documentation including procedures,
specifications, batch records, validation protocols and reports
- QA release activities including review of completed batch records
and test data, and disposition of product
- Support QA compliance activities including QA audits, internal
and external
- Execute Quality Systems including deviation resolutions, tracking
corrective & preventative actions
- Provide support to regulatory submissions regarding Chemistry & Manufacturing
Controls (CMC), to facilitate FDA approvals
- Interfacing with internal customers in Manufacturing, QualityControl
Laboratories, and Product Development
- Ensure compliance with company and FDA quality standards
This position requires a B.A or B.S. degree in an appropriate scientific
field, and 3+ years experience in Quality Systems and/or supervision
in an FDA regulated biotechnology, pharmaceutical or diagnostics industry
environment. Previous supervisory experience preferred.
Manufacturing Supervisor
Manufacturing Supervisor
The Manufacturing Supervisor is responsible for the cGMP execution
of operation systems according to Standard Operating Procedures (SOP's).
The candidate will be responsible for the activities of a production
staff in a cGMP environment for cell culture, purification and fill
finish activities.
Job Responsibilities:
- Supervise and participate in all aspects of cGMP biologics manufacturing
for the generation of viral-based products involving mammalian cell
culture.
- Review executed documents for compliance to documentation practices.
- Implement and maintain manufacturing production schedules, and
assist in the coordination of manufacturing resources and production
suites to ensure the successful completion of production goals.
- Write and review cGMP documentation including SOPs, material and
product specifications, investigations, and batch documentation.
- Participate in the technology transfer of operations from Process
Development/Engineering groups to cGMP manufacturing operations.
- Coordinate activities involved in cGMP manufacturing; purification
and filtration techniques and product fill/finish operations.
- Participate in performance evaluation, training and general supervision
of manufacturing staff.
Requirements:
- Minimum six years of cGMP manufacturing experience.
- Preferably previous supervisory experience in a manufacturing environment.
- Work experience in cGMP biologics manufacturing operations with
a strong emphasis and demonstrated proficiency in cell culture operations.
BioVex is nearing completion of the construction of our manufacturing
facility and headquarters at 34 Commerce Way, Woburn, MA. The facility
will manufacture OncoVEXGM-CSF to support our phase 3 clinical trial
and commercial launch. We are currently sourcing experienced
qualified candidates to set up operations, support validation, transfer
the process and begin manufacturing.
Please send resumes to hr@biovex.com.
No phone calls please.
Manufacturing Technician
The Manufacturing Technician is responsible for the execution of clinical
operation or development systems according to Standard Operating Procedures
(SOP's). The candidate will work in a cGMP (current Good Manufacturing
Practices) manufacturing environment.
Job Responsibilities:
The Manufacturing Technician performs a variety of complex tasks
under general guidance and in accordance with cGMPs. The Technician
Plays a role in implementing new technology into the manufacturing
process and in starting up a new manufacturing area. Performs
some or all of the following operations in strict accordance with SOPs:
preparation of bulk solutions, aseptic manipulation of cell cultures,
purification, aseptic fills and labeling of vials. Operation
of manufacturing equipment including but not limited to glass washers,
autoclaves, fill machines, and filtration equipment. Maintains
records to comply with regulatory requirements.
May participate in plant trials for evaluating process modifications. Troubleshoot
processing problems bringing issues to the attention of the supervisor,
and assists in the implementation of production procedures to optimize
manufacturing processes. May provide training to new personnel
in a specific technical process. Thorough understanding of cGMP
requirements and safety practices.
Requires a high school diploma or equivalent, certificate in Biomanufacturing,
AS degree, or equivalent experience plus a minimum of 0-2 years of
related work experience in a manufacturing environment.
BioVex is nearing completion of the construction of our manufacturing
facility and headquarters at 34 Commerce Way, Woburn, MA. The facility
will manufacture OncoVEXGM-CSF to support
our phase 3 clinical trial and commercial launch. We are looking for
experienced qualified candidates in QC, and QA to set up operations,
support validation, transfer the process and begin manufacturing.
Please send resumes to hr@biovex.com.
No phone calls please.
Process Development Scientist / Engineer
BioVex Inc. are seeking to employ a Process Development Scientist at
their Woburn facility, MA. A new Process Development team is being
established to develop, improve and scale-up drug product manufacturing
and filling processes in support of a Phase III GMP manufacturing facility.
The PD Scientist will provide technical input for production investigations
and trouble-shooting. The PD Scientist will also assist in the initial
PD laboratory set-up and technology transfer from BioVex’s UK
facility (some International travel may be required in the first 6
months).
Responsibilities of the PD Scientist will include, but are
not limited to:
- PD laboratory set up and technology transfer of production process
- Production process scale-up design, optimization and process validation
projects
- Provide process manufacturing technical support for production
and quality control in order to enhance the robustness and reliability
of processes
- Formulation development for improvement of product recovery, stability,
quality and cost effectiveness
- Perform laboratory tasks including general housekeeping, equipment
monitoring and maintenance, inventory of supplies, etc.
- Preparation of records, protocols and reports to document the development,
validation and process transfer work performed
- Interaction with external contractors for development projects
and for technical support
Education and Experience:
BS in relevant biological science or biochemical engineering,
with 3-5 years of laboratory based experience in a process development
capacity. Practical experience of fermentation and cell culture, purification
development and process engineering is a must. Computer literacy (MS
Word and Excel), good communication and organizational skills are required.
The ideal candidate will have knowledge of cGMP.
All of the positions below are based on Milton Park, near
Abingdon, UK.
Please send resumes to twilliams@biovex.com for
UK opportunities. No phone calls please
Sorry - no current vacancies
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