Employment Opportunities with BioVex

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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

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