All of the positions below are based in Woburn,
MA, USA.
Curent Vacancies
Please send resumes to hr@biovex.com.
No phone calls or faxes please
Director / Senior Director, Quality
Control
Summary of Job Description:
The Director / Senior Director, Quality Control (QC) is responsible for the
leadership and organization of Quality Control team at BioVex. A key role
of the Director will be to ensure that the QC function is operating efficiently
and able to support applications for marketing approval and commercial supply.
The QC team is responsible for activities that include: raw materials testing,
product testing, in-processing testing, stability testing and EM testing
for air, surfaces, water systems, and air/gas distribution systems in support
of Phase III production and commercial supply. The Director will ensure that
this work is planned, performed and reported in an efficient and compliant
manner. The Director will be responsible for all QC activities, focusing
on areas related to batch review and product release testing to assure timely
supply of product. The Director will also be responsible for technology transfer
of QC assays and validation of test procedures / sites. Additional studies
will also be required to be managed in support of regulatory submissions
i.e. stability, comparability and characterization testing. The Director
will provide technical expertise for laboratory investigations and follow
through on close out actions. The Director will be responsible for ensuring
all data reports and documentation to support regulatory submissions are
available on schedule.
This position is based at BioVex’s Woburn facility,
MA, USA, and reports to the Vice President of CMC.
Key Responsibilities
- Leadership and direction of the QC team at BioVex (both UK and
US based groups)
- Management of QC activities including raw materials
testing, product testing, in-processing testing, stability testing, environmental
monitoring and utilities supply testing (gas / air)
- Provide oversight
for laboratory investigations and reports in response to OOS, invalid assays,
aberrant trends / results, and manufacturing investigations
- Implement
and maintain Quality and Compliance systems for QC group in accordance with
current International GMPs and Regulatory requirements
- Responsible
for technology transfer of QC assays and validation of test procedures /
sites
- Supervises creation and completion of records, protocols
and technical reports to document the development, validation and assay transfer
work performed
- Interaction with external vendors for QC testing
and for technical support
- Preparation of reports and regulatory
documents in support of submissions to regulatory authorities
- Provide
regular updates of QC group activities to the VP of CMC and other BioVex
senior management
Other Responsibilities
- Responsible for management of Quality Control milestones and
establishes objectives for and appraises QC staff
- QC representative
for cross function meetings / projects with manufacturing, QA, Regulatory
Affairs and external partners
- Ensure data analysis, trending and
QC specifications remain current
- Application of sound scientific and
current regulatory knowledge for the planning and execution of QC projects
- Provide
QC review and approval of Policies, Operational Standards, SOPs, validation
protocols and reports.
- Assist in the preparation of department expense,
capital and headcount budget
- Some travel will be required
Educational Requirements:
B.A or B.S. degree in a relevant biological science and extended relevant commercial
experience. M.S., Ph.D. or other post-graduate degree in biochemistry or
related science is preferred.
Experience and Skill Requirements:
- A minimum of 10 years experience in a cGMP Quality environment
and 5 years in a senior managerial role; or equivalent combination of education
and experience
- Thorough understanding of current regulatory requirements
and practical experience of QC testing in support of cGMP operations supporting
clinical and commercial manufacturing, ideally including international experience
- Proven
leadership in managing and motivating team members to achieve QC goals
- Ability
to interface effectively with management and other groups, project teams
and personnel at manufacturing site
- Computer processing literacy
and experience in statistical analysis
- Excellent verbal and written
communication skills and a track record of preparing documentation in support
of regulatory submissions.
Please send resumes to hr@biovex.com. No
phone calls or faxes please.
[posted 16 June 2010]
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Director / Senior Director, Process
Development
Summary of Job Description:
The Director / Senior Director, Process Development is responsible for the
leadership and organization of Process Development team at BioVex. Develops
and manages the PD staff performing the Process Development projects and
activities.
The Process Development team is responsible for the development,
improvement and scale-up of drug product manufacturing, formulation and filling
processes in support of Phase III production and commercial supply. The Director
will ensure that this work is planned, performed and reported in a methodical
and efficient manner. The Director will oversee technology transfer and validation
of production processes. The Director will work closely with associated groups
to define critical process parameters and quality attributes. The Director
will provide technical expertise for production investigations and trouble-shooting.
The Director will be responsible for ensuring all reports and documentation
to support regulatory submissions are available on schedule.
This position
is based at BioVex’s Woburn facility, MA, USA, and reports to the Vice
President of CMC.
Key Responsibilities
- Leadership and direction of the Process Development team at BioVex
(both UK and US based groups)
- Management of process development,
process scale-up, optimization, technology transfer and process validation
projects
- Responsible for establishing critical process parameters,
process controls and process analytical technology for commercial processes
- Process
and formulation development for improvement of product recovery, stability,
quality and cost effectiveness
- Provide process manufacturing technical
support for operations and quality control in order to enhance the robustness
and reliability of processes
- Supervises creation and completion of
records, protocols and technical reports to document the development, validation
and process transfer work performed
- Interaction with external vendors
for development projects and for technical support
- Preparation of
reports and regulatory documents in support of submissions to regulatory
authorities
- Provide regular updates of Process Development group
activities to the VP of CMC and other BioVex senior management
Other Responsibilities
- Responsible for management of Process Development milestones
and establishes objectives for and appraises PD staff
- Application
of sound scientific, engineering and current regulatory knowledge for the
planning and execution of the projects
- Technical liasion between
PD, manufacturing, QC/QA and external partners regarding scale up, validation
and commercial manufacturing activities
- Evaluation and implementation
of new technology that will improve the quality, compliance and cost effectiveness
of production processes
- Assist in the preparation of department expense,
capital and headcount budget
- Some travel will be required
Educational Requirements:
B.A or B.S. degree in a relevant scientific field. M.S., Ph.D. or other post-graduate
degree in biochemical engineering, or a relevant biological science, and
/or extended relevant industrial experience is preferred.
Experience and Skill Requirements:
- 10 - 15 years experience in biotechnology / pharmaceutical industry,
with good knowledge of GMP requirements and a proven history of technical
accomplishments
- Thorough understanding and practical experience of
fermentation and cell culture, purification development and process engineering
- Practical
knowledge of process validation and PAT to control processes
- Proven
leadership in managing and motivating team members to achieve process development
goals
- Ability to interface effectively with management and other
groups, project teams and personnel at manufacturing site
- Computer
processing literacy and experience in utilization of statistical experimental
design techniques
- Excellent verbal and written communication skills
and a track record of preparing documentation in support of regulatory submissions.
Please send resumes to hr@biovex.com. No
phone calls or faxes please.
[posted 16 June 2010]
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Process Development Scientist / Engineer
Summary of Job Description:
The Process Development Scientist/Engineer will assist in the development,
optimization, scale-up and validation of the purification process at BioVex
Woburn. The PD Scientist/Engineer will also provide downstream technical
support for cGMP manufacturing, review process documentation and generate
study reports to support a BLA filing.
Key Responsibilities
- Design and execution of studies in support of process scale-up, optimization
and validation
- Process development for improvement of product recovery, stability, quality
and cost effectiveness
- Conduct data analysis, prepare protocols and reports
- Work closely with all internal stakeholders within process development
as well as other groups such as manufacturing and quality control
- Interaction with external vendors for development projects
- Downstream processing technical support for cGMP manufacturing
- General laboratory housekeeping, equipment monitoring and maintenance,
inventory of supplies, etc.
Educational Requirements:
Professional degree (B.S. or higher) in a relevant technical discipline
Experience and Skill Requirements:
- At least 3 years laboratory based experience in downstream purification
development
- Must be able to demonstrate a solid understanding of protein separation
techniques
- Direct experience with tangential flow filtration and column chromatography
- Strong written and verbal communication skills, including report writing
skills
- Excellent problem solving skills, experience in DOE and statistics
- Ability to work in a fast paced multi-disciplinary team environment
- Proficient in Microsoft Office (Word, Excel, Outlook)
- cGMP experience and knowledge of current industry practices will be beneficial
Please send resumes to hr@biovex.com. No
phone calls please.
[posted 20 May 2010]
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Process Development Scientist
Summary of Job Description:
The Process Development Scientist will assist in the development, optimization,
scale-up and validation of the mammalian cell culture process at BioVex Woburn.
The PD Scientist will also provide upstream technical support for cGMP manufacturing,
review process documentation and generate study reports to support a BLA
filing.
Key Responsibilities:
- Execution of studies in support of process scale-up, optimization and validation
- Conduct data analysis, prepare protocols and reports
- Routine passaging of maintenance cultures
- General laboratory housekeeping, equipment monitoring and maintenance,
inventory of supplies, etc.
- Work closely with all internal stakeholders within process development
as well as other groups such as manufacturing and quality control
- Upstream processing technical support for cGMP manufacturing
- Interaction with external vendors for development projects
Education and Experience:
Professional degree (B.S. or higher) in a relevant technical discipline
Skill Requirements:
- At least 1-3 years laboratory based experience in cell culture
- Able to demonstrate a solid understanding of cell culture and aseptic technique
- Direct experience with adherent mammalian cell lines
- Strong written and verbal communication skills, including report writing
skills
- Excellent problem solving skills
- Ability to work in a fast paced multi-disciplinary team environment
- Proficient in Microsoft Office (Word, Excel, Outlook)
- Experience with NOVA/YSI instrumentation will be beneficial
Please send resumes to hr@biovex.com. No
phone calls please.
[posted 20 May 2010]
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Clinical Research Associate
Summary of Job Description:
The Clinical Research Associate will monitor activities at clinical study sites
to assure adherence to ICH-GCPs, SOPs, and study protocols. Responsible for
multiple projects and must work both independently and in a team environment.
Participate in the study development and start-up process including reviewing
protocols, designing and/or reviewing CRFs, preparing Informed Consent forms,
developing study documents, organizing and presenting at investigator meetings,
working with management on monitoring strategy, and/or developing project-specific
CRA training.
Key Responsibilities:
Ensures compliance with protocol and overall clinical
objectives.
Other Responsibilities:
- Review regulatory documents as required
and prepare site visit reports.
- Contributes to the site and investigator
selection process by making appropriate recommendations.
- Performs
site qualification visits to evaluate site facilities and staff to ensure
protocol and Federal Regulations will be adhered to.
- Performs and facilitates
study start-up activities including site initiation and training, providing
site level information for country recruitment plan, and evaluate site recruitment
activities.
- Conducts on-site visits to ensure clinical investigative
sites are complying with study protocols, FDA regulations, ICH Guidelines
and GCPs, including confirming patient eligibility, protocol compliance,
tracking patient enrollment, reviewing informed consent forms, maintaining
project and visit timelines, ensuring accurate transcription of data from
source documentation to CRF/EDC and addressing data inconsistencies and clarification
with the site staff.
- Build and maintain professional relationships with clinical
investigative sites by communicating in an effective, consistent and timely
manner.
Educational Requirements:
Professional degree (B.S. or higher) in a relevant
discipline.
Experience and Skill Requirements:
- 2-3 years in a similar
position in the biotechnology/pharmaceutical/CRO industry
- Knowledge
of ICH-GCP guidelines, and medical terminology
- Excellent communication
skills (written and verbal)
- Strong computer skills, ability to develop
and maintain excel spreadsheets
- Strong organizational skills with attention
to details
- Willingness to travel approximately 20%.
Please send resumes to hr@biovex.com. No
phone calls please.
[posted 12 May 2010]
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Quality Assurance Team Leader
Summary of Job Description:
The Quality Assurance
Team Leader will supervise, lead, plan, organize, guide, and monitor
employee accomplishments within the QA group at BioVex Woburn to assure
efficient and effective contribution to organization objectives. Focus is on a quality system approach with the manufacturing
department and to work closely with other departments/groups to maintain
a high level of quality in execution and documentation of drug products
manufactured at the Woburn facility. Responsible for managing
assigned staff to ensure objectives and deliverables are understood
and met.
Key Responsibilities:
- Manage the batch review program to ensure timely release of drug
product.
- Facilitate EU batch record review and Qualified Person release
of products manufactured in Biovex Woburn.
- Maintain and manage the internal and external audit program for
US activities. May lead and direct audits of GMP materials
and service providers.
Other Responsibilities:
- Manage QA review of change controls and deviations pertaining to
Operations.
- Facilitate the establishment, implementation and maintenance of
Woburn Quality Management Systems in accordance with applicable standards
established by FDA, MHRA, and other regulatory bodies.
- Interact routinely with QA Compliance and Document Control staff
in Woburn and interface routinely with QA staff in Milton Park, UK.
- Support QA management of regulatory inspections.
- Interfaces with internal customers in Product Development, QC,
Manufacturing, etc. and, as appropriate, with external vendors to
support ongoing compliance with BioVex requirements and quality standards.
- Draft, review and provide oversight to content and/or approve documents
which may include but are not limited batch records, material specifications,
SOPs, and Quality Agreements.
- QA review of submissions made to regulatory agencies such as MHRA
and FDA, regarding products manufactured at Woburn.
- Input into the development and implementation of Chemistry, Manufacturing
and Controls regulatory activities in Woburn to facilitate FDA approval
of the Company’s manufacturing facility and products.
Educational Requirements:
Professional degree (B.S. or higher) in a relevant technical discipline
Experience and Skill Requirements:
- At least 5 years experience in relevant quality systems, technology
and/or supervision in an FDA-regulated biotechnology or pharmaceutical
environment.
- GMP and GLP auditing experience.
- Strong communication (written and verbal), supervisory, organizational,
and interpersonal skills
- Detailed familiarity with cGMP requirements and current industry
practices
- Proficiency in relevant computer software
- Demonstrated ability to work in a cross-functional team environment
Please send resumes to hr@biovex.com. No
phone calls please.
top
All of the positions below are based on Milton Park, near
Abingdon, UK.
Curent Vacancies
Process Development Scientist
A Process Development scientist is
required to help develop and optimise the production process for producing
herpes simplex vectors for oncology and vaccine applications.
The successful
candidate will have a minimum of a degree in a relevant science subject
and 2-3 years experience working within the Pharmaceutical/Biotech
industry. Experience of cGMP and GLP is desirable. Tissue culture experience
(preferably mammalian) is a requirement of the role. An understanding
of virus/protein purification and chromatography would also be an advantage.
As part of a multi disciplinary project team the candidate should possess
excellent communication skills and an ability to meet deadlines through
flexible and creative problem solving.
Please send cover letter, including CV and Full remunerations details,
to Tina Williams at BioVex Ltd, 70 Milton Park, Abingdon, Oxon, OX14
4RX or Email twilliams@biovex.com for
UK opportunities.
No agencies
[posted 7 April 2010]
