VaxGen provides an exciting, enthusiastic and challenging environment and has the following job openings:
Clinical Research Associate II – 21011402 VS
Responsibilities:
Clinical Study Monitoring
• Responsible for in-house clinical monitoring of CRF data
• Conducts field visits and monitors regulatory and protocol adherence at study sites
• Develops monitoring schedule and modifies according to study progress
• Assists in the maintenance and development of clinical SOP documents
• Oversees the negotiation of vendor contracts and maintenance of vendor relationships
• Oversees tracking of payments to study centers
• Develops monitoring practices and data edit check/queries
Clinical Study Management
• Contributes to the development of CRF clinical monitoring procedure/conventions/guidelines in
cooperation with CPM
• Works in cooperation w/ CPM and clinical team in the management of CLAB issues
• Assists in the development of a monitoring compliance plan
• Assists in the selection and management of central laboratory services
• Assists in the evaluation and selection of new investigators w/ Sr. CRA
• Works with CRA team to present clinical issues to the Project Team
• Provides continuity and value in the ongoing discussions regarding clinical monitoring issues
• Provides input to the team on what is needed to address regulatory queries that arise throughout
study conduct
• Provides training and direction to junior CRA’s and/or assistants in order to familiarize with issues
related to study conduct
• Integrates skill set to CRA team in order to optimize the developmental opportunities available to the
team
• Recommends and/or creates avenues to coordinate VAX003 and VAX004 monitoring practices and
data edit checks/queries
Minimum Requirements:
• BA/BS required
• Minimum of 2 years Biotech or Pharmaceutical monitoring experience in a clinical/medical affairs department
• Excellent oral and written communication
• International experience preferable
• Laboratory experience preferred
VP or Sr. Director of Process Sciences/Manufacturing – Job Code 40120701 KW
A VP or Senior Director level candidate is being sought to lead the newly created VaxGen Manufacturing Department. This department includes the Recovery Process Sciences Group, the Cell Culture and Fermentation Group, and the Bioanalytical Chemistry Group.
This candidate will direct and be responsible for all internal manufacturing activities required to support IND and BLA filings. This includes management of outside contractors as well as internal staff. Budgeting, forecasting manufacturing needs, and resource allocation skills are a must. This candidate will be expected to recruit additional staff and participate in the design of new laboratory facilities to support the AIDSVAX manufacturing plans. Reports to the Senior VP of Research and Development.
Required:
10 years of expertise in recovery process sciences or a related field, an excellent understanding of GMP practices, a high level of experience with CMC documentation, and an excellent record of accomplishment as a manager or group leader. The successful candidate will need to be self-motivated, have excellent communication skills, and be a good people manager. Expertise in writing and assembling technical reports and SOPs to support regulatory filings is essential.
Director, Biostatistics and Programming – Job Code 31120701 MG
• Provide leadership to the department, execute corporate goals and objectives on time, and provide strategic leadership and vision to the team.
• Set goals for the department and align with goals of Medical Affairs and the company.
• Responsible for statistical methodologies, analysis programming, and report writing.
• Support professional activities, promote job satisfaction, encourage training, provide training and presentations about statistical methodology and SAS programming techniques.
• Represent department in project planning and senior or corporate level meetings, identify mission critical needs of the departments.
• Provide training / presentations to staff members on statistics and programming techniques.
• Collaborate with Clinical, Data Management, Regulatory, and Research and Development, Project Development Team and senior executives to resolve data analysis issues.
• Contribute to the implementation and execution of the product development plan, and assist in the creation of strategic objectives for BLA filing.
• Supervise the activities of manager of programming and statisticians, perform annual evaluations for direct reports, proactively resolve issues and ensure the department functions at highest efficiency
• Ensure quality implementation and timely completion of data analysis in accordance with product development plans.
• Monitor and review the BP operations to ensure efficient and accurate information processing
Required:
• MS degree in a scientific discipline, 6-8 years related experience in health care, pharmaceutical, or biotechnology industries
or a PhD degree in a scientific discipline, 4-5 years related experience in health care, pharmaceutical, or biotechnology industries, scientific programming ability in SAS, S-plus, FORTRAN or C, experience with clinical data systems and analysis process, sound knowledge of relevant FDA regulations.
• Knowledge of clinical research process, trial designs, development of protocols and analysis plans.
• Demonstrated professional excellence through publication, presentation, and external recognition.
ELISA Research Associate (2 positions) – Job Codes 42120701 MP and 42120701 MP2
Two RA level positions available in small analytical group. One position (42120701 MP) involves the characterization of immunologic response in Phase III clinical trials of the leading HIV vaccine candidate. The second job (42120701 M2) supports cell culture operations, fermentation process development, and recovery process development efforts in the making of recombinant HIV vaccine antigens. The major responsibility will be running enzyme-linked immunosorbent assays (ELISAs) to measure 1) the binding activity of antibodies generated in response to vaccination and/or 2) the concentration of antigen expressed in supernatants during stages of recovery and purification. Opportunity for methods development and characterization work dependent upon experience. This is an opportunity to work in a small group setting with training in immunoanalytical techniques.
Required:
Experience running ELISAs, excellent pipeting skills, strong laboratory math capability, and good computer skills (PC or MAC) particularly in the use of MS Excel. The ability to execute techniques precisely and consistently with attention to detail is a must. Experience with automated liquid handling workstations is a plus. Additional skills of value include analytical methods development, SDS-PAGE/Western blotting, affinity chromatography, quantitative analysis, FPLC/HPLC, graphics software such as MS Excel charts or DeltaGraph, and familiarity with GLP/GCP/GMP. The individual will be expected to have good laboratory habits and work under GLP regulations in execution and documentation of analytical testing. A B.S. degree and 1+ years of experience is required.
QA Manager – External QA – Job Code 47102101 DE
Will perform QA review and release of contract manufacturing filling and packaging batch records to evaluate compliance with SOPs and cGMPs.
Management responsibilities include tracking contract lot release timelines and resolving issues to meet market and clinical needs. The individual will also be accountable for conducting attribute sampling and inspection on contract packaging lots, assist with GMP training and upkeep of group training records, be a part of new product introductions, and create a contract packaging batch records.
Required:
• BS degree and 5 years experience with quality systems, manufacturing processes, batch review, and/or product release in the pharmaceutical industry
• Must be able to effectively investigate issues in a timely manner, and maintain audit-ready lot release records
• Strong organizational and communication skills
• Experience with statistics and GMP auditing
Scientist/Group Leader, Virology – Job Code 41102101 FS
Responsible for virological and immunological characterization of vaccine-induced antibodies, propagation and characterization of viruses from different HIV subtypes, and generation of high quality data required to support regulatory submission.
Required:
• PhD in Virology, Cell/Molecular Biology, or Immunology and at least 2 years of relevant post-doctorate laboratory experience
• Experience working in a BL2+ facility, especially with HIV is preferred
• Experience with flow cytometry is desirable
• Good leadership and team building skills
• Must possess a strong attention to detail, and have excellent communication skills, as well as the ability to work independently and as part of a team
Quality Assurance, Documentation Manager Job Code 47100401 NW
Responsible for establishing and maintaining documentation systems required to support contract manufacturing and testing operations, technology transfers, and process development activities. Specific activities will include:
• Develop and maintain a filing and storage system for documentation related to contract manufacturing and testing;
• Support technology transfer activities by identifying documentation to be transferred (e.g. test procedures, raw material specifications, batch records, etc.) and facilitate the establishment of that documentation at a contract manufacturer;
• Obtain and/or draft the Standard Operating Procedures (SOPs) and other documentation related to manufacturing required in-house;
• Develop a common format and review and approval process for protocols and final reports;
• Review documentation relating to release of all clinical trail and commercial material;
• Prepare manufacturing related documentation for regulatory submissions;
• Establish and maintain a process to review all errors and deviations in manufacturing method and test results;
• Establish and maintain a process to review any changes made by a contract manufacturer or testing lab to a process, procedure and/or facility; and
• Travel, approximately 10% of the time.
Required: BS/BA degree in life science or equivalent. Minimum 3-5 years of industry experience with a working knowledge of current Good Manufacturing Practices (cGMPs), documentation systems and quality assurance concepts required. Self-starter with strong written and verbal skills are desired. Should possess the ability to lead and/or work as part of a collaborative team.
Molecular Biology RA or Senior RA – Job Code 43100101 DS
We are seeking researchers with experience in Molecular Biology to join a program aimed at producing novel HIV vaccine products.
Responsibilities will involve: Development of engineered vaccine antigen candidates, including construction, expression and characterization. Immunological characterization of antisera raised against them. Genetic and functional characterization of viruses from clinical trial cohorts and using that information in the development of new vaccine products.
This position requires a large amount of hands-on experience in Molecular Biology, specifically plasmid construction, RT-PCR and molecular cloning, automated DNA sequencing and sequence analysis, mammalian cell culture and transfection. Other helpful skills include site-directed mutagenesis, protein characterization and structural analysis, ELISA and other immunological methods, and reporter gene assays. Experience in Virology and/or Immunology is desirable. Familiarity with DNA sequence analysis software, as well as Word and Excel are required.
This individual should have a BS or MS in a relevant field, and at least four years of laboratory experience, preferably in industry. This individual will work as part of a multidisciplinary product development, and will be expected to take responsibility for generating reliable, high quality data. The successful candidate must be self-motivated, and have excellent communication skills, as well as the ability to work independently and as part of a team.
Process Development – Fermentation Research Associate – Job Code 46060401CK,GG
This candidate would be responsible for the design, optimization, validation, and scale-up of CHO cell fermentation processes. The position involves hands on operations of fermentation systems, ranging from 2L-10L reactors. Requires excellent troubleshooting skills and data analysis skills.
Knowledge of pharmaceutical industry manufacturing operations, laboratory and commercial scale instrumentation is necessary. Excellent people skills, demonstrated problem solving ability and effective GMP documentation skills are needed. The successful candidate will be expected to be self-motivated and able to work in collaboration with other groups such as cell culture and protein chemistry groups to achieve project goals.
Requirements: B.S. in an appropriate discipline such as biochemistry, microbiology or chemical engineering degree with a minimum of 3 years of pharmaceutical or biotech company experience.
VaxGen offers full benefits and a competitive salary package. Applicants should send a curriculum vitae or resumé including job code to:
VaxGen, Inc.
Attn: Human Resources
1000 Marina Blvd., Suite 200
Brisbane, CA 94005-1841
or e-mail: jobs@vaxgen.com (text only)
Fax: 650.624.1001
No phone calls please
Please indicate job code in the subject line of your e-mail.