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Careers
Organizational Summary
Bionovo is a drug discovery and development company focused on developing safe and effective drugs for the treatment of unmet needs in women's health and cancer. Our mission is to improve the quality of women's health and defeat life-threatening cancers.
Current Openings
Job Descriptions:
Clinical Research Associate II
Bionovo, Inc. (NASDAQ: BNVI), a publicly traded biopharmaceutical company located in Emeryville, California, is currently seeking a qualified, highly motivated individual for the position of Clinical Research Associate II reporting directly to the Director of Clinical Development.
The company is currently focused on one program in late stage clinical development, targeting large, unmet medical needs. Bionovo is preparing to launch a Phase 3 trial of Menerba for menopausal hot flashes in October 2011. In addition, a number of Phase 1 trials of Menerba are in various stages to further look at the drug's safety and tolerability. The company’s second compound, Bezielle, is ready to enter Phase 2 testing for the treatment of metastatic breast cancer.
The successful candidate will have the skills necessary to thrive in a small company environment, as he/she assists Clinical Research staff in the conduct of clinical trial activities in accordance with Standard Operating Procedures and all applicable regulations governing the conduct of clinical trials. Particularly important skills include intelligence, logical thinking, ability to prioritize, “can-do” attitude, the ability to adapt quickly to changing business conditions, and strong interpersonal and team building skills.
Overall responsibilities for managing the full scope of clinical operations (protocol development to final report, regulatory filing and/or publications) and coordinating cross functional efforts in the administration and progress of a clinical trial(s) in order to achieve study objectives and corporate goals.
ESSENTIAL FUNCTIONS
Essential functions include but are not limited to the following:
• Assist in managing defined aspects of clinical studies at Bionovo to ensure studies are completed on time, within budget and in compliance with SOPs, FDA regulations and ICH/GCP guidelines
• Collect, review for accuracy, and submit essential documents for filing in Trial Master File
• Perform the activities associated with the implementation and monitoring of clinical trials Oversee drug accountability at investigator sites and assist with the projection and management of both clinical and non-clinical supplies
• Assist in the preparation of clinical study reports, annual reports, IND updates, etc.
• Prepare and update study drug forecasts
• Work with Medical Monitor and Director of Clinical Development to select investigative sites, train investigators and investigative site staff, preparation of materials for investigator meetings, clinical supplies
• Maintain study timelines. Identify and communicate study issues that will impact budget, resources and timelines.
• Review and critique CRFs for accuracy and completeness. Oversee data discrepancy management and assists with mapping as needed
• Provide training to internal and external customers as needed Ensure that supportive study documents are completed (e.g., IVRS, specific scripts, non-clinical supply materials)
• Contribute to wider organizational goals and/or activities as assigned.
• Travel up to 40%
Desired Background and Experience:
• BS/BA in Life Science or related discipline; or equivalent experience
• 2-5 years industry experience in drug development;
• Phase 3 experience preferred
Please submit a cover letter, CV, and references to jobs[at]bionovo.com.
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Job Title: Researcher – physico-chemical properties of powders
Location: Emeryville, CA
Responsibilities:
• Investigate physico-chemical properties of powders consisting of plant-derived materials.
• Investigate and assess suitability of published test procedures and develop new test protocols to allow characterizing the physico-chemical properties of powders consisting of plant-derived materials.
• Investigate and characterize extraction of analytes from botanically-derived materials.
• Investigate and characterize the physico-chemical and stability properties of powdered drug substances prepared from botanical raw material.
• Participate in developing company quality standards for raw materials utilized in manufacturing botanically-derived pharmaceutical products.
• Investigate influence of storage conditions on the physico-chemical properties, stability, and processibility of powders consisting of plant-derived materials.
• Participate in developing procedures and protocols for storing botanical raw materials and drug substances prepared with these materials.
• Participate in developing company quality and shelf stability standards for manufactured botanically-derived pharmaceutical products.
• Participate in developing company standard test procedures.
• Participate in project teams and interface routinely with research, process development, quality, regulatory and facilities staff to implement test procedures and quality standards under cGMP for a botanically derived pharmaceutical product candidate that is entering phase 3 clinical testing for a mass market indication.
• Process experimental data, develop and produce research reports.
• Conduct laboratory maintenance (equipment maintenance, calibration, cleaning and related documentation) in accordance to company and regulatory requirements.
Requirements and Qualifications:
• MS or PhD in Physical Chemistry, Chemistry, Chemical Engineering, Material Engineering or related scientific field.
• Demonstrated experience in investigating physico-chemical, mechanical and functional properties of powders.
• Demonstrated experience in investigating and characterizing mass transport phenomena involving powders.
• 3-5 years research experience in relevant fields.
• Demonstrated capabilities to conduct independent research activities.
• Excellent organizational, computer, written and verbal communication skills.
This position is located in Emeryville, California.
Please submit a cover letter, CV, and references to Moshe Rosenberg at mrosenbergy[at]gmail.com.
Bionovo offers a competitive salary and benefits package.
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Job Title: Project Site Manager
Location: Hayward, CA
Description:
Provide critical support services for a new pharmaceutical manufacturing facility.
Position responsibilities encompass three key aspects:
1.) Project Management:
• Create and track program work plans.
• Identify resources needed and tracks individual responsibilities.
• Manage day-to-day operational aspects of a project and scope.
• Review deliverables on an on-going basis and provide continuous feedback to senior management.
• Ensure project documents are complete, current, and stored appropriately.
• Develop, track and report project budget.
2.) Procurement and Supply Chain:
• Select and procure equipment and supplies at the direction of the Project Engineer and other key team leaders.
• Organize, track and oversee routine maintenance services and recurring service contracts.
• Manage supply chain logistics for raw materials and in-process materials, under the direction of the Assistant Director of Procurement and the project executives.
• Manage the warehouse operations as needed.
3.) Site Support:
• Administer on-site EH&S programs.
• Assure compliance for local, environmental and other regulations.
• Other general duties and specific tasks as needed.
Education and General Requirements:
The qualified candidate will have a Bachelors degree or have equivalent training and experience, and at least five (5) years of relevant experience. Relevant experiences would include (but not be limited to): pharmaceutical manufacturing, manufacturing plant logistics, and program management. The qualified candidate should have an understanding of cGMPs and pharmaceutical manufacturing requirements.
Position will require an ability to respond to a very quickly paced and rapidly moving project and production schedule. The candidate should have the ability to independently manage assigned projects and deliver results within expectations, and should be able to prioritize and complete assignments in functional area supporting department objectives and management decisions.
Other General Requirements Include:
• Must be able to exercise judgment within generally well-defined procedures and practices to determine appropriate action.
• Coordinates cross-functional efforts to resolve manufacturing issues in projects.
• Demonstrates the ability to compromise and reach consensus, and resolves conflicts within area of responsibility.
• Coordinate multiple tasks simultaneously.
• Collect, interpret, and/or analyze complex data and information,
Work Environment:
Bionovo is a fast-paced, team-oriented environment, where there are no set boundaries of responsibility. “Other general duties and specific tasks as needed” is a company-wide job description.
• Majority of work time is spent in manufacturing environment, and will require flexibility in scheduling.
• Manufacturing facilities temperatures may be warm in summer months and cool in winter months; dust is present and noise level can be moderate to high.
• Must use PPE as required, which may include hearing protection, appropriate footwear and/or safety glasses.
Interested parties, send cover letter and resume to jobs[at]bionovo.com
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Job Title: Warehouse Manager - Buyer
Location: Hayward, CA
Description:
This position will initially support facility start up including designing, establishing, managing and performing raw materials warehousing, sampling, inventory control and the drafting and implementation of GMP documentation. Once the facility is operational, this position will be responsible for the day-to-day activities of the warehouse, shipping and receiving. Responsible for ensuring the timely flow of all GMP materials throughout the company, interacting closely with Quality Control, Quality Assurance, and Manufacturing and to ensure that all required materials are available for production in a timely manner and in sufficient quantity to avoid production delays. The scope of this position also includes managing the shipment of bulk intermediate for lyophilization, packaging and labeling activities, equipment transport and other service activities as needed.
Also, the position will be responsible for procurement (buying) of supplies and equipment in support of the manufacturing facility, and will have some EH&S responsibilities.
Major Responsibilities:
• Organization, management and movement of all raw, in process and finished goods materials, warehousing and distribution.
• Interface with personnel responsible for planning and scheduling of production requirements. • Plan and manage inventory levels through interaction and collaboration with production, supply chain and marketing for long term production plans and targeted Finish Goods levels.
• Manage and execute daily warehousing operations including staging, cycle count, receiving, storage of materials per SOP, shipping of finished goods and in-direct material.
• Generate and maintain documentation related to the materials function.
• Purchase supplies and equipment in support of the manufacturing facility.
• Prepare and track meaningful metrics and procedures to drive process improvement.
Education and Requirements:
The qualified candidate will have a Bachelors degree or have equivalent training and experience, and at least five (5) years of GMP warehouse experience, with at least two (2) years of supervision, production planning or supply chain management experience. Must have hands on knowledge and substantial experience working with an ERP, to include system implementation. Must have good written skills, and good familiarity with Microsoft Word, Microsoft Excel, and inventory control systems.
This position requires physical demands of lifting up to 25 kilograms and may involve work with hazardous materials. The position will require shift work, including weekends, off hours and holidays as needed. Will require up to 10% domestic and international travel.
The qualified candidate should have excellent communication and interpersonal skills. Must be able to independently manage assigned projects and deliver results within expectations. Completes assignments in functional area supporting department objectives and management decisions. Must be able to exercise judgment within generally well-defined procedures and practices to determine appropriate action. Coordinates cross-functional efforts to resolve manufacturing issues in projects. Demonstrates the ability to compromise and reach consensus, and resolves conflicts within area of responsibility.
Interested parties, send cover letter and resume to jobs[at]bionovo.com
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