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Fermentation Development Engineer     Alder Biopharmaceuticals is seeking a highly motivated individual to join our Fermentation Process Development group. We are specifically seeking an energetic, creative individual who enjoys challenges in fermentation development involving different fermentation scales, and development of processes that can be readily scaled-up . This position reports to the Director of Fermentation and the individual will perform hands-on operations for the development of yeast based fermentation and harvest processes for the production of therapeutic monoclonal antibodies. Daily activities will include design and preparation of experiments, operation and trouble shooting of fermentors and associated equipment, in addition to extensive data documentation of all steps. Qualifications: BS or MS degree in biochemical engineering with 3+ years of relevant hands-on experience in microbial fermentation operations. Candidate should be very well versed in the operation of microbial fermentors, shake flasks, control systems and support equipment (including operation, maintenance and trouble shooting). Due to the nature of this position the candidate from time to time will be required to lift heavy objects (up to 30lbs) from time to time. Flexibility in working schedule with occasional evening and weekend working hours will be required to accommodate experimental needs. Also required are software skills in MS Word, Excel, Powerpoint, and databases. Skills that are highly desirable for this position include: Experience with fermentation process scale-up/scale-down, technology transfer, and familiarity with analytical techniques necessary for monitoring. Fermentation medium and process design experience. Strong technical aptitude in heat transfer, kinetics, thermodynamics and mass transfer. Experience in rational and statistical design of experiments related to fermentation media optimization and process improvement. Knowledge of process control and instrumentation, Boolean Logic and the ability to write process control statements. Prior experience in aseptic technique, development of fermentation parameters, media screening and optimization, feeding strategies and primary recovery of microbial processes. Knowledge of GLP/GMP practices. Please send your cover letter and resume to hr@alderbio.com. When applying for this position, please reference job code P11-03 and let us know how you heard about the opportunity.

Drug Safety Specialist     The Drug Safety Specialist will provide technical and process-related support to clinical drug safety management, ensuring compliance with relevant regulations and Standard Operating Procedures (SOPs). This newly created position will be responsible for the following: Triage of incoming reports for completeness, legibility and validity, including initiation of requests for follow-up as needed. Initial data entry of case reports into Alder safety database / tracking system. Assessment of case reports for seriousness, causality and expectedness. Assist in meeting Alder requirements for communication and data sharing with partners. Scheduling and chairing monthly Safety meetings, including recording and distributing minutes. Participate in project meetings / investigator meetings / project specific training sessions. Creation and maintenance of project-specific working files, case report files and project central files. Tracking trial-related documents, regulatory submissions and safety reports. Reconciliation of safety and clinical databases, including obtaining information from eCRFs and reconciliation of this data with the SAE cases. Creation of monthly Safety metrics. Assist with additional Drug Safety activities as required. Qualifications: Qualified candidates will have a minimum of 3 years Drug Safety experience in the biopharmaceutical setting. Degree in Nursing (RN, BSN), or other health-related field, or equivalent qualifications, sufficient for gaining extensive experience in medical terminology.. Clear understanding of drug safety / drug development process is required. Research experience in a clinical setting preferred but not required.?The successful candidate will have excellent interpersonal skills and will communicate effectively with team members within the company as well as with external contacts. Strong software skills are also required, including database and presentation software. To apply, please send resume and cover letter to hr@alderbio.com. Please reference job posting #C11-04 and let us know how you heard about this opportunity.

Head of Bioanalytical     Alder Biopharmaceuticals is seeking an experienced, detail-oriented Scientist to lead, develop, perform and manage bioassay activities related to pre-clinical and clinical aspects of therapeutic monoclonal antibody drug development. This individual will be responsible for designing, developing, qualifying/validating and managing all bioassays related to pre-clinical, tox, GMP lot release of bulk and finished drug, clinical end point, immunogenicity, pharmacokinetics and pharmacodynamics. Principal duties include: hands-on development of cell-based, ELISA and Flow Cytometry-based bioassays, technology transfer of in-house developed methods to external vendors, providing oversight and managing all aspects of technical, scientific and GLP compliance quality-related issues. Qualifications: Requirements include a minimum of 5 years experience in bioassay development and execution in a similar position with a successful record of managing outside vendors to ensure regulatory compliance that support clinical activities. Experience in Mesoscale Device technology, ELISA methods and cell-based assay techniques necessary to support antibody drug development are required. Application of these techniques to pre-clinical (in-vivo/in-vitro), PK/TK and clinical assay activities is preferred. A detailed understanding of current GLP/GMP practices, safety and regulatory issues is a must. Experience hiring and managing scientific staff is required. This position requires excellent written and interpersonal communication skills as well as the ability to function in a fast-paced, team-oriented environment. Please send your cover letter and resume to hr@alderbio.com. When applying for this position, please reference job code R11-07 and let us know how you heard about the opportunity.

Clinical Trial Assistant      The Clinical Trial Assistant will provide Clinical administrative support, Master File maintenance, for clinical development functions. This position also provides support to clinical development teams by reviewing vendor invoices for accuracy against budget, tracking vendor payments and taking meeting minutes during project team meetings. Administrative Support: • Assist with preparing and editing, tracking, and routing clinical development documents if requested, for example clinical protocols, informed consents. Assist with production of regulatory submissions. • Assists with development and production of study materials, essential documents, presentations, reports, submissions, articles, and other materials. Prepare clinical study conduct binders, track and file routine clinical study documents, either generated internally by Alder or received from CROs, including meeting agendas, minutes, status or patient trackers, patient screening logs and other documents as appropriate. Prepare and track courier packages. • Review vendor invoices for accuracy against budget • Liaise with Finance to ensure payments are made and tracked • Assists with travel when necessary • Assists in preparation for regulatory audits or partnering discussion. • Performs other duties as required to interface with Clinical Research Organizations and study vendors to ensure successful trial conduct. • Other administrative support as required. Master File Maintenance and Clinical Document Control: • Archive and organize clinical trial master file documents, including clinical study site documents, email correspondence, training materials, and other study documents. Generate filing indexes and maintains currents lists of correspondence. Participate in the development of Alder’s clinical trial master filing structure; create physical and electronic filing structures; print, prepare, file, archive, and track paper and electronic documents according to the master file structure. Increasing familiarity with documents is expected with increasing ability to take on more independent identification and appropriate handing of master file documents. Appropriate version and document tracking is required. • Clinical development documents include study conduct documents (e.g. protocols, patient consents, CRFs, site qualification and IMP release documents, conduct plans, study status documents, regulatory and ethics submissions, etc.), financial information, clinical copies of clinical site and vendor contracts, correspondence, study status documents, and other study related documents. • Provide appropriate administrative support, version control, and document tracking for SOPs, other documents maintained under Clinical Control. Qualifications: Minimum of 2 years experience in Clinical Operations or similar department. Bachelor’s degree in a relevant field is preferred. We are looking for a self-motivated and highly flexible individual who is able to manage multiple tasks and priorities within a fast-paced office environment. Must be expert at using Microsoft Word, Excel, and Power Point. Ability to multi-task, excellent communication skills and attention to detail are all key for this role. To apply, please send resume and cover letter to hr@alderbio.com. Please reference job posting #C11-06 and let us know how you heard about this opportunity.