Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on transforming the migraine treatment paradigm through the discovery, development and commercialization of novel therapeutic antibodies. Alder's lead product candidate, eptinezumab, is a pivotal-stage monoclonal antibody (mAb) that inhibits calcitonin gene-related peptide (CGRP). Eptinezumab, if approved, will be the first-to-market infusion therapy for migraine prevention. Alder is also developing ALD1910, a preclinical mAb that inhibits pituitary adenylate cyclase-activating polypeptide-38 (PACAP-38) for migraine prevention.
Alder submitted a Biologic Application License to the FDA for eptinezumab in February 2019 and plans to obtain regulatory approval in the United States for eptinezumab for the prevention of migraines for patients that suffer with episodic migraine and chronic migraine. Advancing and commercializing eptinezumab in the United States is Alder's priority however we are exploring partnership opportunities to commercialize eptinezumab outside of the United States.
Alder's mission to is to forever change migraine treatment and give patients their lives back. This isn't just something we say it's what we do. It's our dedication each and every day to working to deliver drugs that can significantly improve the lives of those highly impacted by migraine. We do it for our spouses, our cousins, our friends, our co-workers, and the countless others suffering from migraine. For us, it's personal.
Alder Biopharmaceuticals is seeking a highly motivated individual to join the Pharmaceutical Operations Process Engineering department. This position will be filled at a level commensurate with experience. This individual will ensure processes are robust, scalable, well characterized, and economical for commercial manufacturing. The successful candidate will interact with internal product development groups and with Alder's network of external CMOs/contract labs. Primary responsibilities may include designing process characterization studies, analyzing data using statistical analysis, and authoring reports to enable process validation for downstream processes.
Specific responsibilities will include:
Write protocols and reports to meet commercialization timelines
Generate and implement design of experiments with subsequent statistical analysis of data
Author regulatory sections for marketing authorization regulatory filings
Perform on-site troubleshooting during process scale-up (international travel may be required).
Interpret analytical results and write technical reports used as primary references for regulatory filings
Represent process development on one or more internal project teams and also on CMO/external project teams to enable successful process validation
Requires a PhD in a relevant scientific discipline (such as engineering, chemistry, biochemistry or analytical chemistry) and a minimum 4 years relevant experience, or an equivalent combination of education and experience.
Experience commercializing and scaling-up purification unit operations, with an excellent working knowledge of GMP requirements, FDA and ICH guidelines, is required.
In-depth understanding of unit operations used for downstream processing of monoclonal antibodies.
Demonstrated experience with commercializing process development efforts, including independent design of protocols and developing acceptance criteria. Authoring of regulatory filings is a plus.
Knowledge of statistical process control concepts is desired.
Able to travel 15-20% of time to contract manufacturing sites.
Location: Bothell, WA headquarters
Alder Biopharmaceuticals, Inc.