Process Engineer/Scientist (Drug Product)
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 is currently in late-stage clinical development and, 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 expects to submit a Biologic Application License to the FDA for eptinezumab in early 2019. Alder plans to obtain regulatory approval in the United States for eptinezumab for the treatment of patients with episodic migraine and chronic migraine. Advancing and commercializing eptinezumab in the United States is Alder’s priority however we may be exploring partnership opportunities to commercialize eptinezumab in the rest of the world.
At Alder, transforming the migraine treatment paradigm isn’t just something we say – it’s what we do. It’s our dedication each and every day to work to deliver a drug 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 individual will ensure drug product processes are robust, scalable, well-characterized, and economical for pipeline molecules. The successful candidate will interact with internal product development groups and with Alder's external CMOs/contract labs. Primary responsibilities include supporting commercial manufacturing, experiments supporting deviation closure, data analysis and trending utilizing statistics, and providing reports to enable process validation for drug product. This position will be filled at a level commensurate with experience.
Specific responsibilities will include:
- Design process characterization protocols and lead studies internally / externally to meet launch timelines.
- Communicate to senior management current commercial requirements for laboratory studies supporting process characterization of unit operations and developing acceptance criteria for these studies.
- Drafting of protocols for CRO/CMO studies.
- Author and/or review regulatory sections for investigational new drug applications and marketing authorization regulatory filings.
- Perform on-site troubleshooting during process scale-up (international travel required).
- Interpret analytical results and write technical reports independently.
- Represents and serves as a technical expert for process engineering on one or more internal cross functional project teams and interact with CMO/external project teams to enable successful process validation.
- PhD in a relevant scientific discipline (such as engineering, chemistry, biochemistry, or analytical chemistry) with 2+ years relevant experience or MS/BS with equivalent experience.
- Experience scaling-up drug product and/or packaging, with a working knowledge of GMP requirements and ICH guidelines is required.
- Experience with characterization of drug product formation and fill/finish unit operations (e.g. freeze/thaw, mixing, filtration, and visual inspection)
- The ability to work independently, and to proactively prioritize and accomplish multiple tasks simultaneously is required.
- The candidate should also have demonstrated experience including independent design of protocols and developing acceptance criteria.
- The candidate must be willing to periodically travel to contract manufacturing sites for on-site support.
- Packaging subject matter experience is also desirable for launch activities and commercial support.
Life At Alder: Perks and Benefits
We offer medical, dental and vision insurance, covered at 100% for employees and their dependents, along with flexible spending accounts, life insurance, short- and long-term disability, and opportunities to participate in 401(k) and employee stock option plans.
This is combined with generous vacation time (new employees start with three weeks of vacation/year), three weeks of paid leave following the birth or adoption of a child, and paid holidays and sick leave.
The “Extra” Perks
At Alder, we believe that taking care of one’s self – both physically and mentally – enables our employees to feel their best and do their best work. To that end, we offer on-site yoga two times each week, monthly reimbursement for gym membership, and on-site breakfast options, sandwich bar, ice cream treats, snacks and beverages.