11 Oct

Process Engineering Scientist Engineer Associate Jobs Vacancy in Alder Biopharmaceuticals Inc Bothell

Position
Process Engineering Scientist Engineer Associate
Company
Alder Biopharmaceuticals Inc
Location
Bothell WA
Opening
11 Oct, 2018 30+ days ago

Alder Biopharmaceuticals Inc Bothell urgently required following position for Process Engineering Scientist Engineer Associate. Please read this job advertisement carefully before apply. There are some qualifications, experience and skills requirement that the employers require. Does your career history fit these requirements? Ensure you understand the role you are applying for and that it is suited to your skills and qualifications.

Follow the online directions, complete all the necessary fields, and provide all relevant information so your application is submitted correctly. When you click the 'Apply this Job' button (open in new window) you will be taken to the online application form. Here you will be asked to provide personal and contact details, respond to employment-related questions, and show how you meet the key selection criteria.

Process Engineering Scientist Engineer Associate Jobs Vacancy in Alder Biopharmaceuticals Inc Bothell Jobs Details:

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.

Qualifications:
  • PhD in a relevant scientific discipline (such as engineering, chemistry, biochemistry, or analytical chemistry) with 0-2 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.


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