QC Associate

 

Client/Job Title: Alder Biopharmaceuticals QC Associate

Order Classification: A

Lead: Kathy

GM/Week: $400

Total GM: $9100

Hiring Manager (subs to): Sandi Gray and Pooja Aggarwal

 

CLIENT TIMELINE/EXPECTIONS:

                Subs By: 8/2

                Interviews: Week of 8/5

                Interview Feedback: ASAP

                Start: ASAP

 

SUBMISSION/PACKET REQUIREMENTS: Normal Sub, need references and education verification as well before an offer comes through 

 

Client Information/Pitch: Alder filed for their BLA and now is looking into new delivery methods and markets for their drug!

Why Is This Position Open/Order Description? they are looking at different delivery methods for their drug (currently microbial, going to mammalian). They are manufacturing clinical products for research to determine safety and efficacy

Must Haves: GMP, QC expeirence with method validation, method transfer, report/protocol writing

Preferred Skills: support for clinical products

Competition/Where are they at with the search? Challenges? Just out to us!

Hours/Week: 40

Shift: M-F Days, 

Duration (Contracted temp to hire hours?): 9 month contract

Pay Rate: $28-$36/hr

Mark Up: 65%

 

 

SCOPE

The general scope is  to support analytical method transfer activities for a clinical project to establish 20 methods prior to engineering and clinical runs.  Our QC function is unique in that we don’t have onsite QC labs, so this position interacts with remote testing facilities.   The duties include:

 

  • Coordinating/reviewing data related to method set-up, qualification and pre-validation
  • Critical reagent evaluations for ALD4031 test methods,
  • Supporting efforts related to reference standard generation/qualification and campaign preparation

 

EXPERIENCE

3+ years of experience in method validation, method transfer, report and protocol writing

 

LENGTH OF ASSIGNMENT

We estimate a minimum of 9 months for this project, and while it’s focused on a clinical project, there may also be some work related to our upcoming commercial product. 

 

RATE

Let’s target $28 – $36 per hour, though for the right fit we can look at something higher

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