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Job Runner

 
  • Category: Healthcare
  • Education: Bachelors Degree
  • Employment Length: fulltime
  • Location: Emeryville CA
  • Source: Business
  • Ad #: 15073
 
Via: kellyjobsmnetwork Apply / More Info
 
Full Details

MANUFACTURING ASSOCIATE II-PURIFICATION

LOCATION: Emeryville, CA

6 Month Contract (Possible to Extend)

Duties:

  • Purifies proteins in a regulated FDA licensed & ISO certified facility.
  • Performs cross-functional activities associated with downstream production runs in collaboration with Bulk Fill & QC testing groups.
  • The role may include special projects such as process development & validation activities where scientific research principles are applied.

Purify recombinant proteins to ensure commercial product demands are met:

1. Works as part of the purification team to perform purification, filtration, & centrifugation operations according to standard operating procedures (SOPs).

2. Executes laboratory operations that include dispensing of chemicals, volumetric & gravimetric measurements, making accurate dilutions, & preparing solutions.

3. Performs SAP duties that include cycle counting, reservations, issuing to process orders, & charging of expiring raw materials.

4. Performs equipment maintenance tasks, column packing, & column testing procedures.

5. Ability to multi-task & become proficient at purification & conjugation.

6. Responsible for ordering raw materials & components, as required.

7. Promotes & maintains a safe & well-organized work environment.

Follow regulatory requirements:

1. Adheres to manufacturing & safety procedures, manufacturing operations, current good manufacturing practices (cGMP), & ISO requirements.

Documentation:

1. Executes & reviews batch records & logbooks, which requires legible & concise data entry.

2. Completes all training documentation within a pre-defined timeframe.

Analytical Testing:

1. Analyzes in-process samples & understands how to apply the information to process control & quality monitoring.

2. Operates lab equipment such as pH meters, balances, centrifuges, spectrophotometers, HPLC systems, & densitometers

Required Skills & Abilities:

  1. Works well in a team environment & utilizes project management skills to oversee completion of production lots.
  2. Complies with cGMP & ISO requirements.
  3. Maintains accurate documentation related to manufacturing processes.
  4. Demonstrates leadership skills to train & guide fellow associates in collaboration with team supervisors.
  5. Must have knowledge of protein purification processes.
  6. Experience following & writing SOPs.
  7. Very good verbal & written communication skills.
  8. Proficient with MS Word & Excel.
  9. Able to document & review work accurately; must be well-organized.
  10. Experience with preparation of reagents following manufacturing SOPs.
  11. Delivers quality products & services on time to all customers, both internal & external.
  12. Must be attentive to detail.
  13. Effectively manages time.
  14. Considers how daily manufacturing activities impact product quality.
  15. Monitors processes & products to identify opportunities for continuous improvement.
  16. Experience with project management is desirable.
  17. Knowledge of SAP, Kaizen, & 5S is desirable.
  18. Able to lift & push up to 35 pounds.

Years of Experience:

  • At least 2 years’ of experience with a BA/BS in a GMP environment.
  • Six years of relevant experience can substitute for a degree in the sciences.

Education:

  • BA/BS in the Sciences (Biology, Engineering, or related field)
 
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