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Manufacturing Associate

Marin Metro Area, CA

Posted: 08/09/2019 Job Type: Scientific Job Number: JN -082019-25406

DUTIES:

Process knowledge:

Understanding of process theory and equipment operation

Ability to learn biopharmaceutical manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification and formulation of bulk drug substance

Support initiatives for process optimization

Identify and elevate processing issues and support solutions

Demonstrated proficiency Gain experience with automation systems (LIMS, MES, PI, etc.)

Technical documentation:

Provide feedback and/or suggested changes to operational procedures

Assist in the incorporation of new technologies, practices and standards into procedures

Capable of writing and reviewing process documents

Quality and compliance:

Understanding of cGMPs as related to Commercial Operations

Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.)

Business:

Ability to participate on projects and contribute to outcomes

Capability to learn and support new business systems (Track wise, ERP, etc.)

Support trending of defined department metrics

WORK ENVIRONMENT/PHYSICAL DEMANDS

Consists of strenuous, repetitive work. The following list of physical movements maybe used on a daily basis: bending, reaching, climbing stairs and ladders, kneeling and making numerous equipment connections using hands.

Independently have the ability to regularly lift, dispense, push and/or pull items with an average weight of 25 pounds.

May require work around loud equipment.

The use of personal protective equipment will be required.

Requires various shift based work and off hours


SKILLS:

Strong communication skills verbal and written

Ability to work in a team environment which includes good conflict resolution and collaboration

Displays good initiative to identify areas for improvement and implement solutions

Education:

Bachelor s degree in science related area or engineering

Associate s degree in science related area or Biotech certificate with 2+ years of experience in a biotech manufacturing environment or other regulated industry

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