Manufacturing Associate

TalentBurst, an Inc 5000 company; Novato (CA); On-site; USD 60,000 - 80,000; Full time

Job summary

A leading biotechnology firm in California is seeking skilled individuals for their biopharmaceutical manufacturing team. This role requires understanding process theory and equipment operation, as well as strong communication skills. Candidates should hold a Bachelor's degree in a science-related field or equivalent experience. Responsibilities include supporting operational procedures, participating in projects, and working in a team environment. The position demands flexibility in a physically demanding work environment, including alternating shifts.

Qualifications

• Understanding of process theory and equipment operation.
• Ability to learn biopharmaceutical manufacturing processes.
• Knowledge of cGMPs related to Commercial Operations.

Responsibilities

• Provide feedback and/or suggested changes to operational procedures.
• Support projects and contribute to outcomes.
• Participate in new business systems learning.

Skills

Strong communication skills—verbal and written

Ability to work in a team environment

Good conflict resolution and collaboration

Displays good initiative to identify areas for improvement

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

Job description

Shift: Shift is alternating Saturdays, Sunday-Tuesday (6pm to 7am)

Job Description

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, centrifugation, protein purification, and formulation of bulk drug substance. Supports initiatives for process optimization. Identifies and elevates processing issues and supports solutions. Gains 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 may be 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'