Manufacturing - (CW) Manufacturing Associate

Creative Solutions Services, LLC; Novato (CA); On-site; USD 65,000 - 85,000; Full time

Job summary

Creative Solutions Services, LLC is seeking a Manufacturing Associate to support biopharmaceutical production processes at our Novato, CA facility. The role involves learning mammalian cell culture, filtration, chromatography, and formulation, while adhering to cGMP and quality systems.

Responsibilities include documenting procedures, supporting process optimization, and contributing to project outcomes. Requires ability to work shift-based schedules and lift items up to 25 pounds, with PPE

Qualifications

• Requires a Bachelor’s degree in science or engineering or Biotech certificate with 2 years of experience in biotech manufacturing or other regulated industry.
• Understanding of cGMPs in Commercial Operations is preferred.
• Experience with process documentation and operating procedures is desirable.

Responsibilities

• Understand and learn biopharmaceutical manufacturing processes including cell culture, filtration, chromatography, centrifugation, and formulation.
• Support process optimization and identify processing issues, contributing solutions.
• Draft and review operational procedures; incorporate new technologies and standards.
• Support tracking of department metrics and learning new business systems (ERP, TrackWise, etc.).
• Work in a physically demanding environment with repetitive tasks and use of PPE.

Skills

Strong communication

Team collaboration

Initiative

Education

Bachelor's or higher in science/engineering

Biotech certificate with 2+ years experience

Tools

LIMS

MES

TrackWise

ERP

PI

Job description

Job Title: Manufacturing - (CW) Manufacturing Associate

Duration: 12 Months (Possibility of extension)

Location: Novato CA

Shift Schedule front-half nights: alternating Sat and Sun-Tues 1800-0700***

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, centrifugation, protein purification, and formulation of bulk drug substance. Support initiatives for process optimization. Identify and elevate processing issues and support solutions. 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 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

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