Manufacturing Associate

R&D Partners; Novato (CA); On-site; USD 39,000 - 44,000; Full time

Benefits offered by this job

Medical insurance

401k plan

Employee Assistance Program

Long-term disability

Weekly payroll

Timecard approval

Job summary

R&D Partners in Novato, CA is hiring a Manufacturing Associate to support pharmaceutical client projects on a 12-month contract. The role involves learning biopharmaceutical manufacturing processes, operating equipment, and supporting process optimization.

The schedule runs Wed/Thu–Sat or alternating with 6:00am–7:00pm shifts. Candidates should have a science or engineering degree with biotech experience, be able to lift 25 pounds, work in a team, and adapt to shift-based hours.

Qualifications

• Bachelor’s degree in science or engineering or Biotech certificate with 2+ years in biotech manufacturing or regulated industry.
• Physical exertion including bending, reaching, lifting up to 25 pounds.
• Must be able to work around loud equipment and follow PPE requirements.
• Shift-based work and off-hours as needed.

Responsibilities

• Understand process theory and equipment operation.
• Learn biopharmaceutical manufacturing processes (cell culture, filtration, chromatography, centrifugation, protein purification, formulation).
• Support process optimization initiatives.
• Identify processing issues and contribute solutions.
• Gain experience with automation systems (LIMS, MES, PI, etc.).
• Provide feedback to procedures and help adopt new technologies.
• Write and review process documents.
• Apply cGMP concepts and quality systems (Deviations, CAPAs, Change Requests).
• Collaborate on projects and support new business systems (TrackWise, ERP).
• Assist in tracking department metrics.

Skills

Strong communication

Teamwork

Education

Bachelor’s degree in science or engineering or Biotech certificate with 2+ years of biotech manufacturing experience

Tools

LIMS

MES

PI

TrackWise

ERP

Job description

We are hiring a Manufacturing Associate to assist our pharmaceutical client's project needs. This is a 12-month contract based in Novato, CA. Schedule Alternating Wednesday, Thursday through Saturday 6:00am-7:00pm.

Responsibilities

• 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.).
• 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.
• Understanding of cGMPs as related to Commercial Operations. Ability to utilize Quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
• 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.

Qualifications

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

Pay

• $28.00-$32.20 per hour
• Eligible for shift differential pay and overtime pay

Why Choose R&D Partners?

As an employee, you have access to a comprehensive benefits package including:

• Medical insurance – PPO, HMO & HSA
• 401k plan
• Employee Assistance Program
• Long-term disability
• Weekly payroll
• Online timecard approval

R&D Partners is a global functional service provider and strategic staffing resource specializing in scientific, clinical research & engineering. We provide job opportunities within major pharmaceutical, biopharmaceutical, biotechnology, and medical device companies.

R&D Partners is an equal-opportunity employer.