Manufacturing Associate

Job Description

Industry: Pharmaceuticals

Title: Manufacturing Associate

Location: Novato, CA (100% onsite)

Duration : 12 Months With Possible Extension

Shift and the pay rate:

1st Shift: 7 a.m. to 3 p.m.: $28/hr

2nd Shift: 3 p.m. to 11 p.m.: $30/hr

3rd Shift: 11 p.m. to 7 a.m.: $32/hr

Job Summary:

We are seeking a detail-oriented and proactive Manufacturing Associate with strong knowledge of biopharmaceutical manufacturing processes and a passion for process optimization.

Key Responsibilities:

Process Knowledge:

• Understand and apply process theory and equipment operation in biopharmaceutical manufacturing.
• Learn and support key manufacturing processes including mammalian cell culture, depth filtration, tangential flow filtration, column chromatography, protein purification, and bulk drug substance formulation.
• Support continuous process optimization initiatives.
• Identify process-related issues and collaborate on corrective actions.
• Gain proficiency in automation systems such as LIMS, MES, and PI.

Technical Documentation:

• Review and provide feedback or suggested revisions to operational procedures.
• Assist in integrating new technologies, practices, and industry standards into process documentation.
• Write and review process documents to ensure clarity, accuracy, and compliance.

Quality and Compliance:

• Maintain thorough understanding of current Good Manufacturing Practices (cGMPs) relevant to commercial operations.
• Utilize quality management systems effectively, including handling deviations, CAPAs, change requests, and action/alert reports.

Business Support:

• Participate actively in project teams and contribute toward successful outcomes.
• Learn and support new business systems such as TrackWise and ERP platforms.
• Support the trending and analysis of department performance metrics.

Required Skills:

• Strong communication skills, both verbal and written.
• Proficient computer literacy and typing skills.
• Excellent documentation skills with clear, legible handwriting.
• Ability to work collaboratively in cross-functional teams.
• Detail-oriented with strong problem-solving capabilities.

Education and Experience:

• Bachelor's degree from a 4-year university OR
• Minimum 2 years of relevant experience in biopharmaceutical manufacturing or a related field
• Open to recent grads with a degree in Scientific discipline .