Manufacturing Associate

Intelliswift - An LTTS Company; Novato (CA); On-site; USD 60,000 - 90,000; Full time

Job summary

Intelliswift - An LTTS Company is seeking a Biopharma Manufacturing Process Associate to learn and support manufacturing operations. The role involves understanding mammalian cell culture, filtration, chromatography, centrifugation, and formulation, with a focus on process optimization and quality system usage.

The candidate will contribute to documentation, procedures, and new technology adoption while aligning with cGMPs and project outcomes.

Qualifications

• Bachelor's degree in science or engineering required.
• Associate's degree or biotech certificate with 2+ years in biotech manufacturing or regulated industry.
• Strong communication and teamwork skills required.

Responsibilities

• Understand and learn biopharmaceutical manufacturing processes (cell culture, filtration, chromatography, centrifugation, formulation).
• Support process optimization and issue elevation; assist in automation systems (LIMS, MES, PI).
• Assist in writing/modifying procedures and complying with cGMPs and quality systems.
• Contribute to projects, track department metrics, and learn new business systems (TrackWise, ERP).

Skills

Strong communication

Team collaboration

Initiative for improvement

Education

Bachelor's degree in science or engineering

Associate's degree or biotech certificate with 2+ years experience

Job description

Work Schedules: Schedule is alternating Saturdays /Sundays to Tuesdays from 6pm to 7 am.

Position Summary

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.

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

Equal Employment Opportunity Statement

Intelliswift celebrates a diverse and inclusive workforce. We offer equal employment opportunities to all applicants and employees. All qualified applicants will be considered regardless of race, color, sex, gender identity, gender expressions, religion, age, national origin or ancestry, citizenship, physical or mental disability, medical condition, family care status, marital status, domestic partner status, sexual orientation, genetic information, military or veteran status, or any other protected basis under the law.

Americans with Disabilities Act (ADA)

If you require a reasonable accommodation in completing this application, interviewing, completing any pre-employment testing, or otherwise participating in the employee selection process, please contact Intelliswift Human Resources Department

Other Employment Statements

Intelliswift participates in the E-Verify program.