Sr Manufacturing Tech

Gilead Sciences•Oceanside, CA

20h

About The Position

The Senior Manufacturing Technician works on the manufacturing floor as part of a cross-functional team to execute and lead processes for viral vector products in a cGMP environment. The role collaborates closely with Manufacturing Science and Technology, Facilities and Engineering, and Quality, while following batch records, SOPs, and cGMP requirements to maintain safe, compliant, right-the-first-time operations. The technician performs and manages inventory transactions, raw-material weighing and cycle counts, buffer preparation, purification, filling, solution formulation, filter integrity testing, and downstream purification. The role also reviews in-process documentation, escalates and communicates floor issues, contributes to operational excellence and continuous improvement, and develops manufacturing documents. Additional responsibilities include serving as a qualified trainer backup, mentoring junior staff, leading tier huddles as needed, and acting as a delegate for supervisors or managers in cross-functional meetings. The position requires flexibility to work off-shift hours and weekends, and to provide on-call support as required.

Requirements

One of the following education and experience combinations: a master’s degree and at least 2 years of manufacturing or engineering experience in biotech/pharma; a bachelor’s degree and at least 4 years; an associate degree and at least 5 years; or a high school degree and at least 6 years.
Excellent communication skills and ability to collaborate across all levels.
Ability to work effectively in an inclusive, cross-functional, team-based environment.
Ability to work off-shift hours and weekends.
Ability to lift 40 pounds repeatedly and stand for hours at a time.
Ability to provide on-call support as required.

Nice To Haves

At least 6 years of experience with a bachelor’s degree in biology or a related scientific discipline, or an equivalent combination of experience and education.
Prior experience with biopharmaceutical, cell, or gene therapy manufacturing across downstream and filling operations.
Knowledge and experience with single-use systems, including chromatography, UFDF, and single-use mixers.
Experience with automation platforms and electronic batch records.
Knowledge of current Code of Federal Regulations and cGMP requirements.
Strong skills in Microsoft Word, Excel, and data analysis.
Comfort working in a fast-paced environment with minimal direction and adjusting workload as priorities change.
Self-motivation and willingness to accept temporary responsibilities outside the initial job description.
Excellent interpersonal, verbal, and written communication skills.
Willingness to think creatively and work in an evolving environment.

Responsibilities

Work as part of a team to execute and lead manufacturing processes on the floor in collaboration with MSAT, Facilities and Engineering, and Quality.
Follow batch records, SOPs, and cGMP regulations to ensure safe and compliant manufacturing operations.
Ensure right-the-first-time performance of process steps and help drive a safety-first culture.
Perform and manage electronic inventory transactions using MES and EBS, including raw-material weighing and cycle counts.
Perform, troubleshoot, and manage moderately complex issues during buffer preparation, purification, and filling unit operations for viral vector products.
Manage tasks related to solution formulation and filter integrity testing.
Execute downstream purification processes.
Escalate floor issues for triage and communicate status updates and follow-ups.
Review and sign off in-process cGMP documentation for completeness, accuracy, and compliance.
Participate in and manage operational excellence initiatives, including 5S, Kaizen, lean manufacturing, and continuous improvement.
Develop SOPs, Manufacturing Production Records, and other process documents, including minor deviations and CAPAs as needed.
Act as a delegate for supervisors and managers during cross-functional team meetings.
Manage and write shift notes for all unit operations.
Lead operational tier huddles as needed.
Manage and serve as a backup qualified trainer for all unit operations.
Mentor junior staff with limited task-management responsibility.
Perform additional duties as assigned; duties may be delegated to qualified deputies as needed.