Manufacturing Associate/Sr. Manufacturing Associate (Night Shift)
BioMarin Pharmaceutical Inc.
7 months ago
On-site
Novato, CA
Operations
Manufacturing Associate / Sr. Manufacturing Associate
Responsibilities:
- Understand process theory and equipment operation.
- Learn and operate biopharmaceutical manufacturing processes: cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification, and formulation of bulk drug substance (with scientific, compliance, and technical understanding).
- Support process optimization initiatives.
- Identify and elevate processing issues and support solutions.
- Demonstrated experience with automation systems (LIMS, MES, PI, etc.).
- Technical documentation: provide feedback/suggest changes to operational procedures; assist in incorporating new technologies, practices, and standards; write and review process documents.
- Quality and compliance: understand cGMPs related to Clinical and/or Commercial Operations; use quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
- Business: participate on projects and contribute to outcomes; learn and support business systems (TrackWise, ERP, etc.); support trending of defined department metrics.
- Other duties as assigned.
Required Skills / Experience:
- Associate: 0–2 years manufacturing experience.
- Read and understand SOPs & BRs.
- Multi-task when needed.
- Run high-end equipment and machinery.
- Work safely in a GMP laboratory.
- Sr. Associate: 2–4 years manufacturing experience.
Desired Skills:
- 1–2 years of experience in a GMP and manufacturing field.
Education:
- BA/BS preferred (not required); Biotech certificate.
Equipment:
- Chromatography skids, TFF skids, buffer tanks, lab washers, autoclaves.
Shift / Work Location:
- Onsite only. Back half night shift: Wed–Fri/Sat 6pm–7am; alternating Saturday.
Work Environment / Physical Demands:
- Strenuous, repetitive work; bending, reaching, climbing stairs/ladders, kneeling, making equipment connections.
- Lift/dispense/push/pull average up to 25 lbs.
- PPE required; may require work around loud equipment and off-hours.
Travel Required:
- NA
Responsibilities:
- Understand process theory and equipment operation.
- Learn and operate biopharmaceutical manufacturing processes: cell culture, cell production and protein harvest, depth filtration, tangential flow filtration, column chromatography, protein purification, and formulation of bulk drug substance (with scientific, compliance, and technical understanding).
- Support process optimization initiatives.
- Identify and elevate processing issues and support solutions.
- Demonstrated experience with automation systems (LIMS, MES, PI, etc.).
- Technical documentation: provide feedback/suggest changes to operational procedures; assist in incorporating new technologies, practices, and standards; write and review process documents.
- Quality and compliance: understand cGMPs related to Clinical and/or Commercial Operations; use quality systems (Deviations, CAPAs, Change Requests, Action/Alert Reports, etc.).
- Business: participate on projects and contribute to outcomes; learn and support business systems (TrackWise, ERP, etc.); support trending of defined department metrics.
- Other duties as assigned.
Required Skills / Experience:
- Associate: 0–2 years manufacturing experience.
- Read and understand SOPs & BRs.
- Multi-task when needed.
- Run high-end equipment and machinery.
- Work safely in a GMP laboratory.
- Sr. Associate: 2–4 years manufacturing experience.
Desired Skills:
- 1–2 years of experience in a GMP and manufacturing field.
Education:
- BA/BS preferred (not required); Biotech certificate.
Equipment:
- Chromatography skids, TFF skids, buffer tanks, lab washers, autoclaves.
Shift / Work Location:
- Onsite only. Back half night shift: Wed–Fri/Sat 6pm–7am; alternating Saturday.
Work Environment / Physical Demands:
- Strenuous, repetitive work; bending, reaching, climbing stairs/ladders, kneeling, making equipment connections.
- Lift/dispense/push/pull average up to 25 lbs.
- PPE required; may require work around loud equipment and off-hours.
Travel Required:
- NA