1 день назад
Manufacturing Representative - Night Shift (Oligonucleotide Manufacturing)
32 - 50$
Мэтч & Сопровод
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Описание вакансии
Текст:
TL;DR
Manufacturing Representative - Night Shift (Oligonucleotide Manufacturing): Supporting the commissioning, qualification, and validation of manufacturing equipment while producing oligonucleotide APIs in a GMP-regulated facility with an accent on process scale-up, equipment operation, and compliant documentation. Focus on troubleshooting critical process equipment, resolving manufacturing issues with Engineering, Validation, and Quality teams, and establishing SOPs and training materials for a new facility.
Location: US-CO-Frederick; onsite manufacturing facility. Training follows a day shift schedule of Monday–Friday, 8 am–5 pm, after which the role transitions to a night shift based on business needs.
Salary: $31.92–$49.88 per hour, plus eligibility for bonus, stock, and benefits.
Company
is expanding its oligonucleotide manufacturing capabilities through a new purpose-built facility supporting therapeutic development.
What you will do
- Support commissioning, qualification, and validation of new manufacturing equipment and systems.
- Manufacture oligonucleotide APIs in a GMP-regulated environment.
- Assist with technology transfer and process scale-up from Technical Services to Manufacturing.
- Operate, maintain, calibrate, and troubleshoot laboratory instruments and critical process equipment.
- Write and revise SOPs and other documentation, including CAPAs, deviations, and change controls.
- Collaborate with Engineering, Validation, and Quality teams and help establish best practices and training materials.
Requirements
- Associate’s or bachelor’s degree in a scientific or technical field, or equivalent experience.
- At least 1 year of pharmaceutical or GMP manufacturing experience.
- Strong attention to detail, documentation, math, and troubleshooting skills.
- Ability to follow SOPs and safety protocols and work comfortably with complex equipment.
- Experience in chemical processing, PSM-regulated, clean room, or FDA-regulated manufacturing environments is highly desired.
- Willingness to work the required training day shift and transition to a night shift.
Nice to have
- Familiarity with oligonucleotide synthesis, HPLC, UFDF, and lyophilization.
- Mechanical aptitude and experience with laboratory instruments such as spectrophotometers, conductivity meters, and auto-pipettors.
Culture & Benefits
- Full-time schedule with no specified end date.
- Eligibility for bonus, stock, and benefits.
- Work in a startup manufacturing operation and contribute to training future team members.
- Environment focused on integrity, trust, respect, teamwork, accountability, quality, and speaking up.
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