We’re looking for a Lead Operator - Fill Finish to join a growing startup, an early-stage biotechnology company developing innovative bacteriophage therapies focused on tackling antibiotic-resistant bacterial infections. In this role, you will operate in a cleanroom environment and will be responsible for the formulation of a drug product.
Our client is a growth-stage biotechnology company founded by an award-winning and highly respected emeritus NIH scientist to address the global crisis of antibiotic-resistant bacterial infections. The technology has already been shown to be effective and has received significant attention for several life-saving case studies (including features in TIME magazine, Wash Post, MIT Tech Review, and many others), and was recognized by CB-Insights in 2019 as one of 36 startups with game-changing technology that could change the world.
The company is funded through a combination of venture capital and Federal government (DoD) R&D contracts.
In this role you will:
Act as the group lead for a Fill Finish team operating in a GMP cleanroom environment. This candidate will be responsible for the manufacture and QC check of an injectable biologic drug substance into ready to use vials (finished drug product). Responsibilities will also include scheduling of personnel for fill-finish operations, oversee the management of related inventory supply and maintaining/review of detailed manufacturing batch records.
Additional Major Responsibilities:
Leads processes for the manufacture of the Finished Drug Product under approved standard operating procedures (SOPs).
Adheres to the company Quality Management System (QMS) to maintain highly controlled manufacturing process.
Responsible for training of new personnel on established SOPs and related manufacturing processes.
Composes, edits and maintains SOPs of manufacturing processes
Adheres to current Good Manufacturing Practices (cGMP), Good Documentation Practices (GDP), Biological Safety Level-2 (BSL-2), and strict aseptic technique in all manufacturing/Laboratory processes.
Maintains a clean working environment including participation in regular laboratory cleaning schedule per established cleaning SOPs.
Job requirements:
BS in biology, chemistry, engineering or related field.
2+ years of experience in GMP bioprocessing/manufacturing in cleanroom environments.
Experience operating automated filling instruments is highly desired.
Must be able to lift 40 lbs.
Must be able to stand and work for extended periods of time.
Will require scheduling flexibility to accommodate varying manufacturing schedules. Weekend shifts are also possible.
Experience handling biologics is a plus.
Candidate must have outstanding organizational and communication skills.
Have experience working in a manufacturing team environment.