Just-Evotec⠀Biologics⠀is seeking⠀a highly⠀motivated⠀Cell⠀Culture⠀Manufacturing⠀Associate⠀that⠀desires a⠀significant⠀opportunity⠀to improve⠀worldwide⠀access to⠀biotherapeutics.⠀This team⠀member⠀will be⠀responsible⠀for the⠀commercial⠀manufacturing⠀of⠀mammalian⠀cell-based⠀biotherapeutics⠀under cGMP⠀conditions.⠀Manufacturing⠀Associates⠀are⠀expected⠀to execute⠀process⠀recipes,⠀monitor⠀equipment⠀and⠀processes,⠀perform⠀basic⠀tasks,⠀including⠀sampling,⠀and⠀routine⠀maintenance⠀of lab⠀equipment.⠀Associates⠀will also⠀assist in⠀media and⠀buffer⠀compounding.⠀The staff⠀member is⠀expected⠀to comply⠀and follow⠀written⠀procedures⠀for safety⠀requirements,⠀cGMP⠀Practices,⠀Standard⠀Operating⠀Procedures,⠀and⠀manufacturing⠀documentation.
Must⠀be willing⠀to work⠀either the⠀second⠀(swing) or⠀third⠀(night)⠀shifts as⠀required⠀by⠀production⠀schedule.
Responsibilities:
- Perform⠀and⠀monitor⠀critical⠀processes⠀(i.e., SUB⠀batch,⠀inoculations,⠀perfusion,⠀and⠀harvest⠀operations)
- Supporting⠀the⠀introduction⠀of new⠀products⠀and⠀technologies⠀into the⠀facility
- Initiating⠀non-conformances⠀(NC)
- Execution⠀of⠀Electronic⠀Batch⠀Records⠀(EBR)⠀using⠀Manufacturing⠀Execution⠀System⠀(MES)
- Draft⠀and revise⠀Manufacturing⠀Procedures⠀and⠀Standard⠀Operating⠀Procedures,⠀as⠀necessary
- Support⠀operations⠀of⠀glasswasher⠀and⠀autoclave
- Perform⠀other⠀duties as⠀assigned
Educational Requirements:
- Bachelor’s⠀degree in⠀Science or⠀Engineering;⠀or
- Associate’s⠀degree in⠀science-related⠀area and⠀relevant⠀experience;⠀or
- High⠀school⠀diploma or⠀GED and 5⠀or more⠀years of⠀relevant⠀experience.
Qualification Requirements:
- Candidate⠀must⠀possess⠀strong⠀focus on⠀quality⠀and⠀attention⠀to⠀detail
- Possess⠀effective⠀task/time⠀management⠀organizational⠀skills
- Capacity⠀to develop⠀solutions⠀to⠀technical⠀issues of⠀moderate⠀scope
- Ability⠀to⠀organize,⠀analyze/interpret,⠀and⠀effectively⠀communicate⠀individual⠀results
- Motivated,⠀self-starter⠀with⠀strong⠀mechanical⠀aptitude
- Good⠀interpersonal,⠀team, and⠀communication⠀skills are⠀a⠀must
- Excellent⠀oral and⠀written⠀communication⠀skills