Rocket⠀Pharma is⠀a fully⠀integrated,⠀clinical-stage⠀company⠀advancing⠀gene⠀therapies⠀with⠀curative⠀potential⠀for⠀multiple⠀rare⠀childhood⠀diseases.⠀Rocket⠀places⠀enormous⠀value on⠀people and⠀considers⠀team⠀member⠀progress⠀and⠀well-being⠀to be as⠀important⠀as the⠀progress⠀of its⠀pipeline.⠀We are⠀looking⠀for⠀hands-on⠀team⠀players⠀who enjoy⠀collaborating⠀with⠀colleagues.⠀We share a⠀passion⠀for⠀seeking⠀gene⠀therapy⠀cures for⠀devastating⠀diseases⠀and making⠀a⠀difference⠀for⠀patients.⠀This is an⠀opportunity⠀to become⠀an⠀integral⠀part of a⠀small,⠀highly⠀productive⠀team and⠀to help⠀grow an⠀entrepreneurial,⠀scientifically⠀driven⠀organization⠀that is⠀increasingly⠀recognized⠀as a⠀leading⠀biotechnology⠀innovator.⠀In⠀addition⠀to a⠀competitive⠀compensation⠀package⠀featuring⠀a generous⠀401K match⠀and stock⠀options,⠀the⠀position⠀includes⠀excellent⠀health⠀benefits.
Position⠀Summary:
As⠀a Clinical⠀Manufacturing⠀Associate,⠀you will⠀be part of⠀a team⠀responsible⠀for the⠀start-up⠀of a⠀cleanroom⠀facility⠀and the⠀cGMP⠀manufacture⠀of viral⠀vector⠀therapies⠀for use in⠀clinical⠀trials.⠀Additional⠀responsibilities⠀include⠀set-up,⠀operation,⠀and⠀cleaning⠀of⠀equipment,⠀equipment,⠀and⠀process⠀monitoring⠀and⠀troubleshooting,⠀receiving⠀materials⠀and⠀supplies⠀from the⠀warehouse,⠀maintaining⠀supply⠀inventories,⠀creating⠀technical⠀documents,⠀and⠀maintaining⠀cleanrooms⠀and⠀equipment⠀in an⠀inspection-ready⠀state.
The⠀ideal⠀candidate⠀will also⠀have a⠀strong⠀passion⠀and⠀curiosity⠀for⠀science⠀and gene⠀therapy⠀with the⠀desire to⠀contribute⠀individually⠀and⠀collectively⠀in a⠀dynamic,⠀fast-paced⠀environment.
Responsibilities:
- Perform⠀hands-on⠀process⠀operations⠀as⠀directed⠀to⠀manufacture⠀viral⠀vector⠀therapies;
- Work⠀on⠀projects⠀and⠀assignments⠀that⠀require⠀independent⠀action and⠀initiative,⠀and direct⠀communication⠀and⠀collaboration⠀with⠀diverse⠀groups;
- Request,⠀receive,⠀process⠀and store⠀process⠀materials⠀and⠀supplies⠀through⠀direct⠀communication⠀and⠀coordination⠀with⠀Materials⠀Management/Warehouse⠀personnel;
- Maintain⠀process⠀equipment⠀and⠀manufacturing⠀areas in a⠀safe and⠀compliant⠀readiness⠀state;⠀observes⠀and⠀follows⠀all⠀safety,⠀regulatory,⠀legal and⠀compliance⠀requirements;
- Author⠀Standard⠀Operating⠀Procedures⠀and other⠀technical⠀documents⠀with⠀minimal⠀supervision;
- Follow⠀all⠀Standard⠀Operating⠀Procedures⠀and⠀completes⠀all batch⠀documentation⠀including⠀Batch⠀Records,⠀Forms,⠀logbooks,⠀Sample⠀Requests⠀and Test⠀Results;
- Troubleshoot⠀problems;⠀proactively⠀assess⠀options⠀and impact⠀and⠀communicate⠀to⠀appropriate⠀decision⠀makers
Qualifications:
- B.A./B.S.⠀in Life⠀Science,⠀Biotechnology,⠀ChemE, or⠀similar⠀relevant⠀field with⠀0 to 2⠀years’⠀experience⠀in⠀clinical⠀manufacturing⠀or High⠀School⠀Diploma⠀with 2+⠀years’⠀experience;
- Understanding⠀of basic⠀mammalian/microbial⠀cell⠀culture⠀techniques⠀and⠀principles,⠀filtration⠀principles,⠀purification/chromatography⠀principles⠀and good⠀aseptic⠀techniques;
- Execute⠀production⠀of⠀clinical⠀supplies⠀based on⠀established⠀procedures⠀and⠀protocols⠀and⠀implements⠀improvements⠀with⠀minimal⠀supervision;
- May⠀be⠀required⠀to work⠀off-shift⠀hours:⠀early⠀mornings,⠀late⠀evenings/nights,⠀and⠀weekends⠀if⠀necessary;
- Anticipate/recognize⠀potential⠀problems⠀with⠀equipment,⠀supplies,⠀documents,⠀or⠀processes⠀and takes⠀action to⠀resolve or⠀prevent⠀problems;
- Collaborate⠀with other⠀departments,⠀teams, and⠀stakeholders⠀and⠀through⠀negotiation⠀and⠀influence⠀gain their⠀consensus⠀and⠀support to⠀resolve⠀issues;
- Recognize⠀when to⠀communicate⠀or⠀escalate⠀issues to⠀management;
- Ability⠀to⠀accurately⠀complete⠀and⠀compile⠀official⠀documentation⠀per Rocket⠀Good⠀Documentation⠀Practices⠀(GDP)⠀requirements;
- Follow⠀verbal and⠀written⠀instructions⠀when⠀completing⠀assignments;
- Complete⠀tasks with⠀attention⠀to detail⠀and⠀right-first-time⠀mind⠀set;
- Perform⠀all⠀assignments⠀in a⠀manner⠀aligned⠀with⠀Rocket’s⠀values and⠀behaviors
Physical Requirements
- Constantly⠀works in a⠀cleanroom⠀environment⠀with⠀moving⠀mechanical⠀parts and⠀variable⠀noise⠀levels
- Constantly⠀works with⠀biohazard⠀materials⠀and⠀chemical⠀solutions⠀including⠀bleach and⠀Spor-Klenz®
- Constantly⠀wears⠀cleanroom⠀garments⠀(for⠀example,⠀composite-toed⠀safety⠀shoes,⠀safety⠀glasses,⠀coverall,⠀hairnet,⠀beard⠀cover,⠀shoe⠀covers,⠀nitrile⠀gloves,⠀face⠀mask)
- Occasionally⠀wears⠀cleanroom⠀PPE (for⠀example,⠀face⠀shield,⠀chemical⠀resistant⠀gloves)
- Must⠀be able to⠀remain in⠀a⠀stationary⠀position⠀for 50% of⠀the⠀time
- Must⠀be able to⠀detect and⠀distinguish⠀primary⠀colors⠀(red,⠀yellow,⠀and blue)⠀and⠀secondary⠀colors⠀(green,⠀orange,⠀and⠀purple) as⠀they⠀appear on⠀process⠀equipment⠀digital⠀displays⠀and⠀computer⠀screens
- Constantly⠀communicates⠀verbally⠀with⠀people to⠀exchange⠀information,⠀and give⠀and⠀receive⠀instructions
- Frequently⠀positions⠀self to⠀set-up,⠀operate,⠀clean, and⠀maintain⠀process⠀equipment⠀and handle⠀materials
- Frequently⠀positions⠀portable⠀equipment⠀weighing⠀up to 22⠀lbs. and⠀occasionally⠀positions⠀portable⠀equipment⠀weighing⠀up to 50⠀lbs.
- Frequently⠀moves⠀material⠀containers⠀weighing⠀up to 50⠀lbs.
- Seldom⠀ascend/descend⠀a portable⠀staircase⠀and works⠀at heights⠀up to 6⠀feet above⠀floor⠀level
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