The goal⠀of Product⠀Development⠀within⠀Global⠀Product⠀Supply⠀(GPS) is⠀to develop⠀new drug⠀candidates⠀and the⠀processes⠀to⠀manufacture⠀them into⠀commercial⠀realities.⠀This is⠀achieved⠀by⠀designing⠀and⠀conducting⠀a variety⠀of⠀experimental⠀studies⠀using the⠀latest⠀scientific⠀methods⠀and state⠀of the art⠀equipment⠀and⠀instrumentation.⠀The⠀development⠀process is⠀very⠀dynamic⠀with⠀performance⠀in both⠀laboratory⠀and⠀process⠀scale-up⠀facilities.⠀Scientific⠀rigor,⠀timeliness⠀and⠀compliance⠀with all⠀GMP and⠀federal/state/local⠀regulations⠀are a⠀necessity.
In⠀order for⠀the⠀development⠀process to⠀be⠀successful,⠀there must⠀be⠀excellent⠀collaboration⠀between⠀the⠀professional⠀and union⠀staffs.⠀Often, the⠀professional⠀staff will⠀need to⠀take a⠀hands-on⠀approach⠀during the⠀course of⠀an⠀experiment⠀as⠀necessary⠀based on⠀sound⠀scientific⠀judgment.⠀Involvement⠀of the⠀union⠀staff in⠀the⠀various⠀experimental⠀studies⠀and other⠀processes⠀is⠀determined⠀by the⠀professional⠀staff on a⠀case-by⠀case basis⠀because of⠀the⠀non-routine,⠀dynamic⠀nature of⠀the⠀development⠀process.
Daily⠀assignments⠀will be⠀based on⠀demonstrated⠀technical⠀competence⠀of the⠀individual⠀operator⠀and the⠀demands of⠀the⠀process.⠀Priorities⠀will be⠀set based⠀on the⠀needs of⠀the⠀business.⠀Both⠀written⠀procedures⠀and verbal⠀instructions⠀by a⠀supervisor⠀will be⠀executed⠀with⠀strict⠀attention⠀to safety⠀and⠀quality.⠀Accurate⠀and timely⠀execution⠀and⠀documentation⠀of⠀activities⠀and⠀results⠀are a⠀requirement.⠀Strict⠀adherence⠀to GMP,⠀federal,⠀state and⠀local⠀regulations⠀is⠀required.⠀Collaborative⠀work with⠀other⠀employees⠀is a⠀necessity⠀to achieve⠀departmental⠀and⠀company⠀goals
JOB FUNCTION:
- In⠀accordance⠀with⠀specific⠀instructions,⠀performs a⠀variety of⠀functions⠀involved⠀in the⠀preparation⠀of⠀packaged⠀clinical⠀supplies⠀including⠀filling,⠀labeling,⠀capping,⠀and⠀sealing a⠀variety of⠀vials,⠀bottles,⠀unit dose⠀blister⠀cards,⠀pouches or⠀other⠀containers⠀prepared⠀for use in⠀clinical⠀studies,⠀clinical⠀stability⠀or product⠀registration⠀use.
- Using⠀equipment,⠀assembles⠀combination⠀products/devices⠀to be used⠀in⠀clinical⠀studies.
- Performs⠀in process⠀sampling⠀during⠀operations⠀and⠀records⠀data⠀obtained.⠀Weighs⠀and/or⠀hand⠀counts⠀dosage⠀forms and⠀records⠀data⠀obtained⠀within the⠀appropriate⠀documents.
- Inspect⠀labels⠀(manually⠀and with⠀use of⠀electromechanical⠀equipment)⠀against⠀label⠀proofs and⠀other⠀supporting⠀documentation⠀for⠀confirmation⠀of but not⠀limited to⠀the⠀following⠀characteristics:⠀Count,⠀Variable⠀text,⠀Character⠀verification⠀and⠀Cosmetic⠀defects.⠀Label⠀inspection⠀must be⠀accurate⠀with no⠀room for⠀deviations.
- Completes⠀all⠀documentation⠀supporting⠀the⠀preparation⠀of⠀clinical⠀supplies⠀and label⠀inspection⠀through⠀interface⠀with⠀software-based⠀processing⠀instructions⠀and data⠀collection⠀systems⠀and use of⠀equipment⠀PLC's.
- Performs⠀product⠀inspection⠀of⠀supplies⠀using SAP⠀interface⠀or other⠀electromechanical⠀equipment⠀for⠀verifying⠀contents.⠀Through⠀interface⠀with SAP⠀performs⠀calculations⠀of label⠀and⠀product⠀accountabilities.
- Alerts⠀supervision⠀of any⠀irregularities⠀in⠀procedures⠀or⠀equipment⠀operations⠀Makes up⠀carriers⠀and⠀shippers⠀and⠀prepares⠀finished⠀supplies⠀for⠀shipment.
- Assist⠀in the⠀(re)qualification⠀and⠀(re)validation⠀of⠀processing⠀equipment.
- As⠀necessary,⠀cleans and⠀wipes⠀ceilings,⠀floors and⠀walls in⠀the⠀prescribed⠀manner.⠀Perform as⠀required⠀Visual⠀Inspection⠀of⠀Parenterai⠀Products,⠀(i.e.,⠀Liquid⠀filled and⠀Lyophilized⠀vials and⠀syringes).⠀This⠀requires⠀the⠀operation⠀of the⠀semi-automated⠀vial⠀inspection⠀machine or⠀the use of⠀manual⠀inspection⠀booths.
- Individuals⠀must pass⠀inspection⠀qualification⠀and⠀biennial⠀requalification⠀including⠀annual eye⠀exams.
- Completes⠀all⠀documentation⠀supporting⠀the⠀inspection⠀of⠀parenteral⠀supplies⠀through⠀interface⠀with⠀software-based⠀processing⠀instructions.
- Performs⠀other⠀duties of⠀equal or⠀lesser in⠀nature as⠀required⠀such as⠀but not⠀limited⠀to;⠀movement⠀of⠀material⠀between⠀work⠀locations,⠀organizing⠀CSO⠀warehouse⠀and⠀general⠀housekeeping.
- Follows⠀Current⠀Good⠀Manufacturing⠀Practices,⠀departmental⠀SOP's,⠀good⠀housekeeping⠀principles⠀and all⠀safety⠀rules.⠀Interfaces⠀with⠀computer⠀based⠀applications⠀for⠀self-paced⠀online⠀training⠀of both⠀company⠀and⠀departmental⠀policies⠀and⠀procedures.
- Follows⠀Current⠀Good⠀Manufacturing⠀Practices,⠀all safety⠀rules and⠀good⠀housekeeping⠀principles.
EDUCATION REQUIREMENTS :
- Two Year⠀Associates⠀degree or⠀equivalent.⠀In lieu of⠀a two-year⠀degree a⠀minimum⠀four years⠀applicable⠀experience⠀within a⠀CGMP⠀regulated⠀industry⠀will meet⠀requirements.
- Proficiency⠀in the use⠀of⠀computer⠀programs⠀/systems⠀is⠀essential.⠀Technicians⠀must⠀maintain⠀their⠀skills and⠀knowledge⠀current⠀with the⠀advances⠀in the⠀field of⠀Pharmaceutical⠀Development.⠀Incumbents⠀may attend⠀internal⠀or⠀external⠀training⠀courses as⠀approved⠀by⠀management.
Training⠀will be⠀implemented⠀to ensure⠀operators⠀receive⠀relevant⠀training⠀to⠀facilitate⠀the⠀performance⠀of their⠀job⠀responsibilities.⠀Assessment⠀after⠀training⠀specific⠀to a task⠀will be an⠀ongoing⠀requirement.⠀interactive⠀training⠀modules⠀may be⠀used for⠀training⠀on⠀specific⠀competencies.⠀If testing⠀is not⠀passed,⠀the⠀interactive⠀learning⠀and⠀testing⠀will be⠀repeated.
Working⠀Conditions:
Works⠀under⠀direction⠀of⠀supervision⠀and⠀follows⠀established⠀practices⠀in⠀performing⠀all⠀duties.⠀Makes a⠀decision⠀when⠀general⠀instructions,⠀established⠀methods,⠀or clearly⠀defined⠀precedents⠀indicate⠀action to⠀be taken,⠀but refers⠀unusual⠀problems⠀to⠀supervisors.⠀Department⠀requires⠀zero error⠀rate and⠀employs⠀multiple⠀redundant⠀checks to⠀achieve⠀this⠀objective.⠀Undetected⠀errors may⠀have⠀serious⠀implications⠀and may⠀result in⠀costly⠀withdrawals⠀or the⠀termination⠀of a⠀clinical⠀study.
Work⠀is routine⠀and⠀repetitive;⠀requiring⠀application⠀of⠀judgement⠀within⠀limitations⠀established⠀by CGMP⠀regulations,⠀defined⠀SOP's and⠀processing⠀instructions.⠀Required⠀to⠀document⠀operations⠀in⠀exacting⠀fashion⠀without⠀error.⠀Require⠀interface⠀with⠀computer-based⠀documents⠀and⠀instructions⠀such as⠀but not⠀limited to⠀SAP.
As⠀required,⠀handling⠀of potent⠀compounds⠀which⠀requires⠀annual⠀gown/respirator⠀training⠀and⠀medical⠀respirator⠀clearance.
Work⠀environment⠀may be⠀subject to⠀odors and⠀fumes,⠀dust,⠀powders,⠀oil,⠀grease,⠀and noise.⠀Significant⠀physical⠀effort⠀required.⠀It is⠀essential⠀that⠀incumbents⠀be⠀involved⠀in⠀stooping,⠀lifting,⠀bending,⠀sometimes⠀in awkward⠀positions.
Employees⠀must have⠀annual eye⠀exams and⠀be able to⠀qualify as⠀required⠀to perform⠀Visual⠀Inspection⠀of⠀Parenteral⠀Products⠀(i.e.,⠀Liquid⠀filled and⠀Lyophilized⠀vials and⠀syringes).⠀This⠀requires⠀individuals⠀to pass⠀Biennial⠀re-qualification.
Uniquely⠀Interesting⠀Work,⠀Life-changing⠀Careers
With⠀a single⠀vision as⠀inspiring⠀as⠀Transforming⠀patients'⠀lives⠀through⠀science™⠀, every⠀BMS⠀employee⠀plays an⠀integral⠀role in⠀work that⠀goes far⠀beyond⠀ordinary.⠀Each of us⠀is⠀empowered⠀to apply⠀our⠀individual⠀talents⠀and unique⠀perspectives⠀in an⠀inclusive⠀culture,⠀promoting⠀diversity⠀in⠀clinical⠀trials,⠀while our⠀shared⠀values of⠀passion,⠀innovation,⠀urgency,⠀accountability,⠀inclusion⠀and⠀integrity⠀bring out⠀the⠀highest⠀potential⠀of each of⠀our⠀colleagues.
On-site⠀Protocol
BMS⠀has a⠀diverse⠀occupancy⠀structure⠀that⠀determines⠀where an⠀employee⠀is⠀required⠀to conduct⠀their⠀work. This⠀structure⠀includes⠀site-essential,⠀site-by-design,⠀field-based⠀and⠀remote-by-design⠀jobs. The⠀occupancy⠀type that⠀you are⠀assigned⠀is⠀determined⠀by the⠀nature and⠀responsibilities⠀of your⠀role:
Site-essential⠀roles⠀require⠀100% of⠀shifts⠀onsite at⠀your⠀assigned⠀facility.⠀Site-by-design⠀roles may⠀be⠀eligible⠀for a⠀hybrid⠀work model⠀with at⠀least 50%⠀onsite at⠀your⠀assigned⠀facility.⠀For these⠀roles,⠀onsite⠀presence⠀is⠀considered⠀an⠀essential⠀job⠀function⠀and is⠀critical⠀to⠀collaboration,⠀innovation,⠀productivity,⠀and a⠀positive⠀Company⠀culture.⠀For⠀field-based⠀and⠀remote-by-design⠀roles the⠀ability to⠀physically⠀travel to⠀visit⠀customers,⠀patients⠀or⠀business⠀partners⠀and to⠀attend⠀meetings⠀on behalf⠀of BMS as⠀directed⠀is an⠀essential⠀job⠀function.
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