Lead Formulation Technician - First Rotating

Work Schedule

Environmental Conditions

Job Description

Summary

Operates equipmentused to manufacture products. Weighs, measuresand checks rawmaterialsto ensurethat batches manufacturedcontainproperingredients in proper quantities.(Serves as SME) Acts as a SME (technical expertise) and demonstrates mastery of tasks andprocessesin manufacturingdrug productinjectables in a cleanroom environment andfollowingGMP standards.Conduct qualityinvestigationsand support process optimizations.Autonomouslyrunequipment,pumps,and automated systemsand trainteammemberstoensure it's rightthe first time and on schedule.Push fluids through filters inchromatography columns.Set flow paths forthe operations,following SOPs and Batchrecordsand recommendingimprovements.

Responsibilities

• Acts asa Lead technicianon thefloorprovidingguidancetoothertechniciansand driving daily operations.Providecriticalevaluationofprocesses,including foresightandthinking ahead. Actasaguideto newemployeesduringonboardingprocess. Has substantial understandingof thejoband appliesknowledgeand skillstocomplete a widerange oftasks.

• High LevelSkilled:Aseptic GowningImaterial flow, Applicable processingequipment,SAP/BLV. Works on assignments that are moderately difficult,requiring judgmentinresolvingissuesor in makingrecommendations.

• High impacttowork. Performs all dutiesinstrict compliancewithStandard OperatingProcedures,GoodManufacturingPractices, GoodLaboratory Practices,and Safety guidelines.Maintainsthenecessary compliance status requiredbycompanyand facilitystandards.

• Stays up to date on required job training. Maintains up to date training records. Qualified trainer on all complex equipment/processes. Completed QT-SME curricula, Support training revisions, and new equipment development.

• SME or Expert on >3Unit Operations.Obtains samples ofbatches/productsinaccordance with company procedures; submits samplesto required functional areasfor testing and todeterminespecific properties.Records/analyzes results andtakesappropriate action.

• Responsible fortheupkeep of manufacturing equipment.Recognizesequipment and product problems, notifies supervisorand/or troubleshoots errorsinorder to achieveoptimum productionlevels. Assist repair efforts, to increase understanding of equipment below the surface.

• Review, revise,&authormanufacturing batchrecords. Collaborate with Quality &PD to review &signoffon executed batch records.Own the batchrecord reconciliation.Review,revise,& Author Wls/SOPs. Participate in lot disposition meetings and addresses client comments as needed.

• Adhereto theQualityManagementSystems bylivingtheQuality values everydayandholdspeers across the site accountable as well. Assistwiththeon-time closure ofNonconformance's/ CAPAs. Assists in QUIC submission, and triage as needed.

• Lead PPI/JDI initiatives and continuous improvements. Encourages peers to think outside the box, coaching team to make documented improvements to process, maintaining attribution during idea flow to make team shine.

• Identify andcommunicateitems requiringescalation; execute post escalation decisions.Providefrequent feedbackand coachingtoothers on ways toimproveperformance.Receives and checks rawmaterials andformulation deliveriesand completes appropriate records in accordance with company procedures(MFP's/EOP's/LOP's/SOP's).

• Active participant of performance huddles and assist supervisors to plan out and populate process schedules, including break timing.

• Maintaina culture of safetybyidentificationofnearmisses,safetywalkthroughsand assisting with resolution of safety observations.Ensure chemicals are properly stored andlabeled. Leads daily safety chats with team to identify relevant hazards of process.

• 90% of time spent on the floor
• Work Hours:
  • This position will generally require the ability to work a 12-hour rotating shift in a 24-hour, 7 day per week operation to include evenings and holidays.

•  Education/Experience/Equivalency:
  • High School Diploma/ 4+ years of relevant experience or superior demonstration of skill sets or background

• Knowledge, Skills and Abilities:Full GMP understanding.Demonstrated abilitytolead and mentor.Understandingofthescience behind theprocesswithabilityinterpretdataandinputs.Strongcommunication skills (verbal and written). Good autonomousproblem­solving skills.Investigativeskills.Understandcleanroom concepts. Ability to followdirections &proceduresand workinteamenvironment.Strong attentionto detailand drive toaccomplish thejobtimely,accurately, and safelythefirsttime is required,as well as the abilitytowork closelyand effectively in ateamenvironment. This position willgenerally require theabilitytowork a12-hour rotating shiftina24-hour,7day perweek operationto includeeveningsandholidays. Abilitytoapplyknowledgeof GoodManufacturing processesandthe knowledgeand skillsin pharmaceuticalprocesses,equipment, instrumentation,andprocedures.Adhereto allPersonalProtective Equipment (PPE)requirementsused withincGMPmanufacturing. 
• Physical Requirements:Employee is regularlyrequiredtostand;usehands tofinger,handle,orfeel;reach withhands and arms;sitand to talk or hear. Theemployee is requiredtowalk and stoop,or kneel,crouch approximately80%ofthetime.Theemployee isrequired toascend/descendstairsapproximately20%of the time, liftamaximumof 50lbs.,and sitforamaximumof4 hours.Specificvision abilities requiredby thisjobincludeclose visionand ability to adjust focus withtasks.

 Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $25 billion. Our Mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies or increasing productivity in their laboratories, we are here to support them. Our global team of more than 75,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services through our industry-leading brands, including Thermo Scientific, Applied Biosystems, lnvitrogen, Fisher Scientific, Unity Lab Services and Patheon. For more information, please visitwww.thermofisher.com.

Compensation and Benefits

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs

• Employee assistance and family support programs, including commuter benefits and tuition reimbursement

• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy

• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan

• Employees’ Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit:https://jobs.thermofisher.com/global/en/total-rewards