Careers

Join a team delivering high impact therapies with speed and quality.

Benefits

Benefits include medical/dental/vision, 401(k) with match, PTO, remote flexibility (role dependent), tuition & certification support, and structured career development.

Medical / Dental / Vision
401(k) with Company Match
Paid Time Off (PTO)
Remote Flexibility (Role Dependent)
Tuition & Certification Support
Structured Career Development

A) Manufacturing, Quality & Engineering (On Site)

1) Quality Engineer — cGMP Manufacturing
Location: Bristol, PA (Keystone Industrial Park) | Type: Full time, On site | Req ID: QE PA 001
+

Summary: Ensure product quality and compliance across batch execution, investigations, and validation.

Responsibilities

  • Line clearances, batch record review, deviations/OOS/OOT investigations
  • CAPA/root cause, change control, risk assessments
  • Support IQ/OQ/PQ, cleaning/process validation, tech transfer
  • Internal audits; inspection readiness; SOPs & WIs

Qualifications

  • BS Engineering/Life Sciences; 3+ yrs cGMP experience
  • 21 CFR 210/211, ICH Q9/Q10, ALCOA+; strong QMS/validation exposure
Apply
2) Validation Engineer — Pharma/Device
Location: Irving, TX (Lone Star Industrial Way) | Type: Full time, On site | Req ID: VE TX 002
+

Responsibilities

URS/DQ/IQ/OQ/PQ execution; utility/facility qualification (HVAC, WFI); cleaning & sterilization validation; EM support; protocol/report authorship.

Qualifications

BS Engineering; 2–5 yrs validation; FDA/ICH validation know how.

Apply
3) Manufacturing Technician — Aseptic
Location: Tempe, AZ (Sonoran Industrial Park) | Type: Full time, On site | Req ID: MT AZ 003
+

Responsibilities

Operate filling/lyo/sterilization; aseptic manipulations in ISO cleanrooms; documentation; EM compliance.

Qualifications

HS/Associate; 1–3 yrs sterile ops preferred; gowning certified a plus.

Apply
4) Quality Control Analyst — Chemistry/Micro
Location: Wixom, MI (Great Lakes Tech Park) | Type: Full time, On site | Req ID: QC MI 004
+

Responsibilities

HPLC/GC/UV/FTIR; bioburden/endotoxin/sterility (role dependent); method validation; stability; LIMS entries.

Qualifications

BS Chemistry/Micro; 1–4 yrs QC lab.

Apply
5) Senior Process Engineer — OSD & Sterile
Location: Bristol, PA | Type: Full time, On site | Req ID: SPE PA 005
+

Responsibilities

Scale up, DoE, process characterization; tech transfer; process monitoring (CPV); PPQ; yield/OEE improvements.

Qualifications

BS/MS ChemE/PharmSci; 5+ yrs process engineering.

Apply
6) Device Quality Manager — ISO 13485
Location: Norcross, GA | Type: Full time, On site | Req ID: DQM GA 006
+

Responsibilities

QMS per ISO 13485 & 21 CFR 820; design controls; supplier quality; NC/CAPA; UDI; audit readiness.

Qualifications

BS Eng/Life Sci; 6+ yrs device quality.

Apply
7) CSV Lead — GxP Systems
Location: Elk Grove Village, IL | Type: Full time, On site/Hybrid | Req ID: CSV IL 007
+

Responsibilities

Validation strategy for QMS/LIMS/MES/EDC; risk based CSV; 21 CFR Part 11 & data integrity; SOPs.

Qualifications

5+ yrs CSV; regulated systems experience.

Apply
8) Sterility Assurance Lead
Location: Tempe, AZ | Type: Full time, On site | Req ID: SAL AZ 008
+

Responsibilities

Aseptic process design; media fills; EM trending; sterilization validation oversight; contamination control strategy.

Qualifications

Microbiology background; 5+ yrs aseptic QA/SA.

Apply
9) QA Specialist — Batch Records & Release
Location: Plainfield, IN | Type: Full time, On site | Req ID: QA IN 009
+

Responsibilities

eBR/BR review; lot disposition support; deviations/CAPA; change control; audit support.

Qualifications

3+ yrs QA in pharma/biologics.

Apply
10) EHS Manager — GMP Facilities
Location: Carlsbad, CA | Type: Full time, On site | Req ID: EHS CA 010
+

Responsibilities

EHS programs; hazardous materials; HPAPI controls; OSHA/EPA compliance; training; incident investigations.

Qualifications

6+ yrs EHS in life sciences.

Apply

B) Clinical Research & Medical (Remote/Hybrid)

11) Clinical Research Associate (CRA) — Phase I–III
Location: Remote (USA) | Travel: 40–60% | Req ID: CRA US 011
+

Summary: Conduct on site/remote monitoring to uphold subject safety and data integrity per ICH GCP.

Responsibilities

SIV/IMV/close out; IP accountability; safety reporting; TMF upkeep; feasibility & start up support.

Qualifications

BS Life Sci; 2+ yrs CRA; eTMF/CTMS experience.

Apply
12) Clinical Project Manager
Location: Remote (USA) | Req ID: CPM US 012
+

Responsibilities

Lead Phase I–IV studies; budget/timeline/vendor oversight; risk management; cross functional leadership; governance & reporting.

Qualifications

5+ yrs clinical PM; regulatory interactions preferred.

Apply
13) Medical Writer — Regulatory & Clinical
Location: Remote (USA) | Req ID: MW US 013
+

Responsibilities

Protocols, IBs, CSRs, DSURs, Module 2/3 contributions; consistency, clarity, scientific accuracy.

Qualifications

Advanced degree preferred; 3+ yrs clinical/regulatory writing.

Apply
14) Pharmacovigilance (PV) Scientist
Location: Remote (USA) | Req ID: PV US 014
+

Responsibilities

Case processing; MedDRA coding; narratives; signal management; aggregate reports (PBRER/DSUR); benefit risk.

Qualifications

3+ yrs PV; Argus/Safety DB familiarity.

Apply
15) Regulatory Affairs Manager — Drugs & Devices
Location: Remote (USA) | Req ID: RA US 015
+

Responsibilities

IND/IDE, NDA/BLA/ANDA, 510(k)/PMA strategies; briefing books; eCTD publishing; HA interactions.

Qualifications

5+ yrs RA; cross functional leadership.

Apply
16) PK/PD Scientist — Clinical Pharmacology
Location: Remote (USA) | Req ID: PKPD US 016
+

Responsibilities

PopPK/ER modeling; NCA; dose selection; DDI/FE studies; labeling support.

Qualifications

MS/PhD Pharmacometrics/PharmSci; 3+ yrs.

Apply

C) Biometrics, Data & Analytics (Fully Remote)

17) Clinical Data Manager
Location: Remote (USA) | Req ID: CDM US 017
+

Responsibilities

EDC build/validation; CRFs/edit checks; data cleaning; SAE reconciliation; DMPs; DBL.

Qualifications

3+ yrs CDM; Rave/Medrio/Veeva proficiency.

Apply
18) Biostatistician — Clinical Trials
Location: Remote (USA) | Req ID: BIO US 018
+

Responsibilities

SAPs; randomization; interim/topline/final analyses; SDTM/ADaM compliance; TLFs; regulatory submissions.

Qualifications

MS/PhD Biostats/Stats; SAS expert; 2–5 yrs.

Apply
19) SAS Programmer — CDISC
Location: Remote (USA) | Req ID: SAS US 019
+

Responsibilities

SDTM/ADaM datasets; TLF programming; define.xml; QC & validation; submission readiness.

Qualifications

3+ yrs clinical SAS; CDISC standards.

Apply
20) RWE/HEOR Analyst
Location: Remote (USA) | Req ID: RWE US 020
+

Responsibilities

EMR/claims analytics; CEA/BIM models; evidence synthesis; value dossiers; payer evidence.

Qualifications

Epidemiology/Health Econ; 2–4 yrs HEOR/RWE.

Apply
21) Data Analyst — Clinical & Manufacturing Analytics
Location: Remote (USA) | Req ID: DA US 021
+

Responsibilities

KPI dashboards (recruitment, DBL, query aging); manufacturing OEE/yield/deviation trending; SQL/Python/R; Power BI.

Qualifications

3+ yrs analytics; strong SQL + BI.

Apply
22) Data Engineer — GxP Data Platforms
Location: Remote (USA) | Req ID: DE US 022
+

Responsibilities

ETL pipelines; data lake optimization; metadata/governance; integrations (EDC/LIMS/MES/QMS).

Qualifications

4+ yrs data eng; Python/SQL; GxP data preferred.

Apply
23) LIMS Administrator
Location: Remote (USA) or On site (Wixom, MI) | Req ID: LIMS US 023
+

Responsibilities

Master data; workflows; user management; validation; audit trails; change control.

Qualifications

3+ yrs LIMS admin in GMP/QC.

Apply
24) MES Specialist — eBR/MES
Location: On site/Hybrid (Plainfield, IN) | Req ID: MES IN 024
+

Responsibilities

eBR design; recipe management; integrations (ERP/LIMS/QMS); change control; CSV.

Qualifications

3+ yrs MES in GMP.

Apply
25) TMF Specialist
Location: Remote (USA) | Req ID: TMF US 025
+

Responsibilities

eTMF oversight; completeness & timeliness; inspection readiness; metrics; reconciliation.

Qualifications

2+ yrs TMF; Veeva/Medidata/eTMF tools.

Apply
26) Clinical Trial Assistant (CTA)
Location: Remote (USA) | Req ID: CTA US 026
+

Responsibilities

TMF filing; tracking logs; site communications; meeting minutes; start up support.

Qualifications

1–2 yrs clinical admin; detail oriented.

Apply

How to Apply

Email careers@latral.com with Req ID in subject line.

Or apply via www.latral.com/careers (upload resume + brief cover note).

Recruiter review within 5 business days.

📧 careers@latral.com | 🌐 www.latral.com/careers