Harrow, Inc.

Harrow, Inc.

Pharmacist in Charge (PIC)

Ledgewood, NJ

Sponsorship not specifiedDetected 35 days ago
ExpressComplianceAuditingPharmacy PracticeGMPLeadershipCommunicationInternal Audit

About the role

  • The PIC position requires a high level of knowledge across aseptic manufacturing, good manufacturing practices, quality, and regulatory compliance.
  • NOTE: Core responsibilities will be finalized based on the incumbent's expertise and the organizational needs of the company.

Responsibilities

  • Regulatory Communication & Support
  • Support regulatory inquiries, deficiency responses, and follow-up actions within the defined scope of responsibility.

Requirements

  • Support policies, procedures, and operational practices required to maintain facility and pharmacist licensure and good standing.
  • Doctor of Pharmacy (PharmD) or Bachelor of Science in Pharmacy (BSPharm).
  • Active, unrestricted pharmacist license in good standing (state(s) as required by the organization as listed below and ability to obtain licensure in additional states as requested:
  • Minimum 5-7 years of pharmacy experience, including GMP and regulatory or compliance-related responsibilities.
  • Demonstrated knowledge of sterile compounding, ADE & complaint management, and controlled substance regulations.
  • Familiarity with DEA, State Board of Pharmacy, accrediting organizations, and patient safety standards.

Nice to have

  • An expanding Retina Portfolio including IHEEZO ®, TRIESENCE ®, BYOOVIZ TM, and OPUVIZ TM
  • A broad Dry Eye Disease product line, led by VEVYE ® and bolstered by well-known adjacent ocular surface disease products such as FLAREX ® and FRESHKOTE ®
  • A peri-operative Surgical product line, led by TRIESENCE ®, and BYQLOVI TM
  • A Rare and Specialty product line, which includes various high-need and utility products such as ILEVRO ®, NATACYN ®, and VERKAZIA ®
  • A robust internal development pipeline with multiple late-stage candidates, including MELT-300, MELT-210, H-N08, and CR-01
  • QA Oversight of Production
  • Participate in investigations related to potential or actual deviations, out-of-specification results, or other incidents related to the drug product
  • Respond to internal audit findings

Skills

  • Strong written and verbal communication skills, including regulatory correspondence.

Company info

  • Before reading the job post, we encourage you to watch this video about our company.
  • It gives you an inside look at how we started, the team and culture that made us successful, and where we're going.
  • It's easy to read a job post and apply, but people often wonder about the culture and whether they would fit in.
  • If you want to call Harrow your home and genuinely want to be part of a family and something big, then we encourage you to click this link and get to know us.
  • Who is Harrow?
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