Direct message the job poster from Specialty Search Group
Managing Member/Owner at Specialty Search Group, EVP Recruitment & Operations at Blue Ocean Hire
Quick Overview
We’re building a high‑compliance third‑party logistics operation to support specialty biologic therapies and manufacturer partners. This is an early, high‑impact role‑perfect for a hands‑on operational leader who wants to design and run a regulated warehouse environment from the ground up. If you like building processes, leading a team, and owning the details that keep temperature‑sensitive therapies safe and compliant, we should talk.
What you’ll do
- Lead the planning, launch and day‑to‑day management of a regulated 3PL warehouse supporting biologic therapies.
- Design and implement SOPs for receiving, storage, inventory control, pick/pack/ship and quality checks.
- Stand up and manage cold‑chain systems, environmental controls and monitoring processes.
- Ensure compliance with federal and state requirements (cGMP/cGDP, DSCSA, FDA guidance) and partner with QA on audits and CAPA.
- Work with leadership to select and integrate WMS/TMS and related systems; support financial transaction flows as needed.
- Build the staffing model, hire and train warehouse personnel, and create performance metrics for accuracy, throughput and service.
- Serve as a primary operational contact for internal execs and external partners during launches and ramp.
Who you are
- Operator who likes to build: you prefer creating systems and structure over just maintaining them.
- Comfortable with ambiguity: this is an early‑stage function and will evolve as the business grows.
- Detail oriented with a safety and compliance mindset — you understand what it takes to keep regulated product moving safely.
- A collaborative leader who can coach a small team and scale processes over time.
Must‑have qualifications
- Demonstrated experience managing or standing up regulated warehouse operations (pharma, biotech or specialty distribution preferred).
- Practical knowledge of cold‑chain logistics and biologics handling (ambient + refrigerated).
- Working familiarity with cGMP/cGDP, DSCSA (track & trace) and common FDA warehouse expectations.
- Experience writing SOPs and establishing operational controls and metrics.
- Comfortable working with WMS/TMS systems and participating in technology selection.
Nice‑to‑have
- Background in 3PL or specialty pharmacy distribution.
- Exposure to FDA audit processes or regulated facility builds.
- Familiarity with financial integrations (order‑to‑cash, rebate posting workflows).
- DEA regulatory knowledge (note: this operation will not handle controlled substances).
Working conditions & logistics
- This role reports to the General Manager and will be closely involved with executive leadership in the early stages.
- Initial team will be small; the role will grow as volume and partnerships expand.
- Final warehouse location is to be determined; candidate must be open to relocation if required.
Seniority level
Employment type
Job function
- Manufacturing, Management, and Quality Assurance
- Pharmaceutical Manufacturing