Director of Manufacturing / Plant Manager — 503A Sterile Compounding Pharmacy

About Friday Plans

Friday Plans is one of the largest direct-to-consumer telehealth brands in the US, dispensing FDA-approved prescription medications through US-licensed pharmacies. We are profitable, well-capitalized, and vertically integrating.

We are building out a ~100,000 sq. ft. greenfield 503A facility (with ~15,000 sq. ft. of compounding space) in Houston and are assembling the founding leadership team to take it through commissioning, Texas Board of Pharmacy licensure, and first patient-specific compounding. The site will produce sterile injectable peptides, solid oral dose, and nasal spray preparations.

This is a builder's role, not a maintenance role.

The Role

You will be the founding operations leader at our Houston 503A — owning manufacturing flow, equipment commissioning, production scaling, and the daily operating system that keeps compounded preparations moving safely, compliantly, and on time.

You will report directly to the CEO and partner shoulder-to-shoulder with the VP of Quality from day one. The cleanroom shells are in. We need someone to finalize equipment, lead IQ/OQ/PQ, hire the production team, and release our first compounded preparations across three dosage forms.

What You'll Own

• Manufacturing Operations — production planning, scheduling, batch execution across sterile injectable peptide, solid oral, and nasal spray lines. Walk the floor daily. Maintain a state of control.
• Facility Commissioning — final equipment selection and installation, IQ/OQ/PQ qualification of equipment, utilities, HVAC, water systems, cleanrooms (with VP Quality and Validation Engineering).
• Sterile Operations — formulation, aseptic compounding, fill-finish, inspection, labeling. ISO 5/7/8 cleanroom compliance through gowning, behavior, EM partnership with QA.
• Multi-Dosage-Form Production — segregated flows preventing cross-contamination across sterile, oral, and nasal lines. Peptide-specific handling, stability, and excipient considerations.
• Compounding Compliance — USP <795>, <797>, and <800>, Section 503A of the FD&C Act, FDA 503A guidance, Texas State Board of Pharmacy. Continuous inspection readiness.
• Performance & Continuous Improvement — KPIs for yield, cycle time, on-time release, capacity utilization. Lean / 5S / Six Sigma to eliminate bottlenecks.
• Cross-Functional Partnership — shoulder-to-shoulder with VP Quality on facility flow and compounding records; Supply Chain on raw materials; Regulatory on FDA submissions.
• Team Building — recruit, hire, train, and lead the founding manufacturing team: aseptic operators, compounding techs, packaging, supervisors, shift leads (~30-50 FTEs at steady state).

What You BringRequired

• 10+ years of pharmaceutical compounding or manufacturing in cGMP and/or USP <797> sterile compounding environments with progressive leadership
• 5+ years of supervisory or management experience leading sterile/aseptic production teams
• Direct sterile injectable manufacturing experience — fill-finish, aseptic compounding, cleanroom production
• Hands-on experience with facility startup, commissioning, and IQ/OQ/PQ — greenfield or major capacity expansion preferred
• Track record managing state Board of Pharmacy inspections, FDA inspections, and customer/accreditation audits
• Deep working knowledge of USP <795>, <797>, and <800>, and Section 503A of the FD&C Act
• Bachelor's in Engineering, Pharmacy, Pharmaceutical Sciences, Chemistry, or related

Preferred

• 503A or 503B compounding experience
• Advanced degree (MS, MEng, PharmD, MBA)
• US Pharmacist license (Texas eligibility a plus)
• Lean Six Sigma Green Belt or higher
• Peptide manufacturing experience (sterile fill-finish, oral, or nasal)
• Multi-dosage-form facility experience (sterile + non-sterile)

You are

• A hands-on operator. You walk the floor daily; you know the equipment and the operators by name.
• A builder, not a maintainer. You're excited by an empty cleanroom and a roadmap.
• Aligned with Quality. You and the VP of Quality should agree more than you disagree.
• Bias to action. The buck stops at your office.

To apply: Send your CV and 3–5 sentences on a sterile compounding or manufacturing facility you have personally commissioned, scaled, or substantially rebuilt to ***email_hidden***.

Friday Plans is an equal opportunity employer.