Director of Manufacturing / Plant Manager - 503B Outsourcing Facility

Director of Manufacturing / Plant Manager

• 503B Outsourcing Facility at Friday Plans Director of Manufacturing / Plant Manager
• 503B Outsourcing Facility at Friday Plans in Kansas City, Kansas Posted in 4 days ago.

Type:

full-time

Job Description:

Director of Manufacturing / Plant Manager

• 503B Outsourcing Facility Friday Plans
• Kansas City, KS (on-site)
• Reports to CEO 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 have acquired a 90
• complete, ~10,000 sq ft greenfield 503B facility (with ~6,000 sq ft of compounding space) in Kansas City and are assembling the founding leadership team to take it through commissioning, FDA registration, and commercial launch.

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 Kansas City 503B

• owning manufacturing flow, equipment commissioning, production scaling, and the daily operating system that keeps batches 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 ship our first commercial batch 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. cGMP Compliance
• 21 CFR 210/211, USP , FDA 503B guidance, Kansas 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 batch 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 (~10-15 FTEs at steady state).

What You Bring Required 10+ years pharmaceutical manufacturing in cGMP environments with progressive leadership 5+ years 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 FDA inspections and state board / customer audits Deep working knowledge of 21 CFR 210/211, USP , and

FDA 503B

guidance 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 (Kansas 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 manufacturing facility you have personally commissioned, scaled, or substantially rebuilt to careers@fridayplans.com. Friday Plans is an equal opportunity employer.