You are applying for a position through Medix, a staffing agency. The actual posting represents a position at one of our clients.

Job Summary

Our client is seeking a Consultant to serve as the lead expert in facility layout, equipment specification, and implementation of compliant processes. This role involves guiding the organization through initial buildout, the development of policies and procedures, and preparing for 503B certification and commercial production.

Key Responsibilities

• Advise on equipment selection, layout, and facility design to support GMP, non-sterile, and IV compounding, with a focus on regulatory compliance and workflow optimization.
• Guide project stages from blueprint review to on-site vendor meetings, ensuring cGMP and 503B readiness.
• Develop and write comprehensive policies and procedures, including compounding, environmental monitoring, and quality systems.
• Ensure the facility and quality systems align with FDA 503B regulations and cGMP requirements (21 CFR Parts 210/211).
• Mentor and collaborate with leadership and staff, providing expertise in product portfolio definition, workflow, training, and documentation.
• Support the organization during regulatory preparations, audits, and potential inspections.
• Remain flexible to varying workload; responsibilities range from policy writing to on-site review, depending on project phase.

Qualifications

• At least 10 years of progressive experience with 503B outsourcing facility buildout and GMP manufacturing.
• Demonstrated track record designing, launching, and supporting 503B compounding operations, particularly with peptides, including IV and non-sterile compounding.
• Thorough knowledge of cGMP standards, FDA requirements for 503B, and regulatory audit preparation.
• Experience in designing facility layouts and leading equipment procurement and validation activities for compounding or manufacturing.
• Ability to craft and implement written policies and procedures for sterile/non-sterile operations, quality control, and compounding workflows.
• Willing to work in a flexible part-time contractor capacity, with the ability to travel to Indianapolis, IN, as needed (Midwest location required).

Additional Requirements

• Flexible commitment ranging from 5 to 40 hours/week based on project needs.
• Expected initial duration: 6 months, with possibility to extend or transition to permanent role.
• Remote/home-based work is acceptable, but regular travel to the site in Indianapolis, IN, will be required.

Benefits

• Paid Sick Leave (Medix provides paid sick leave according to state and local sick leave ordinances).
• Health Benefits / Dental / Vision (Medix offers 6 different health plans: 3 Major Medical Plans, 2 Fixed Indemnity Plans (Standard and Preferred), and 1 Minimum Essential Coverage (MEC) Plan. Eligibility for health benefits is based on verifying that an average of 30 hours per week during the first 4 weeks of the work assignment has been met. If you meet eligibility requirements and take action to enroll, you will be covered no earlier than 60 days into your assignment, depending on plan selection(s)).
• 401k (Eligible on the first 401k open enrollment date following 6 consecutive months on assignment. 401k Open Enrollment dates are 1/1, 4/1, 7/1, and 10/1).
• Short Term Disability Insurance.
• Term Life Insurance Plan.

^*We will consider for employment all qualified Applicants, including those with criminal histories, in a manner consistent with the requirements of applicable federal, state, and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance (FCIHO), Los Angeles Fair Chance Ordinance for Employers (ULAC), The San Francisco Fair Chance Ordinance (FCO), and the California Fair Chance Act (CFCA).

Medix Overview:

With over 20 years of experience connecting organizations with highly qualified professionals, Medix is a leading provider of workforce solutions for clients and candidates across the healthcare, scientific, technology, and government industries. Through our core purpose of positively impacting lives, we’re dedicated to creating opportunities for job seekers at some of the nation's top companies. As an award-winning career partner, Medix is committed to helping talent find fulfilling and meaningful work because our mission is to help you achieve yours.

^*As a job position within our Life Sciences division, a successful completion of a background check may be required as a condition of employment. This requirement is directly related to essential job functions including but not limited to: high-risk work environments (warehouse or industrial areas), high-risk/ high-error job duties that could result in life-threatening injury or death, operation of heavy-duty machinery, working with hazardous chemicals, exposure to other dangerous materials, such as drugs and sharp instruments. Due to these job duties, this position has a significant impact on the business operations and reputation, as well as the safety and well-being of individuals who may be cared for as part of the job position or who may interact with staff or clients.