Position Description:

Our managers are technical leads first in facilities/utilities operation and maintenance, with solid experience with Good Engineering Practices (GEPs) and Good Manufacturing Practices (GMPs) in a pharmaceutical environment. A working understanding of commissioning, validation, and field execution is strongly desired. We look for culture fit above all – our people are our most important asset, and great people make great teams! Our ideal manager will have experience leading projects of $1m or more and have managed teams of engineers and consultants on defined scopes of work.

·Responsibilities include hiring and training of Operations personnel.

·Scheduling, planning, assigning, and directing work to optimize utilization of resources and equipment.

·Performs operational tasks including compounding, aseptic filling, inspection, labeling, and packaging for vials, syringes, and cartridges in accordance with cGMP regulations.

·Develops production-related standard operating procedures, work instructions, and forms.

·Develops and reviews production and operating reports and directs the resolution of operational, manufacturing, and maintenance matters/issues.

·Evaluates production workflow and performs capacity analysis to determine production times, staffing requirements, and related costs to provide information for management decisions.

·Leads new equipment acquisitions as they pertain to capacity expansion and continuous improvement efforts.

·Ensures all established costs, quality, and delivery commitments are met.

Requirements:

·Bachelor’s degree in Chemical Engineering or related Life Sciences.

·Minimum 5-7 years of manufacturing operations management experience.

·Must have hands-on aseptic processing experience.

·Must be well versed in FDA, ISO, and OSHA regulations and requirements.

·Experience with 503B product compounding and regulations is a plus.

·Local Las Vegas candidate preferred; relocation assistance is available.

About Bespoke Pharmaceuticals

·Bespoke Pharmaceuticals, LLC is a pharmaceutical manufacturer that has recently established a new production facility in Las Vegas, Nevada. The company aims to become a leading developer and manufacturer of pharmaceuticals, with a focus on customer-friendly and cost-efficient packaging and delivery systems.

·Bespoke Pharmaceuticals has commissioned Korber’s Business Area Pharma to support them in designing and constructing their new production facility. Korber is providing Bespoke Pharmaceuticals consulting services in areas of process design, workflow, building layout, software selection, machinery, and auxiliary equipment.

·Bespoke Pharmaceuticals is actively seeking leaders in several key operational roles who are excited to be part of a facility start-up with the potential for professional growth. 

·We have recently partnered with Bespoke Pharmaceuticals to provide direct hire recruiting services. By applying to this position, you assume you are not applying to a direct full-time role within CAI. During the screening process, details surrounding the client's benefits will be provided.

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CAI and Bespoke are equal opportunity employers; we are proud to employ veterans and promote diversity and inclusion in our workplace. Diversity is a strength for our companies. We pledge to operate in a way that is fair and equitable to all – our employees, our customers, and the broader society.

This job description is not all inclusive and you may be asked to do other duties. CAI and Bespoke will also consider for employment qualified applicants with criminal histories in a manner consistent with the requirements of the Fair Chance Act (FCA) / Fair Chance Ordinance (FCO).