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Manufacturing Manager
Kaléo Richmond, VA
Full Time | Sports & Recreation 6 Months Ago
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Kaléo is Hiring a Remote Manufacturing Manager

This position is open to qualified candidates located in the United States and requires occasional travel.

At Kaléo, we believe that each of us is purposefully driven to make a difference in the lives of patients and our industry. As an integral part of our Manufacturing team, the Manufacturing Manager holds a key role in delivering our life-transforming products into the hands of patients. The ideal candidate for this role is a proactive thought-partner who can provide leadership to maintain a science-based, risk-averse, and quality-compliant manufacturing culture.

This impactful team leader is responsible for overseeing device assembly and fill/finish Contract Manufacturing Organizations (CMO) processes, relationships with Kaléo stakeholders, performance management, inventory management, and troubleshooting/resolution of routine operational issues and investigations to ensure efficient and effective commercial operations across the entire manufacturing supply chain. This individual also owns the Manufacturing Engineering function at Kaléo. This function is responsible for, directly or through the use of technical resources at CMOs, the support, troubleshooting, and scientific oversight of the automated manufacturing processes for Kaléo and sustainment of Design History Files.

If you are a strong leader and experienced subject matter expert in drug and combination product manufacturing, this is a phenomenal opportunity to be part of an exciting, fast-paced program producing a life-saving product. 

As Manufacturing Manager you will:

  • Represent Kaléo while managing CMO locations for manufacturing operations, sterile drug filling, and automation suppliers.
  • Directly manage an engineering specialist and oversee the Manufacturing Engineering function at Kaléo.
  • Provide leadership for drawings, specifications, and part number management for approved commercial products.
  • Monitor and influence CMO Key Performance Indicators (KPIs), schedule adherence, and cycle-times.
  • Manage routine Production activities such as manufacturing oversite, inventory management, warehousing, safety stock adherence, deviation processing, etc.
  • Partner with Production Specialist to create and monitor production schedules at all CMO’s to meet approved Kaléo Supply Plans.
  • Evaluate and recommend continuous improvement projects with CMOs.
  • Utilize Statistical Process Control (SPC) to ensure achievement of CMO production and quality metrics.
  • Ensure execution of processes and standards to maintain existing manufacturing technologies for Kaléo’s drug/device combination products.
  • Analyze processes, data, and quality records; support investigations and make recommendations when failures occur. 
  • Review and assist in the implementation of Validation Protocols, Final Validation Reports, Quality System Procedures, Performance Qualifications and related documents.
  • Create and process change controls as needed in the Kaléo Change Control Quality System.
  • Conduct and manage risk analyses, technical review, and engineering solutions as part of Kaléo’s Design Control processes for approved product manufacturing.
  • Manage and develop business strategy and assist in establishing department goals.
  • Manage department expenses to ensure normal operations and projects are functioning within approved budget.
  • Escalate business / technical issues to appropriate subject matter experts (SMEs) / teams for timely feedback and resolution.

A successful Manufacturing Manager will have:

  • The ability to break down and solve complex problems using strategic thinking and statistical analysis.
  • Excellent communication skills, specifically the ability to listen and respond to cross-functional team member and stakeholder needs effectively.
  • Superior project management and organizational skills, specifically the ability to manage effectively through competing deadlines and project details.
  • Strong leadership skills and the ability to influence team members and external stakeholders to accomplish business goals and ensure compliance.
  • A results-oriented approach to work; the desire to proactively seek resolutions to technical challenges and drive towards long-term objectives.
  • Creative and innovative problem-solving capabilities, demonstrating a track record of improving or developing new systems, processes, tools, policies, or SOPs to ensure compliance with regulations, increase efficiency, or solve problems.
  • Commitment to fostering an inclusive work environment at the team level. 

To be considered for the position, you must have:

  • A bachelor’s degree in a science or technical discipline.
  • 5 years of experience in pharmaceutical or medical device manufacturing.
  • Experience with manufacturing operations in pharmaceutical sterile drug fill/finish environments.
  • Hands-on experience with cGMP and ISO Quality standards.
  • Experience collaborating with Contract Manufacturing Organizations.
  • Proficiency with Microsoft Office products.

Additional preferred qualifications:

  • Experience with the manufacture of combination drug/device products is preferred.
  • Advanced training or experience with cGMPs, CFR Title 21, ISO, Design Controls and relevant industry is preferred.
  • Experience with Statistical Process Control (SPC) or Statistical Quality Control (SQC) is preferred.

Job Summary

JOB TYPE

Full Time

INDUSTRY

Sports & Recreation

POST DATE

09/10/2022

EXPIRATION DATE

10/07/2022

WEBSITE

fitnessforumonline.com

HEADQUARTERS

FLORENCE, SC

SIZE

25 - 50

TYPE

Private

CEO

KAREN LEATHERMAN

REVENUE

$5M - $10M

INDUSTRY

Sports & Recreation

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The job skills required for Manufacturing Manager include Leadership, Continuous Improvement, Problem Solving, Production Schedule, Manufacturing Operations, Microsoft Office, etc. Having related job skills and expertise will give you an advantage when applying to be a Manufacturing Manager. That makes you unique and can impact how much salary you can get paid. Below are job openings related to skills required by Manufacturing Manager. Select any job title you are interested in and start to search job requirements.

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The following is the career advancement route for Manufacturing Manager positions, which can be used as a reference in future career path planning. As a Manufacturing Manager, it can be promoted into senior positions as a Production Control Director that are expected to handle more key tasks, people in this role will get a higher salary paid than an ordinary Manufacturing Manager. You can explore the career advancement for a Manufacturing Manager below and select your interested title to get hiring information.

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