Manufacturing Manager

Jobtailor; Englewood (CO); On-site; USD 90,000 - 150,000; Full time

Job summary

Jobtailor in Englewood, Colorado seeks an experienced manufacturing operations leader to manage cGMP facilities and drive continuous improvement. You will generate documentation, lead a team of technicians and supervisors, and collaborate with cross-functional peers to ensure on-time production planning and regulatory compliance.

Ideal candidates have 4+ years in cGMP pharma environments, Six Sigma/Lean certification, strong problem solving and communication skills, and a proven track record in

Qualifications

• Bachelor's degree in a technical or relevant field, or equivalent experience.
• 4+ years of cGMP FDA pharmaceutical manufacturing facilities management.
• Advanced problem solving (Six Sigma/Lean) training; Green Belt or Black Belt preferred.
• Strong troubleshooting and root-cause analysis skills.
• Able to work in a fast-paced, adaptable environment.
• Strong written and oral communication and presentation skills.
• Understanding of 503B regulatory requirements, cGMP, and USP guidelines.
• Proficiency with Microsoft 365 including Outlook, Word, and Excel.

Responsibilities

• Generate, update and maintain documentation for manufacturing areas.
• Interact constructively with employees, managers and cross-functional peers.
• Deploy reliability strategies to execute the production plan on time and in full.
• Adhere to procedures, cGMP standards, policies, and safety/regulatory requirements.
• Utilize Lean Manufacturing and Six Sigma concepts to improve processes and asset utilization.
• Collaborate cross-functionally to address production problems promptly with quality focus.
• Coordinate deviation investigations and implement corrective actions to prevent recurrence.
• Suggest and implement innovative solutions for continuous improvement.
• Assist in arranging weekly production schedules.
• Analyze capital expenditures and efficiency improvements in manufacturing.
• Manage staffing levels and budget spending.
• Other duties as assigned.
• Directly hire and lead technicians, leads and supervisors.
• Foster a positive work environment with guidance, coaching and mentoring to achieve excellence and collaboration.
• Conduct regular 1:1s to address performance and feedback.
• Identify and facilitate training and development needs.

Skills

Leadership

Coaching

Mentoring

Communication

Collaboration

Problem solving

Adaptability

Relationship building

Guidance

Team management

Education

Bachelor's degree in technical field or equivalent

4+ years cGMP FDA pharma facilities management

Tools

Lean Manufacturing

Six Sigma

Root cause analysis

Troubleshooting

Capital expenditures analysis

Efficiency improvements

Production planning

Deviation investigations

Corrective actions

Continuous improvement

Job description

Responsibilities

• Generate, update, and maintain documentation associated with manufacturing areas.
• Interact constructively with employees, managers, and cross-functional peers.
• Deploy strategies in reliability to execute the production plan on time and in full.
• Adhere to and promote all applicable procedures, cGMP standards, company policies and any other safety, quality or regulatory requirements.
• Utilize Lean Manufacturing/Six Sigma concepts to improve manufacturing process, asset utilization and plant performance.
• Interact cross-functionally to ensure production problems are addressed promptly and with quality considerations.
• Coordinates relevant deviation investigations and implements corrective actions to prevent recurrence.
• Routinely suggest and implement innovative solutions focused on continuous improvement.
• Partner on the arrangement of weekly production schedules.
• Analyze and make recommendations regarding capital expenditures and efficiency improvements in manufacturing areas.
• Manage staffing levels and budget spending.
• Other duties as assigned.
• Directly hire and lead a team of technicians, leads, and supervisors.
• Foster a positive and productive work environment, providing guidance, coaching, and mentoring as needed to achieve a culture of excellence and collaboration.
• Conduct regular 1:1's to address performance, feedback and relationship building.
• Identify training and development needs within the team and facilitate as able.

Requirements

• Bachelor's degree in a technical or other relevant field or equivalent experience required.
• 4+ years of managing facilities for a cGMP FDA regulated pharmaceutical manufacturing environment required.
• Advanced problem solving such as Six Sigma and Lean training, Green Belt or Black Belt preferred.
• Strong Troubleshooting and Root cause analysis
• Able to work in a fast-paced environment and adaptable to change.
• Demonstrated written and oral communications skills including strong presentation skills.
• Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines required
• Proficient written, verbal and oral English communication skills are required.
• Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel.

Hard Skills

• Lean Manufacturing
• Six Sigma
• Root cause analysis
• Troubleshooting
• Capital expenditures analysis
• Efficiency improvements
• Production planning
• Deviation investigations
• Corrective actions
• Continuous improvement

Soft Skills

• Leadership
• Coaching
• Mentoring
• Communication
• Collaboration
• Problem solving
• Adaptability
• Relationship building
• Guidance
• Team management

Certifications & Qualifications

• Green Belt
• Black Belt