Production Operations Manager

2 weeks ago

Englewood, Colorado, United States Leiters Inc Full time
Job Overview

Position: Manufacturing Manager

This role reports to the Head of Manufacturing and is accountable for overseeing the Filling and Formulation sectors of production. The Manufacturing Manager will manage daily operations, including the sanitization of classified environments. This position requires collaboration with maintenance and supply chain teams to ensure that Leiters Inc. achieves its operational objectives.

Why Choose Leiters Inc.?

Are you driven to make a significant difference in the pharmaceutical sector? Do you excel in a collaborative and innovative setting where your contributions are valued? At Leiters Inc., we are looking for skilled professionals to become part of our vibrant team.

Leiters Inc. is not just another pharmaceutical entity; we are leaders in our field, committed to providing high-quality compounded sterile products and outsourced solutions to healthcare providers across the nation. Our dedication to excellence and patient safety is central to our mission.

  • Innovative Environment: Engage with a forward-thinking organization that promotes creativity and continuous improvement.
  • Impactful Work: Be part of a purpose-driven company focused on delivering essential medications and healthcare solutions that enhance patient lives.
  • Career Growth: Benefit from ongoing training, mentorship, and opportunities for advancement in a rapidly evolving industry.
  • Advanced Technology: Work with cutting-edge facilities and technologies, ensuring you remain at the forefront of pharmaceutical manufacturing.
  • Team-Oriented Culture: Collaborate with passionate individuals committed to teamwork and mutual success, fostering an inclusive environment.

Ideal Candidate Profile:

We are in search of motivated individuals who are adaptable and enthusiastic about contributing to a mission-focused organization. Whether you are an experienced professional or at the beginning of your career, Leiters Inc. offers an environment where your abilities will be recognized and valued.

Key Responsibilities:

  • Provide effective leadership, focusing on fostering a positive workplace through clear communication and accountability. Oversee supervisors managing aseptic filling, formulation, and classified cleaning operations, including:
    1. Personnel development and training
    2. Performance evaluations, coaching, and feedback
    3. Time and attendance management
    4. Employee relations and disciplinary actions
  • Lead and supervise manufacturing resources to achieve production schedules and targets.
  • Coordinate and oversee projects related to aseptic filling, formulation, and classified cleaning functions, including defining project scope, resource identification, and scheduling.
  • Act as a liaison among Production, Facilities, Engineering, Validation, Technical Services, Quality Assurance, and Supply Chain to schedule and monitor manufacturing processes and product quality.
  • Develop and maintain key performance indicators (KPIs) specific to aseptic filling and formulation.
  • Identify and implement continuous process improvements within the manufacturing environment.
  • Create and update Standard Operating Procedures (SOPs) for new and existing equipment/processes.
  • Ensure employee training on SOPs and processes is current.
  • Maintain and schedule necessary qualifications.
  • Analyze production efficiencies, focusing on downtime and waste, and lead teams to enhance outcomes.
  • Write and review investigations and corrective actions for non-conformances, collaborating with Quality Assurance to resolve issues promptly.
  • Manage staffing levels and budget expenditures.

Qualifications and Skills:

  • Minimum of 5 years of experience in a supervisory role within a cGMP FDA-regulated pharmaceutical manufacturing environment; 2 or more years in aseptic processing preferred.
  • Familiarity with cGMP guidelines and standards.
  • Bachelor's degree or equivalent experience in Biology, Chemistry, Microbiology, or a related field preferred.
  • Lean Six Sigma training, Green Belt or Black Belt preferred.
  • Strong written and verbal communication skills, including presentation abilities.
  • Comprehensive knowledge of process equipment, unit operations, and safety protocols.
  • Self-motivated, highly organized, and detail-oriented with effective interpersonal skills.
  • Able to work independently and collaboratively in a fast-paced environment.
  • Proficient in Microsoft Office, particularly spreadsheets and word processing software.

Benefits:

  • Comprehensive employer-paid medical plan.
  • Dental and vision insurance options, including FSA and HSA.
  • Employer-paid life insurance and employee assistance program.
  • Short-term and long-term disability insurance.
  • 401K matching up to 4% (100% vested from day one).
  • Generous paid time off, including vacation, sick leave, and holidays.
  • Annual tuition reimbursement after 6 months of employment.
  • Referral bonus program with no limits.
  • Eligibility for an annual bonus program.

Equal Opportunity Employer: We are an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity or expression, pregnancy, age, national origin, disability status, genetic information, protected veteran status, or any other characteristic protected by law.

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