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 pivotal in overseeing the Filling and Formulation sectors of production. The Manufacturing Manager will be accountable for daily operations, including the sanitation of classified areas. 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 eager to make a significant contribution to the pharmaceutical sector? Do you excel in a collaborative and innovative atmosphere where your expertise is valued? Look no further – Leiters Inc is in search of skilled professionals to enhance our dynamic workforce.

At Leiters Inc, we are not merely another pharmaceutical entity; we are innovators 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 fundamental to our mission.

  • Innovative Environment: Be part of a progressive organization that promotes creativity, embraces new ideas, and nurtures continuous improvement.
  • Impactful Work: Contribute to a mission-driven company focused on delivering essential medications and healthcare solutions that improve patient outcomes.
  • Career Advancement: Benefit from ongoing training, mentorship, and opportunities for professional growth in a rapidly evolving industry.
  • Advanced Technology: Work with cutting-edge facilities and technologies, ensuring you remain at the forefront of pharmaceutical manufacturing.
  • Supportive Culture: Collaborate with a team of dedicated individuals committed to teamwork, support, and shared success, fostering an inclusive and collaborative atmosphere.

Ideal Candidate:

We are looking for motivated individuals who are adaptable and passionate about contributing to a purpose-driven organization. Whether you are an experienced professional or new to the field, Leiters Inc offers an environment where your skills and contributions will be recognized and valued.

Key Responsibilities:

  • Provide effective leadership focused on maintaining a positive workplace through clear communication and accountability. Supervise team leaders responsible for aseptic filling, formulation, and classified cleaning operations, which includes:
    1. Personnel development and training
    2. Performance evaluations, coaching, and feedback
    3. Time and attendance management
    4. Employee relations and disciplinary actions
  • Lead and manage manufacturing resources to achieve production schedules and targets.
  • Coordinate and oversee projects related to aseptic filling, formulation, and cleaning processes, including defining project scopes, identifying resources, and scheduling.
  • Act as the primary liaison among Production, Facilities, Engineering, Validation, Technical Services, Quality Assurance, and Supply Chain to manage and monitor manufacturing processes and quality standards.
  • Develop and track key performance indicators (KPIs) specific to the aseptic filling and formulation areas.
  • Identify and implement continuous process improvements within the manufacturing environment.
  • Create and update Standard Operating Procedures (SOPs) for new and existing equipment/processes.
  • Ensure that employee training on SOPs and processes is up-to-date.
  • Maintain necessary qualifications and ensure proper scheduling.
  • Analyze production efficiencies, focusing on downtime and waste, and lead initiatives to enhance outcomes.
  • Draft and review investigations and corrective actions for departmental non-conformances, collaborating with Quality Assurance to resolve issues promptly.
  • Manage staffing levels and budgetary allocations.

Qualifications and Skills:

  • A minimum of 5 years of supervisory experience in a cGMP FDA-regulated pharmaceutical manufacturing environment; 2 or more years in aseptic processing preferred.
  • Familiarity with cGMP guidelines and standards.
  • A Bachelor’s degree or equivalent experience in Biology, Chemistry, Microbiology, or a related field is preferred.
  • Lean Six Sigma training, Green Belt or Black Belt certification is a plus.
  • Strong written and verbal communication skills, including effective presentation abilities.
  • Comprehensive knowledge of process equipment, unit operations, and safety protocols; hands-on skills are essential.
  • Self-motivated, highly organized, and detail-oriented with strong interpersonal skills for effective collaboration.
  • Ability to work independently and as part of a team, adapting to change in a fast-paced environment.
  • Proficiency in Microsoft Office, particularly in spreadsheets and word processing.

Benefits:

  • Comprehensive employer-paid medical plan.
  • Dental and vision insurance options, including FSA and HSA.
  • Employer-paid life insurance and employee assistance programs.
  • Short-term and long-term disability insurance.
  • 401K matching up to 4% (100% vested from day one).
  • Generous paid time off policies, including vacation, sick leave, and holidays.
  • Annual tuition reimbursement of $5,250 after six 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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