Talent.com
MSAT Process SME III
MSAT Process SME IIILeiters Inc • Englewood, CO, US
MSAT Process SME III

MSAT Process SME III

Leiters Inc • Englewood, CO, US
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Description

Job Description

Manufacturing Science & Technology (MSAT) Process SME III

The Manufacturing, Sciences, and Technology (MSAT) Process SME will support GMP manufacturing operations. A Process SME is actively engaged with the manufacturing team in resolving process related issues, developing efficiency improvements, authoring GDP documentation, and providing immediate problem resolution, in collaboration with quality assurance or a cross functional team, to ensure schedule adherence. The individual will serve as a subject matter expert (SME) for Formulation, Aseptic Filling, and Packaging Processes. Success in this position requires the ability to work hands-on in a cleanroom environment and the ability to collaborate in a cross-functional, fast-paced environment.

Why Join Leiters Health?

Are you passionate about making a real impact in the pharmaceutical industry? Do you thrive in a collaborative, innovative environment where your skills and ideas are valued? Look no further – Leiters Health is seeking talented individuals like you to join our dynamic team!

At Leiters Health, we're not just another pharmaceutical company – we're pioneers in the field, dedicated to delivering high-quality compounded sterile products and outsourced solutions to healthcare providers nationwide. Our commitment to excellence and patient safety is at the core of everything we do.

  • Innovative Culture : Be part of a forward-thinking company that encourages creativity, welcomes fresh ideas, and fosters an environment of continuous improvement.
  • Meaningful Work : Contribute to a purpose-driven organization dedicated to providing critical medications and healthcare solutions that positively impact patients' lives.
  • Professional Development : Access ongoing training, mentorship, and growth opportunities to expand your skills and advance your career within a rapidly growing industry.
  • Cutting-Edge Technology : Work with state-of-the-art facilities and advanced technologies, staying ahead of the curve in pharmaceutical manufacturing.
  • Collaborative Environment : Join a team of passionate individuals who are dedicated to teamwork, support, and mutual success, fostering a culture of inclusivity and collaboration.

Who We're Looking For :

We're seeking enthusiastic individuals who are driven, adaptable, and passionate about contributing to a mission-driven organization. Whether you're an experienced professional or just starting your career, Leiters Health provides an environment where your skills and talents will be recognized and appreciated. Sound like you? Apply today!

Essential Functions :

  • Support GMP manufacturing operation as the MSAT Process SME and point of contact.
  • Provide rapid response to manufacturing issues and use problem solving techniques to quickly resolve issues.
  • Serve as team liaison for process and product investigations and author investigation reports.
  • Participate in manufacturing daily Tier meetings and closely follow manufacturing schedule to identify critical process steps where priority support is needed.
  • Participate in Deviation triage by providing recommendations and immediate path forward in conjunction with QA.
  • Investigate process non-conformances to determine root cause by following a problem-solving methodology
  • Implement Corrective and Preventive actions on the manufacturing floor
  • Real time review equipment parameters during processing on the floor and anticipate risk of deviation
  • Author and own / manage the following documentation :
  • Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution)

  • Study or investigational protocols and corresponding reports
  • Process Characterization, Validation, Qualification protocols and reports.
  • Product Impact and Risk Assessments, Failure Modes Risk Analysis
  • SOPs, COPs, MSAT MBRs
  • Manage and own Technology Transfer campaigns for new product introductions, and process improvements to manufacturing processes.
  • Provide hands-on manufacturing process training to manufacturing personnel as part of process tech transfer in suite as needed.
  • Other duties as assigned.
  • Supervisory Responsibilities :

  • None
  • Experience and Necessary Skills :

  • B.S degree required in Chemical Engineering, Chemistry, Industrial Engineering, Biochemistry or a related field, or equivalent industry experience. Master’s degree preferred.
  • A minimum of 3 years of relevant hands-on operations experience for commercial production in the life sciences industry.
  • Expertise in aseptic technique.
  • Knowledge and understanding of GMP systems and FDA regulations within a manufacturing facility.
  • Ability to organize, analyze manufacturing process data, and provide potential process improvements.
  • Knowledge and expertise in manufacturing process tech transfer.
  • Excellent oral and written communication skills. Strong technical writing ability required.
  • Ability to work cross functionally within the organization as part of a project team.
  • Strong technical skills with an emphasis on applying the needs of end-users to manufacturing processes
  • Strong collaborative skills with an emphasis on seeking advice and gaining the consensus of subject matter experts
  • Strong analytical problem-solving skills to support technical transfer of new products
  • Strong understanding of Lean Principles
  • Self-motivated and willing to accept temporary responsibilities outside of initial job description.
  • Must be comfortable in a fast-paced small company environment and able to adjust workload based upon changing priorities.
  • Proficient written, verbal and oral English communication skills.
  • Benefits :

  • 100% employer paid medical plan.
  • Dental & Vision insurance options including FSA & HSA
  • Employer Paid Life Insurance & Employee Assistance Program
  • Short Term & Long-Term Disability Insurance
  • Up to 4% 401K Matching (100% vested on day one!)
  • Generous Paid Time Off Options – vacation, sick, paid leave and holidays!
  • $5,250 Annual Tuition Reimbursement after 6 months
  • $1,000 Referral Bonus Program with no limit
  • Eligible for annual bonus program
  • Timeline :  We will be accepting applications on an ongoing basis until position is filled.

    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.

  • Please note that we do not work with third-party recruiters or agencies for this position. If you are a qualified candidate and wish to apply for this job, please do so directly through our official application process. We appreciate your understanding and cooperation in this matter.
  • serp_jobs.job_alerts.create_a_job

    Sme • Englewood, CO, US

    Job_description.internal_linking.related_jobs
    Travel Speech Language Pathologist

    Travel Speech Language Pathologist

    Fusion Medical Staffing-Therapy • Elizabeth, CO, US
    serp_jobs.job_card.full_time
    Fusion Medical Staffing-Therapy is seeking a travel Speech Language Pathologist for a travel job in Elizabeth, Colorado.Job Description & Requirements. Travel Speech Language Pathologist.Facilit...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Production Technician

    Production Technician

    Golden Aluminum • Fort Lupton, CO, US
    serp_jobs.job_card.full_time
    We are a continuous casting aluminum rolling mill who established operations in 1984 and located in Fort Lupton Colorado, 35 miles north of downtown Denver. We care about our environment, our people...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of IVD Assay Development

    Director of IVD Assay Development

    VirtualVocations • Boulder, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, IVD Assay Development.Key Responsibilities Lead the design and execution of development studies for colorectal cancer tests Oversee Analytical Validation (AV...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Process Analyst

    Senior Process Analyst

    VirtualVocations • Aurora, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Process Analyst to join their dynamic team in the Process Optimization Department.Key Responsibilities Facilitate process meetings to gather insights and drive i...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Delivery Driver

    Delivery Driver

    DoorDash • Elizabeth, CO, United States
    serp_jobs.job_card.full_time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Business Process Analyst

    Business Process Analyst

    VirtualVocations • Aurora, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Business Process Analyst to optimize and transform mission operations for a federal client.Key Responsibilities Analyze and map existing business processes to identify ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Delivery Driver - Flexible Schedule

    Delivery Driver - Flexible Schedule

    DoorDash • Elizabeth, CO, United States
    serp_jobs.job_card.full_time +1
    DoorDash is the #1 category leader in food delivery, food pickup, and convenience store delivery in the US, trusted by millions of customers every day. As a Dasher, you’ll stay busy with a variety o...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Test Instrumentation Technician : Intermediate

    Test Instrumentation Technician : Intermediate

    Lockheed Martin • Roxborough, CO, US
    serp_jobs.job_card.full_time
    The coolest jobs on this planet.Lockheed Martin is a pioneer, partner, innovator and builder.Our amazing people are on a mission to make a difference in the world and every single day we use our sk...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Scientist 1

    Scientist 1

    Pace Analytical Services • Golden, Colorado, United States of America
    serp_jobs.job_card.full_time
    Monday through Friday, 8 : 00 AM - 5 : 00 PM.Are you ready to work making the world a safer, healthier place? Join our mission to continuously move science forward. to innovate and advance all aspects ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Forklift Mechanic

    Forklift Mechanic

    Golden Aluminum • Fort Lupton, CO, US
    serp_jobs.job_card.full_time
    We are a continuous casting aluminum rolling mill who established operations in 1984 and is located in Fort Lupton Colorado, 35 miles north of downtown Denver. We are the proud owner of a patented c...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Federal Healthcare Program SME

    Federal Healthcare Program SME

    VirtualVocations • Aurora, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Federal Healthcare Program Subject Matter Expert (SME).Key Responsibilities Acts as a government healthcare business advisor and liaison to the Government and contracte...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr. Spacecraft Assembly, Integration & Test Engineer (Will Consider All Senior Levels)

    Sr. Spacecraft Assembly, Integration & Test Engineer (Will Consider All Senior Levels)

    Redwire Space • Littleton, CO, United States
    serp_jobs.job_card.permanent
    Redwire is accelerating humanity's expansion into space by delivering reliable, economical, and sustainable infrastructure for future generations. Redwire Space Missions, is accelerating humanity's ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    SOAR Consultant with XSIAM

    SOAR Consultant with XSIAM

    VirtualVocations • Boulder, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a SOAR Expert with XSIAM for a remote position.Key Responsibilities Manage SIEM technology, ticketing systems, log sourcing, and data source integration Deliver technica...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director of Process Improvement

    Director of Process Improvement

    VirtualVocations • Boulder, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Process Owner to support the return mail process.Key Responsibilities Support strategy for complex business transformational priorities Provide oversight for...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Lead Quality Engineer

    Lead Quality Engineer

    Loft Orbital Solutions • Golden, CO, US
    serp_jobs.job_card.full_time
    Loft is seeking a detail-oriented, systems-minded.This role provides an opportunity to guide quality practices and act as a subject matter expert across multiple programs.The Lead Quality Engineer ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Business Process Specialist

    Business Process Specialist

    VirtualVocations • Boulder, Colorado, United States
    serp_jobs.job_card.full_time
    A company is looking for a Business Process Subject Matter Specialist (ECWM).Key Responsibilities Serve as the primary business process expert and technical advisor for DoD contracting operations...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Certified Occupational Therapist Assistant

    Certified Occupational Therapist Assistant

    Cherrelyn Healthcare Center • Franktown, CO, US
    serp_jobs.job_card.full_time
    Please note before applying for this position, you must hold an active license to treat in Occupational Therapy in addition to any other degrees or certifications. The Certified Occupational Therapi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_hour • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Manufacturing Technician I - 8 : 00am to 4 : 30pm,

    Manufacturing Technician I - 8 : 00am to 4 : 30pm,

    Integrated DNA Technologies (IDT) • Boulder, Colorado, United States of America
    serp_jobs.job_card.full_time
    Are you ready to accelerate your potential and make a real difference within life sciences, diagnostics and biotechnology?. At Integrated DNA Technologies (IDT), one of.You’ll thrive in a culture of...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted