MSAT Process SME II at Leiters Inc

Englewood, Colorado, United States -

Full Time

Start Date

Immediate

Expiry Date

01 Oct, 26

Salary

105000.0

Posted On

03 Jul, 26

Experience

2 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Aseptic Techniques, GMP Systems, Technical Writing, Root Cause Analysis, Process Validation, Technology Transfer, Lean Principles, Problem Solving, Risk Assessment, Microsoft 365, Change Control, CAPA Management

Industry

Pharmaceutical Manufacturing

Description

The Manufacturing, Sciences, and Technology (MS&T) 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: This description is intended to be illustrative of the major duties performed by the employee assigned to this position. * Support GMP manufacturing operation as the MS&T 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. * 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: 1. Quality Systems – Change Control (tech transfer, process improvement, emergency etc.), Deviations (complex manufacturing investigations), CAPAs (complete ownership), Action Items (management and execution) 2. Study or investigational protocols and corresponding reports 3. Process Characterization, Validation, Qualification protocols and reports. 4. Product Impact and Risk Assessments, Failure Modes Risk Analysis 5. 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: * N/A Experience and Necessary Competencies: * 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. * Experience in aseptic techniques. * 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. * 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. * 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 * Experience with analytical problem-solving tools * Basic 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 are required. * Proficiency with Microsoft 365 tools including Outlook, Microsoft, and Excel. Physical Requirements: * Ability to stand or sit for extended periods of time. * Ability to lift, push and pull up to 50 pounds periodically. * Ability to maintain a gowning qualification, if applicable. Benefits: * Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!) * FSA & HSA available * Dental & Vision insurance options * 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.

Responsibilities

The MSAT Process SME supports GMP manufacturing operations by resolving process issues and implementing efficiency improvements for formulation, aseptic filling, and packaging. They are responsible for authoring quality documentation, managing technology transfers, and conducting root cause investigations for non-conformances.