Manufacturing Science & Technology SME I

The Process SME reports to the Manager of MSAT. They act as a Subject Matter Expert for pharmaceutical manufacturing processes including technical transfer, leading, planning, and execution of technology and process innovation that aligns with the Strategic Plan. They exemplify appropriate industry standards (cGMP/GDP). Projects and initiatives may vary, and include things such as authoring and executing protocols and reports to support engineering studies or validation activities; new product/process introduction, process re-design, and process improvement projects; project management; manufacturing troubleshooting; investigating deviations and executing corrective and preventive actions; etc. 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 MSAT Process SME and point of contact. Provide rapid response to manufacturing issues and use problem solving techniques to quickly resolve issues. Assist with the investigation process for non-conformances to determine root cause by following a problem-solving methodologyAssists more senior team members with validation and qualification activities (examples may include writing protocols for non-complex equipment and processes, executing protocols in part or in whole, and writing reports).Implement Corrective and Preventive actions on the manufacturing floorReal time review equipment parameters during processing on the floor and anticipate risk of deviationAuthor 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 reportsProcess Characterization, Validation, Qualification protocols and reports.Product Impact and Risk Assessments, Failure Modes Risk AnalysisSOPs, MSAT MBRs, FRMs, JAsManage 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: Bachelor’s degree in the sciences and/or equivalent experience required. Exposure to the pharmaceutical or other FDA regulated industries preferred. Strong curiosity and willingness to learn, along with the tenacity and drive to see projects through.Willingness to support tasks outside normal job description, as needed. Can-do attitude! Ability to create technical and professional documents.Strong attention to detail and accuracy. Ability to multi-task, with strong organization and time-management. Ability to work under pressure and independently with the ability to make decisions according to established guidelines and accomplish tasks accurately and on a timely basis.Understanding of 503B regulatory requirements, cGMP standards, and USP guidelines is a plus!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 25 pounds periodically. Benefits: Smart healthcare coverage options that rewards wellness (and puts money back in your pocket!)Flexible Spending & Health Savings Accounts (FSA & HSA) availableDental & Vision insurance Employer Paid Life Insurance & Employee Assistance ProgramShort Term & Long-Term Disability InsuranceUp 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 limitEligible 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. #leitersjobs