What are the responsibilities and job description for the MSAT Process SME III position at Leiters Inc?

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.

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