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Title21 Health Solutions, a leading provider of Health and Life Science data management solutions, is seeking a Manufacturing Execution System Consultant II to join the Title21 Team in their mission to advance the promise of novel Cellular and Genetic Therapies. This position seeks candidates who have a strong background in Stem Cell Transplant or Cellular/Gene Therapy Product/Process Development and Manufacturing, coupled with a strong background in Information Technology and/or Informatics. This position is charged with providing domain and technical expertise, guidance, and direction to the Title21 teams responsible for the successful implementation and development of our Cell Processing and Manufacturing Software systems. The ideal candidate has extensive experience working in Stem Cell/BMT labs or IND product/process development labs and has a passion for leading the development of software technologies to deliver on their promise of improved product manufacturing, quality, and patient outcomes. The candidate will have a career track record of progressive accomplishment in the cellular processing/manufacturing space in addition to a solid technology background.

Required Experience

Relevant work experience in one or more of the following areas

o 5+ years BMT Lab Technologist

o 5+ years in IND (Pre-clinical, Phase I, II, III, or commercial) process/product develop in novel Cellular or Gene Therapy products.

o 5+ years of Process Development experience in academic, CDMO/CMO or cGMP facility in Cellular, Regenerative or Immunotherapy product development and manufacturing.

3+ years experience working technology platforms and systems, including database or informatic systems, analytics and reporting, or other process-based biologic/biopharma manufacturing systems (e.g. Manufacturing Execution Systems, ERP, etc.).

o Candidates who have participated in the implementation of these systems, compared with a user role only, are preferred.

Strong understanding and familiarity with supporting systems, as applicable to the cell processing (and/or cGMP setting), such Raw Materials and Equipment Management, Labeling (including ISBT 128), QC/Labs, and Finished Product Inventory Management.

Strong understanding of lab or cell manufacturing processes, including experience with open processing and closed processing systems.

Strong understanding and familiarity with regulations and standards including, FDA (21CFR Part 11, GxPs, PHS Act), EMEA, GAMP 5, FACT, etc.

Responsibilities

Provide domain and technical support and leadership in the implementation of Title21 Manufacturing Execution Systems, requiring expertise in process development and product processing, product calculations, batch record reviews, documentation, COAs, QC/Labs and similar.

Provide technical support and leadership in the development of the Title21 MES platform.

Provide technical guidance for the development of validation plans and approaches for both software development and customer implementations to ensure quality of data and integrity.

Assist the Business Development Team with technical expertise in presenting Title21 solutions.

Develop and present case studies and other similar presentations to academia and industry in the successful implementation of technology to solve current challenges and facilitate new opportunities.

Minimum Required Soft Skill Set

Strong technical skills and familiarity with software technology

Demonstrated ability to learn quickly and add value immediately in a fast-paced environment.

Demonstrated ability to work as both a team member and as an individual contributor.

Excellent time management skills.

Excellent verbal, public speaking, and written communication skills. Ability to effectively document results.

Demonstrated ability to deliver clear, concise instructions, communicate difficult concepts simply and effectively, and maintain professional presentation skills.

Highly detailed oriented with extremely good follow-up.

Excellent interpersonal skills

Strong initiative and ability to thrive in self-directed work teams.

Strong critical thinker with the ability to learn new systems, synthesize information and formulate recommendations.

Personal Traits

Ability to work independently and self-starting.

Enjoy working on a team with enthusiastic, talented professionals; being a team player and enjoying a collaborative environment is essential.

Ability to be agile in a high growth, fast-paced environment.

Willingness to learn, grow and take on more responsibilities.

Desire to learn the Title21 software systems.

Self-starter, reliable, conscientious, customer-focused team member.

Requirements

Education Requirements

Minimum BS 4-year degree in health or life sciences. Masters in health or life sciences discipline is preferred.

Position Type

Full-Time Employment; Non-Exempt

Travel

Potential; approximately 15%

Location

This position is located in Phoenix, AZ.

Benefits

Title21 Health Solutions provides a competitive compensation and benefits package including:

Medical Plan/Dental/Vision plan

401(k) with company match

Paid Holiday/Vacation/Birthday/Personal-Sick days

Life/Disability Insurance Plan

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