Product Manager

Title21 Health Solutions, a leading provider of Health and Life Science data management solutions, is seeking a Product Manager II to join the Title21 Team in their mission to advance Cellular Therapies and Enterprise Quality Management Systems (EQMS). This position seeks candidates who have a strong background in Product Management focused on the Health and Life science domains and is charged with providing domain and product expertise to the Title21 teams responsible for the successful product development of our Cell Processing/Manufacturing Software and EQMS systems. The ideal candidate has extensive experience managing a product portfolio 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 Product Management in the cellular processing/manufacturing and/or EQMS space, in addition to a solid technology background.

Required Experience

Relevant work experience, in the Health and Life Sciences, in one or more of the following areas

o 5 - 10 years as Product Manager developing Manufacturing Execution Systems or similar.• Strong understanding of lab or cell manufacturing processes, including experience with open processing and closed processing systems.• 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.

o 5 - 10 years as Product Manager developing EQMS• Strong understanding and familiarity with Health and Life Science EQMS, including Document Control, LMS, Error Management, Audit, etc.

Experience working in

o Agile development frameworks

o Using Product Management and Development toolsets

o DevOps

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

o Strong understanding of Software Validation in the GMP/GAMP5 frameworks.

Requirements

Responsibilities

Provide domain and technical support and leadership in managing Product Development of Title21 Manufacturing Execution Systems and/or EQMS, including working with external development teams.

Serve as the "Voice of the customer", working with customers to specify, document and beta new and improved features.

Plan Builds, Releases, timetables, and maintain Product Backlogs.

Develop and maintain Product Requirements Documentation.

Develop of Product Release notes and supporting documentation.

Participate in Customer Training.

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

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.

Education Requirements

Minimum BS 4-year degree in health or life sciences. Master's 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