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Applications Manager, Manufacturing and Operations

Cook MyoSite

This is a Full-time position in Pittsburgh, PA posted February 21, 2021.

nn Overview nn nn n nn nnCook MyoSite, Inc.

is on a mission to make regenerative medicine a part of everyday medicine.

We’re investigating our core technology, autologous muscle-derived cells, for the potential treatment of several muscle-related disorders.

We at Cook MyoSite have the potential to make a difference in the lives of countless people around the world, and we also have the potential to make a difference in yours.

Joining our team is an opportunity to ignite your passion, grow your potential, and define your purpose.

If you’re curious, motivated by helping others, and driven by integrity, we invite you to apply.nn nn nn nnThe Applications Manager, Manufacturing and Operations at Cook MyoSite, Inc.

will develop or improve, and then deliver, applications for the purpose of supporting the processes surrounding biologics manufacturing.

The Applications Manager will work with Information Systems management to establish the strategic direction for the department.nn nn n nn nn Responsibilities: nn Manage a team of professionals (system analysts, system engineers, etc.) to support the development and administration of computer systems for the company’s manufacturing and operations processes Actively participate in personnel development and ensure adequate training for personnel Establish best-practices for planning, managing, implementing, and support for systems such as ERP, LIMS, RAM, UVO, etc.

Identify opportunities for automated process improvements Identify opportunities for integration of systems to heighten data integrity Provide hardware and software evaluations and recommendations Support validation of the managed computer systems through qualification lifecycles and audits Ensure and maintain open communication with other departments for realization of department and company goals Work with executive management to align strategic objectives and priorities, and establish timelines in support of new and ongoing projects Implement change controls, SOPs, policies and procedures Work with trainers to ensure job aides and training materials accurately reflect system look, feel and functions Maintain professional and technical knowledge by attending educational workshops; reviewing professional publications; establishing personal networks; benchmarking state-of-the-art practices; participating in professional societies Must be able to work in project management format to lead projects, manage material and personnel resources, and work within a various range of project groups and initiatives nn n nn nn Qualifications: nn Bachelor’s degree in Computer Science, Information Systems, Engineering, or related technical field; or 10+ years direct, relevant experience in System Development Life Cycle to provide a comparable background Minimum of 1-3 years’ experience in managing staff for at least one of application delivery or software development.

Minimum of 3-6 years’ experience with manufacturing systems; Level I, Level II, or Level III.

Minimum of 3-6 years’ experience with packaged software tools (MATLAB, LabView, solidThinking, etc.) or programming languages (C, C++, C#, SQL, Python, Java, JS, etc.).

Knowledge of data integrity concerns and regulations Knowledge of laboratory systems is a plus Experience working with LabWare LIMS or Sage X3 ERP is a plus Experience with data integrity concerns and regulations and experience working per ISPE GAMP 5 best practices and GxP constraints preferred Basic understanding of cGMP, 21 CFR Part 11, and related regulations associated with Bio/Pharmaceutical product manufacturing preferred Experience working in a highly regulated environment (Pharmaceutical, Medical Devices, Financial) is a plus nn nn nn nn nn Physical Requirements: nn Office Setting / No Travel Ability to conduct and hear ordinary conversation and telephone communication.

Must be able to work extended hours beyond normal work schedule to include, but not limited to, evenings, weekends, extended work hours and/or extra work hours, sometimes on short notice as required.

Ability to work under specific time constraints.

Must be able to sit at desk, in meetings and/or work on a computer for long or extended periods of time.

Visual and manual acuity for working with computers and equipment.

nn n nn nn n nn nn At Cook MyoSite, we don’t just accept difference
– we celebrate it, we support it, and we thrive on it for the benefit of our nn nn employees, our products, and our community.

Cook MyoSite is proud to be an equal opportunity workplace nn nn n nn nn This posting features the essential and critical functions of the position described and is not an exhaustive list of tasks and/or nn nn responsibilities.

This may be subject to change at any time due to reasonable accommodation or other reasons.

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