RTI Surgical®
Research and Development Manager- Design Transfer
RTI Surgical®, West Lafayette, Indiana, United States, 47907
While this is intended to accurately reflect the current job, it is not necessarily an exhaustive list of all responsibilities, skills, duties, requirements, or working conditions associated with the job. RTI Surgical, Inc., reserves the right to revise the job or require that other or different tasks are performed when circumstances warrant (i.e., emergencies, changes in personnel or staffing, workload, or technical developments).
COMPANY SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana; Eden Prairie, Minnesota; Glencoe, Minnesota and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:• Accountable: We own our actions and decisions.• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.• Growth Mindset: We embrace challenges as opportunities for continuous learning.• Customer-Centric: We prioritize customers at every touch point.• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Primary Function:The person in this position is responsible for leading process development activities for early-stage development projects and, as needed, contributing to transfer to manufacturing activities for the same or other projects. This position is responsible for coordinating resources necessary to drive completion of work.
Essential Job Function/Duties
Personnel
Provide direction to team members about daily tasks and longer-term goals related to company strategy and project completion.Collaborate to set process development priorities based on company needs.Communicate resource needs to other managers as well as directors and company officers.Conduct performance appraisals and wage reviews for direct reports.Depending on the outcome of resource need discussions, hire additional team members.Processes
Manage the process of completing process development projects.Establish metrics to measure performance and output of process development work.Provide input on and help drive continuous improvement of key process engineering responsibilities including project management, risk analysis, and process development.Provide excellent customer service to internal and external customers.Ensure timely development of product specifications for new or evolving products.Review and pre-approve change requests.Participate in change control committee (CCC) meetings.Participate in process risk analysis meetings (RCG and RCCC).Communication
Maintain excellent communication with internal and external customers regarding project progress and technical details.Understand available data related to process development projects and use the information to drive conversations about specification development and manufacturability.Ensure direct reports are well-informed about company information, events, priorities, processes, and changes.Work with other CBI employees to ensure good communication channels exist and remain between engineering and other areas.Other
Assist with managing relevant departmental budget tracking and adherence.Remain current and apply the understanding of relevant controlling regulations cited in the Quality System Manual in carrying out job responsibilities.Conduct other corporate duties when required.Administer and ensure compliance to the Cook Biotech andOSHA/IOSHA requirements for Hazard Communication.Minimum Work Experience/Educational Requirements
BS in engineering or related field, or equivalent experienceAt least five (5) years previous experience in a technical and manufacturing environmentExperience in medical device or pharmaceutical manufacturing preferredExperience in previous management role(s) preferred.Able to set goals for self and others.Interest in achieving milestones in a timely manner.Able to effectively listen to ideas and concerns coming fromOthers
Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals.Proven project management skills and the ability to work on multiple projects simultaneously and help others do the same.Able to effectively listen to ideas and concerns coming from others.Able to operate statistical software such as JMP and understand basic statistics.Excellent written, verbal, and record keeping skills.Willing to work with material derived from animal tissues.Physical Requirements/Work Environment
Must be able to perform the essential functions of the job.Limited exposure to hazardous chemicals used in the manufacture of the product.Physical demands are typical of an of office similar to a classroom.
COMPANY SUMMARY:
RTI Surgical (RTI) is a global industry-leading contract development and manufacturing organization (CDMO) in regenerative medicine. As the only regenerative medicine company that offers a differentiated portfolio of allograft and xenograft biomaterials at scale, RTI provides customers across a diverse set of market segments with leading-edge expertise, scale, and flexibility across end-to-end services including design, development, regulatory support, verification and validation, manufacturing, and supply chain management. RTI is headquartered in Alachua, FL, and has manufacturing facilities in West Lafayette, Indiana; Eden Prairie, Minnesota; Glencoe, Minnesota and Neunkirchen, Germany.
RTI is rooted in a steadfast commitment to quality, integrity, and patient safety with a focus on five key values:• Accountable: We own our actions and decisions.• Agile: We embrace change to stay ahead of the curve and evolve to drive innovation and growth.• Growth Mindset: We embrace challenges as opportunities for continuous learning.• Customer-Centric: We prioritize customers at every touch point.• Inclusive: We thrive on the richness of our diversity and ensure every voice is heard, respected, and celebrated.
At RTI Surgical, we are committed to fostering an inclusive workplace where we embrace the richness of our diversity and ensure that every voice is heard, respected, and celebrated. We believe that by embracing diversity and promoting inclusivity, we not only uphold our values but also strengthen our position as the CDMO of Choice in regenerative medicine solutions. We recognize that cultivating a growth mindset is essential to our success, and we are dedicated to continuous learning and improvement in our diversity, equity, and inclusion efforts. Through accountability and action, we strive to create an environment where individuals can thrive, innovate, and contribute their unique perspectives to drive our collective success.
Montagu Private Equity ("Montagu"), a leading European private equity firm, acquired RTI in 2020 and has supported the transformation of the company to its next level of potential.
Primary Function:The person in this position is responsible for leading process development activities for early-stage development projects and, as needed, contributing to transfer to manufacturing activities for the same or other projects. This position is responsible for coordinating resources necessary to drive completion of work.
Essential Job Function/Duties
Personnel
Provide direction to team members about daily tasks and longer-term goals related to company strategy and project completion.Collaborate to set process development priorities based on company needs.Communicate resource needs to other managers as well as directors and company officers.Conduct performance appraisals and wage reviews for direct reports.Depending on the outcome of resource need discussions, hire additional team members.Processes
Manage the process of completing process development projects.Establish metrics to measure performance and output of process development work.Provide input on and help drive continuous improvement of key process engineering responsibilities including project management, risk analysis, and process development.Provide excellent customer service to internal and external customers.Ensure timely development of product specifications for new or evolving products.Review and pre-approve change requests.Participate in change control committee (CCC) meetings.Participate in process risk analysis meetings (RCG and RCCC).Communication
Maintain excellent communication with internal and external customers regarding project progress and technical details.Understand available data related to process development projects and use the information to drive conversations about specification development and manufacturability.Ensure direct reports are well-informed about company information, events, priorities, processes, and changes.Work with other CBI employees to ensure good communication channels exist and remain between engineering and other areas.Other
Assist with managing relevant departmental budget tracking and adherence.Remain current and apply the understanding of relevant controlling regulations cited in the Quality System Manual in carrying out job responsibilities.Conduct other corporate duties when required.Administer and ensure compliance to the Cook Biotech andOSHA/IOSHA requirements for Hazard Communication.Minimum Work Experience/Educational Requirements
BS in engineering or related field, or equivalent experienceAt least five (5) years previous experience in a technical and manufacturing environmentExperience in medical device or pharmaceutical manufacturing preferredExperience in previous management role(s) preferred.Able to set goals for self and others.Interest in achieving milestones in a timely manner.Able to effectively listen to ideas and concerns coming fromOthers
Proven ability to communicate and work constructively with colleagues to establish and achieve mutual goals.Proven project management skills and the ability to work on multiple projects simultaneously and help others do the same.Able to effectively listen to ideas and concerns coming from others.Able to operate statistical software such as JMP and understand basic statistics.Excellent written, verbal, and record keeping skills.Willing to work with material derived from animal tissues.Physical Requirements/Work Environment
Must be able to perform the essential functions of the job.Limited exposure to hazardous chemicals used in the manufacture of the product.Physical demands are typical of an of office similar to a classroom.