**Are you looking for a career that matters?**
We believe every person deserves a chance for a healthy life, free from illness and full of possibility. We see a world full of healing, with viable care options available to those with limited choices today. We envision new ways of providing physicians, pharmacists and nurses with technologies that not only treat chronic diseases, but also work to prevent them. We’re looking for team members who are motivated to learn, grow and innovate, while making a meaningful difference for millions of people around the world.
Project/Process Development Specialists provide:
1) business and technical leadership for new clinical or commercial projects
2) reengineering support for internal reorganizations or integrations
3) This role involves leading key projects from the manufacturing perspective through the initiation and implementation processes. This person will will help generate pricing for clinical and commercial manufacturing, and will be the primary point of contact for the client/R&D from a manufacturing perspective during the development phase. This person will assist in the development of tools and processes to ensure consistency in the overall management and efficiency in the internal systems employed. This person collaborates with all related functions within the business.
4) This role involves serving on cross-functional teams to investigate operational/organizational/manufacturing deficiencies within the current processes in order to design improvements and implement more efficient/effective systems. This person will interact with all affected functional areas and will assist those areas in the implementation of any recommendations.
The Project/Process Development Specialist is
1) This person is responsible for overall manufacturing project implementation activities from development through commercialization and will coordinate all client requests, ensure milestones are identified and met, schedule production and shipment of product
2) Process Developer – This person is accountable for ensuring that the redesigned or reengineered process will improve the overall operations of the company and that the implementation follows the least disruptive approach.
Essential Duties and Responsibilities:
Develops requirements with process development team based on mfg capabilities, protocol development, scheduling batch time, change control tasks, regulatory support.
Ensures compliance with all GMP rules, product documentation, specifications, SOPs, and FDA requirements as required.
Performs/leads technical reviews, investigations and process improvement projects.
Provides manufacturing input into integration and validation of new equipment and processes.
Resolves technical, material and cGMP problems that may impact project deadlines. Provides guidance and troubleshooting assistance as needed during a deviation in the process.
Provides information as necessary to FDA that establishes credibility and demonstrates compliance with cGMPs.
May monitor capital expenditures and assist in developing budgets.
Participates in business cost proposals for clinical and commercial production. Identifies customer requirements for projects.
Participates in process team meetings and provides department perspective.
Technical approval on behalf of the client.
Maximizes business results through continuous improvement.
Supports process team by providing documentation support and issue resolution to eliminate or minimizes barriers to progress manufacturing development.
Identifies contentious points in proposed processes and mitigates element of surprise for affected areas.
Proven track record of interpersonal and leadership skills with ability to interface well with other departments, and lead effectively and efficiently in a team environment.
In-depth process knowledge of related manufacturing equipment and processes.
Ability to manage multiple priorities in a manufacturing plant setting.
Ability to analyze and interpret scientific, and statistical data.
Strong professional writing skills and ability to prepare technical reports. Ability to
clearly articulate information during regulatory/client inspections.
Ability to understand GMPs and other applicable regulatory guidelines.
Strong assessment and troubleshooting skills.
Ability to respond to detailed inquiries and present information to groups and senior leaders.
Computer proficiency in Microsoft Office and ability to use enterprise software.
Ability to collect and analyze data and information to determine paths for process improvement and potential root cause
Demonstrated critical thinking and problem-solving skills.
Working knowledge of manufacturing business acumen and lean, six sigma manufacturing methods.
Education and/or Experience:
Bachelor’s degree required.
5 years manufacturing experience and 3 years of supervisory experience.
**Equal Employment Opportunity**
Baxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, protected veteran status, disability/handicap status or any other legally protected characteristic.
EEO is the Law at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/eeopost.pdf
EEO is the law – Poster Supplement at http://www.dol.gov/ofccp/regs/compliance/posters/pdf/OFCCP_EEO_Supplement_Final_JRF_QA_508c.pdf
Pay Transparency Policy at https://www.dol.gov/ofccp/pdf/pay-transp_%20English_formattedESQA508c.pdf
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.
Our products and therapies touch the lives of millions of people around the world every day, which is why we are focused on transformative innovations that bring smarter, more personalized care to all of us. For 87 years and counting, we have been at the critical intersection where the ideas that save and sustain lives meet the providers who make it all happen. And now, we are determined to realize our boldest opportunities to transform global healthcare for years to come.