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Planet Pharma
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https://www.planet-pharma.com
https://www.planet-pharma.com
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Specialist Manufacturing
Posted: 06/03/2025
2025-06-03
2025-07-12
Employment Type:
Contract
Job Category: Engineering
Job Number: 619740
Is job remote?: No
Country: United States
Job Description
Target PR Range: 34-44/hr
*Depending on experience
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Role: Specialist Manufacturing, New Product Introduction
Let’s do this! At we strive to serve every patient, every time.
In this critical role for the Drug Product (DP) facility - you will be responsible for the introduction of new products into the manufacturing plant. This “Specialist Manufacturing” role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that with a clinical and commercial product mix has to the network. This role will function as a vital interface between the 5 key functions that enable the plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.
Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.
The NPI Lead will be primarily responsible for:
• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
Additional Responsibilities include:
• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.
Basic Qualifications:
• Master’s degree in Engineering, Biology, Chemistry or Life Science Field
• Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field & 2 years of directly-related GMP manufacturing experience OR
• Associate’s degree & 4 years of directly-related GMP manufacturing experience OR
• High school diploma / GED & 8 years of directly-related GMP manufacturing experience.
Preferred Qualifications:
• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)
*Depending on experience
You’ve worked hard to become the professional you are today and are now ready to take the next step in your career. How will you put your skills, experience and passion to work toward your goals? our shared mission—to serve patients—drives all that we do. It is key to our becoming one of the world’s leading biotechnology companies, reaching over 10 million patients worldwide. Come do your best work alongside other innovative, driven professionals in this meaningful role.
Role: Specialist Manufacturing, New Product Introduction
Let’s do this! At we strive to serve every patient, every time.
In this critical role for the Drug Product (DP) facility - you will be responsible for the introduction of new products into the manufacturing plant. This “Specialist Manufacturing” role will serve as a New Product Introduction Lead within the New Product Introduction, Manufacturing Execution Systems, and Digital team
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that with a clinical and commercial product mix has to the network. This role will function as a vital interface between the 5 key functions that enable the plant to add value to the network: Manufacturing, Process Development, Supply Chain, Quality, and Facilities & Engineering. A high degree of interactions and collaboration is required across these groups, and the NPI Lead needs to be able to understand their business and manufacturing processes with enough confidence to drive decision-making and impose timelines.
Candidates will need to demonstrate knowledge of DP technical process, manufacturing operations, scientific method, basic regulatory compliance expectations, and quantitative / analytical troubleshooting skills. The NPI Lead will be responsible for leading cross-functional projects to deliver NPIs on time through effective indirect people management and effective communication, both within and outside of the immediate team.
The NPI Lead will be primarily responsible for:
• Working with NPI support groups to develop, maintain, and implement the NPI project plan(s), being accountable for NPI scope, schedule, risk management, and leading matrixed teams through influence to meet NPI project milestones.
• Resolving issues in a timely manner and elevating cross-functional customer concern to various levels of management as appropriate.
• Owning Change Controls in Trackwise, ensuring records are comprehensive and compliant per GMP regulatory procedures. This must occur through a Right-First-Time approach.
• Proactively leading cross-functional team meetings, to ensure NPI project(s) and other relevant business cases execute per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
Additional Responsibilities include:
• Engaging with Quality and Regulatory teams to ensure alignment and compliance across the network and with various agency submissions while delivering NPI project(s).
• Holding supporting functions accountable for delivery of NPI project tasks through documentation of Lessons Learned and presentation to management when appropriate.
• Reviewing protocols for manufacturing activities and partnering with Quality Assurance to ensure that GMP standards are maintained in line with current SOPs, batch record documentation, and licenses.
• Identifying improvement opportunities within the organization and taking proactive steps to build consensus to implement those opportunities.
• Performing purposeful presence Gemba walks in the manufacturing plant to identify process improvement opportunities as pertaining to NPIs and relevant lifecycle management strategies.
• Reporting on team and plant metrics to ensure visibility to team operations and deliverables.
• Representing the team at plant-wide and network-wide forums, as needed.
Basic Qualifications:
• Master’s degree in Engineering, Biology, Chemistry or Life Science Field
• Bachelor’s degree in Engineering, Biology, Chemistry or Life Science Field & 2 years of directly-related GMP manufacturing experience OR
• Associate’s degree & 4 years of directly-related GMP manufacturing experience OR
• High school diploma / GED & 8 years of directly-related GMP manufacturing experience.
Preferred Qualifications:
• Project Management experience
• Direct and/or indirect people management / leadership experience
• Understanding of Drug Product Formulation and Vial/Syringe Filling operations
• Experience with various quality systems including change control, deviations, corrective and preventative actions, and/or validation practices
• Strong organization and technical writing skills; able to articulate complex problems concisely with technical and management staff
• Independent, self-motivated, able to multi-task in a fast-paced environment
• Team-player
• Demonstrated flexibility and ability to manage change
• Direct experience with regulated environments (e.g., cGMP etc.)
The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.
Planet Pharma is an equal opportunity employer. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.
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