Aditi Consulting is hiring: Specialist Manufacturing in Thousand Oaks

1 week ago Be among the first 25 applicants

Payrate: $35.60 - $40.96/hr.

Summary:
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.

Responsibilities:

• 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.
• 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 Track wise, 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 by per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
  
  

Payrate: $35.60 - $40.96/hr.

Summary:
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.

Responsibilities:

• 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.
• 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 Track wise, 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 by per schedule.
• Succinctly communicating verbally, in writing, and through presentations to peers and senior leadership team.
  
  

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.)

Must Have Skill:

• Drug Product Manufacturing Experience/Pharmaceutical Product New Product Introduction Experience

Pay Transparency: The typical base pay for this role across the U.S. is: $35.60 - $40.96/hr. Final offer amounts, within the base pay set forth above, are determined by factors including your relevant skills, education and experience and the benefits package you select. Full-time employees are eligible to select from different benefits packages. Packages may include medical, dental, and vision benefits, 10 paid days off, 401(k) plan participation, commuter benefits and life and disability insurance.

For information about our collection, use, and disclosure of applicant's personal information as well as applicants' rights over their personal information, please see our Privacy Policy (https://www.aditiconsulting.com/privacy-policy).

Aditi Consulting LLC uses AI technology to engage candidates during the sourcing process. AI technology is used to gather data only and does not replace human-based decision making in employment decisions. By applying for this position, you agree to Aditi’s use of AI technology, including calls from an AI Voice Recruiter.

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Management and Manufacturing

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