Manufacturing Specialist

Aditi Consulting; Thousand Oaks (CA); On-site; USD 55,104 - 57,859; Full time

Benefits offered by this job

401(k) plan participation

Medical, dental, and vision benefits

10 paid days off

Life and disability insurance

Job summary

Aditi Consulting is seeking an NPI Lead to oversee project planning within their pharmaceutical operations. The role demands collaboration across multiple functions to ensure timely delivery of new products while adhering to regulatory standards. Candidates should have a solid understanding of drug manufacturing processes and project management skills to effectively lead cross-functional teams.

Qualifications

• Project Management experience preferred.
• Direct experience in Drug Product Manufacturing required.
• Ability to manage multiple deliverables.

Responsibilities

• Develop, maintain, and implement NPI project plans.
• Proactively lead cross-functional team meetings.
• Ensure compliance with GMP standards.

Skills

Detail oriented

Organized

Cross Functional Team Leadership

Quantitative / analytical troubleshooting skills

Job description

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This range is provided by Aditi Consulting. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$40.00/hr - $42.00/hr

Payrate: $40.00 - $42.00/hr.

Summary:
The NPI Lead is expected to have ownership over the Technology Transfer Project Planning, an activity that is vital to the impact that ATO B20 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 B20 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.

Responsibilities:

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

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 preventive 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.)

Top Must Have Skill Sets:

• Drug Product Manufacturing Experience/Pharmaceutical Product New Product Introduction Experience
• Detail orientated
• Organized
• Being able to manage multiple deliverables at the same time
• Cross Functional Team Leadership

Pay Transparency: The typical base pay for this role across the U.S. is: $40.00 - $42.00/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/privacypolicy ).

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 to 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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