100% Onsite supporting Thousand Oaks Drug Product Manufacturing Facility Standard business hours, M-F 8-5pm
PST Role:
Specialist Manufacturing, New Product Introduction Let's do this! we strive to serve every patient, every time. In this critical role for the Thousand Oaks Drug Product (DP) facility, - also known as ATO B20 - 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 at ATO B20. 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.
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.)
Salary and Other Compensation:
The annual [salary/hourly rate] for this position is between $35.00 - 38.00 per hour . Factors which may affect pay within this range may include geography/market, skills, education, experience, and other qualifications of the successful candidate.
Benefits:
The Company offers the following benefits for this position, subject to applicable eligibility requirements: [medical insurance], [dental insurance], [vision insurance], [401(k) retirement plan], [life insurance], [long-term disability insurance], [short-term disability insurance], [paid parking/public transportation], [Paid time off], [Days/hours of paid sick and safe time], [Days/hours of paid vacation time], [Weeks of paid parental leave], [Paid holidays annually], [any additional benefits applicable].
