Senior Manager Operations

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Job Description:

The Lenti Viral Vector Facility produces lentiviral vector which is used in CAR-T treatments for e.g. multiple myeloma and B-cell lymphoma. The job holder is as a people manager accountable for running the manufacturing according to the production schedule and long-term production capacity in compliance with EHSS cGMP regulations requirements.

General summary

The job holder is accountable for ensuring a seamless ramp up of the existing Lenti Viral Vector manufacturing site at the Sassenheim location (Advanced Therapies) to full capacity. The job holder is accountable for hiring training and qualifying of all staff and in-time availability of all relevant operational documentation in compliance with EHSS cGMP regulations requirements.

The job holder is accountable for ensuring a seamless rampup of the existing Lenti Viral Vector manufacturing site at the Sassenheim location (Advanced Therapies) to full capacity. The job holder is accountable for hiring training and qualifying of all staff and in-time availability of all relevant operational documentation in compliance with EHSS cGMP regulations requirements.

Responsibilities:

The area of responsibility of the job holder covers the project phase including the delivery of the PPQ batches.

In this position the successful candidate will be accountable

• Deliver manufacturability / operational input for the ramp up and continuous manufacturing.

• Deliver change control strategy for operations.

• Deliver documentation strategy and execution for operations ramp up.

• Lead and coordinate the operation model for reliable delivery of batches.

• Ensure Operators are accurately trained to be able to execute their tasks.

• Ensure relevant documentation is approved to support manufacturing.

• Ensure all disposables and raw materials are qualified.

• Ensure all production areas are GMP certified.

• Develop Advanced Therapies long term strategy for Sassenheim.

• Maintain the budget and headcount model and CIP for operations.

• Builds and maintains a solid network within JBV with other J&J sites and external parties such as regulatory agencies contractors partners and vendors as needed.

• Ensures best practice sharing across JBV and J&J sites.

• Acts as delegate of the site head..

The successful candidates for a safe and sustainable work environment.

Is a Credo champion in the way the job is institutionalized and a role model of leadership. Makes the team aware of unsafe situations to prevent accidents to happen. Follow through of incident management.

Accountable for first or second line (depending on the defined department) assessment of process operation according set standards as EHSS / cGMP/ internal guidance.

During the shop floor walk downs (GEMBA) alert to any potential compliance gap. Is accountable to initiate / manage follow through. Processes are routinely assessed against standardized work and improvements systems are managed.

Accountable for people development through process excellence training green belt sponsorship CI / BI initiatives and A3 thinking. Makes the processes better through people. Connect to other departments and companies to benefit from best practices in different industries.

She/He will be accountable that everyone is properly trained in and adheres to internal procedures and standards.

He/she observes and stimulates opportunities for improvement and sets out a clear course to implement improvements in areas in need of improvement. He/she implements improvements both within their own department as company-wide and stimulates their employees to do the same.

Qualifications:

Required:

A minimum of a Bachelors degree At least bachelor certification e.g. (bio)science process engineering.

• Minimum of 8 years practical industrial experience.

• Minimum 5 years experience in a managerial position.

Technical/knowledge:

• Excellent command of Dutch and English in reading writing and speaking. Shown to have excellent EHS&S awareness

• Shown to have excellent cGMP awareness & experience

• Supply chain knowledge: Understands key principles and priorities central to effective supply chain management.

• Understands the market dynamics and the economies of scale supply and demand.

• Performance management: Measures the success of a strategy/activity/plan that was implemented against agreed upon standards/KPIs to determine its impact on organizational profitability.

• .Data gathering and analyses: Collects and synthesizes information to enable strategic decision making. Uses a variety of data analysis tools techniques and methodologies

The anticipated base pay range for this position is 82900.00 - 141100.00

In addition to base pay we offer the following benefits*: an annual bonus with set target 10% depending on pay grade / location where the actual amount is based on the employees and companies performance of the previous calendar year or sales commissions. Moreover we offer vacation days parental leave for a minimum of 12 weeks bereavement leave caregiver leave volunteer leave well-being reimbursement and programs for financial physical and mental health. We also offer service anniversary and recognition awards and subject to the terms of their respective plans employees - and in some locations eligible dependents - can participate in several insurance plans. For more information visit Employee benefits Supporting well-being & career growth Johnson & Johnson Careers.
*This is for informative purposes only. Amounts and actual benefits may vary by location and are subject to change.

Required Skills:

Preferred Skills: