Lead Sterile Area, St.7 at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Senior (5 to 8 years), Expert & Leadership (9+ years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, Manufacturing, BiotechnologyIndustries

Requirements

Degree in CTF, Chemistry, Chemical Engineering, or a Diploma with relevant experience
Proficiency in the main software applications
New graduates are welcome, or a few years of experience in similar departments
Proficiency in English
Proven leadership and group management skills
High sense of responsibility and availability

Responsibilities

Successfully implement detailed production plans by assigning tasks to operators in accordance with budget and planning instructions
Coordinate world-class standards in production quantities, timing, and quality through effective direction, coordination, and control; lead all aspects of batch records and department documentation to guarantee compliance
Collaborate with the Department Supervisor to monitor SOP application, ensure compliance with master batch record instructions, and verify in-process controls; validate production data aligns with GMP and company policies
Continuously update SOPs and operational procedures, ensuring they meet current GMP requirements and align with Supervisor instructions
Manage the inventory levels of the department by ordering necessary consumables, ensuring compliance with the assigned budget
Assist the Supervisor in controlling costs by accounting for activities and loading products into the IT system, adhering to budgetary constraints
Coordinate maintenance activities with Technical Services, ensuring production plant efficiency and timely anomaly reporting; support problem-solving for production issues
Coordinate the execution of chemical and microbiological sampling activities and lead all aspects of the accurate compilation of related documentation
Lead, coordinate, and motivate the dependent structure; define objectives, improve results, and address training and development needs to ensure high performance

Skills

Key technologies and capabilities for this role

GMPProduction PlanningBatch RecordsSOPQuality ControlInventory ManagementCost ControlMaintenance CoordinationSamplingPersonnel ManagementTeam Leadership

Questions & Answers

Common questions about this position

What qualifications are required for the Lead Sterile Area position?

Candidates need a Degree in CTF, Chemistry, Chemical Engineering, or a Diploma with relevant experience, proficiency in main software applications, proficiency in English, and proven leadership and group management skills.

Is prior experience required for this role?

New graduates are welcome, or candidates with a few years of experience in similar departments.

What is the work schedule for this position?

The role involves a rotational shift including nights and weekends.

What salary or compensation does this position offer?

This information is not specified in the job description.

What makes a strong candidate for this lead role?

Strong candidates will have proven leadership and group management skills, a high sense of responsibility and availability, along with a relevant degree or diploma and proficiency in English.

Thermo Fisher Scientific

Provides life sciences products and services

About Thermo Fisher Scientific

Thermo Fisher Scientific offers a variety of products and services that support scientific research and healthcare, including laboratory equipment, reagents, and software solutions. Their products are used in applications like protein biology, real-time PCR, and sequencing, serving clients such as academic institutions and pharmaceutical companies. Unlike competitors, Thermo Fisher emphasizes customer support and education, helping clients optimize their experiments. The company's goal is to be a leading provider of life sciences solutions that contribute to a healthier and safer world.

Waltham, MassachusettsHeadquarters

1956Year Founded

$17MTotal Funding

IPOCompany Stage

Biotechnology, HealthcareIndustries

10,001+Employees

Risks

Increased competition in single-use bioprocessing may impact market share.

Sale of anatomical pathology business could create a temporary product gap.

Investment in miDiagnostics may face regulatory challenges affecting returns.

Differentiation

Thermo Fisher offers a comprehensive range of life sciences products and services.

Their well-known brands include Thermo Scientific, Applied Biosystems, and Invitrogen.

They provide strong customer support and educational resources to optimize client workflows.

Upsides

Expansion of biologics production facility enhances capacity for precision biologics monitoring.

Investment in miDiagnostics aligns with demand for rapid diagnostic solutions in BioPharma.

Collaboration with Mainz Biomed positions them in the growing cancer detection market.

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