PDS Master Batch Record Specialist at Thermo Fisher Scientific

Monza, Lombardy, Italy

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Not SpecifiedCompensation

Mid-level (3 to 4 years)Experience Level

Full TimeJob Type

UnknownVisa

Pharmaceuticals, BiotechnologyIndustries

Requirements

Degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering or equivalent
GMP, Pharma background, manufacturing of sterile products knowledge is preferred
Outlook Package Knowledge
Good knowledge of the English language (both written and spoken)

Responsibilities

Creation and revision of Master Batch Records in order to ensure cGMP compliance with EMA and US FDA requirements
Personnel training, checking of correct applications of GMP and operating procedures
Full cooperation in the different phases of the projects implementation and validation
Implementation of CAPAs and action from Change Control in the MBRs
Involvement in the technical meeting with the clients for the introduction of the new process/products in our PDS sterile departments and for the revision of MBR instructions directly with client through call or dedicated meeting
Support internal audits, client audit/Regulatory inspections
Management of the client’s requests about production processes
Collaboration with the whole QO, Process Scientist, MSAT, Equipment Validation, Supply chain, Production Dept
Involvement in training courses

Skills

Key technologies and capabilities for this role

GMPcGMPEMAFDAMaster Batch RecordsCAPAChange ControlSterile ManufacturingPharmaceutical ManufacturingAuditsPersonnel TrainingOutlookEnglish

Questions & Answers

Common questions about this position

What is the work schedule for this position?

The work schedule is standard Monday through Friday.

What degree is required for the PDS Master Batch Record Specialist role?

A degree in Chemistry, Chemical, Pharmaceutical Technology or Industrial Engineering Engineering or equivalent is required.

What key skills and knowledge are preferred for this position?

GMP and pharma background, knowledge of manufacturing sterile products, Outlook Package knowledge, and good knowledge of English (both written and spoken) are preferred.

What is the team environment like for the Master Batch Record team?

The team operates in a highly dynamic and goal-oriented environment, collaborating with QO, Process Scientist, MSAT, Equipment Validation, Supply chain, and Production Dept to craft manufacturing instructions for world-class clients.

What makes a strong candidate for this role?

Candidates with a relevant degree, GMP and pharma background especially in sterile products manufacturing, English proficiency, and experience in technical collaboration and compliance will stand out.

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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