Senior Scientist QA Operations at Thermo Fisher Scientific

Lengnau, Bern, Switzerland

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Not SpecifiedCompensation

Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

PharmaceuticalIndustries

Requirements

Pharmacist or scientist with a master’s degree or equivalent experience
At least 3-5 years in the pharmaceutical industry, with not less than 1 year in commercial batch release
In-depth knowledge of pharmaceutical manufacturing processes, especially biologic drug substances
Proficient in German and English, with strong communication skills
Experience with SAP and electronic MES (Manufacturing Execution System) is an asset
Availability for on-call services and remote work as needed

Responsibilities

Ensure compliance of the manufacturing processes, batch records, deviations, change controls, and CAPA
Review and approve completed batch records within strictly defined timelines
Responsible for the technical batch release, ensuring products meet the highest standards
Provide active on-the-floor support during critical manufacturing steps
Evaluate and sanction operational documents, such as procedures, specifications, and working instructions
Assist with continuous improvement initiatives related to quality documents and processes
Supervise the preparation and execution of the Annual Product Quality Review (APQR)
Adhere to and promote data integrity rules (ALCOA+)
Make proposals to improve manufacturing flows, activities, and organization

Skills

Key technologies and capabilities for this role

CAPABatch RecordsDeviationsChange ControlsAPQRSAPMESALCOA+BiologicsPharmaceutical Manufacturing

Questions & Answers

Common questions about this position

What qualifications are required for the Senior Scientist QA Operations role?

Candidates need a master’s degree or equivalent experience as a pharmacist or scientist, at least 3-5 years in the pharmaceutical industry with 1 year in commercial batch release, in-depth knowledge of pharmaceutical manufacturing processes especially biologic drug substances, proficiency in German and English with strong communication skills.

Is remote work available for this position?

Remote work is available as needed, along with on-call services.

What is the salary or compensation for this role?

This information is not specified in the job description.

What is the team culture like at Thermo Fisher Scientific for this role?

You will be part of an ambitious team that strives for flawless execution and proven results.

What experience makes a strong candidate for this position?

Strong candidates have experience with SAP and electronic MES, which is considered an asset, in addition to the required pharmaceutical industry background and language skills.

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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