USP Shift Lead Manufacturing at Thermo Fisher Scientific

Lengnau, Bern, Switzerland

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Not SpecifiedCompensation

Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level

Full TimeJob Type

UnknownVisa

Biopharmaceuticals, Life Sciences, ManufacturingIndustries

Requirements

Bachelor/Master in Chemistry / Biochemistry / Biology / Food Science
5-7 years successful experience in pharmaceuticals operations in a GMP relevant environment
Experience in biotech or pharma processes, either in sterile processes, USP, DSP, solution preparation, single use, CIP/SIP processes
Good knowledge and competence in the field of automated processes
Experience in leading teams
Language: English or German
Shift work is expected
On-call support

Responsibilities

Responsible for the daily operations of their shift in manufacturing suites, including daily schedule, shift rotations
Lead and develop team members in order to run areas robustly and smoothly, ensuring appropriate succession planning
Participates in defining robust process parameters during routine manufacturing campaigns
Build cross functional teams and work well with other support functions such as Quality Assurance, Quality Control, Manufacturing Science and Technology, Engineering, Validation, and other relevant functional areas
Ensures implementation of and adherence to current GMP rules, Quality policies, procedures and instructions for their area of responsibility
Ensures contribution of their interpersonal unit to continuous quality improvement initiatives and deviation reporting and follow-up
Ensures implementation of and adherence to EHSS legal requirements, rules, policies, procedures and instructions for their area of responsibility
Ensures contribution of their interpersonal unit to EHSS initiatives and issues as well as near miss reporting and follow-up
Leads a manufacturing team (shift in upstream, downstream, solution preparation and support) to ensure the operational activities for the production of recombinant products
Supports project teams in the design, commissioning, qualification and validation of new production lines for recombinant products
Supports New Product Introduction for recombinant products

Skills

Key technologies and capabilities for this role

GMPCleanroomPPEUpstream ProcessingDownstream ProcessingSolution PreparationBiomanufacturingQualificationValidationCommissioning

Questions & Answers

Common questions about this position

What are the main responsibilities of the USP Shift Lead Manufacturing role?

The role involves leading a manufacturing team on shift for upstream, downstream, solution preparation and support, ensuring daily operations and schedules, developing team members, supporting new production lines and product introductions, and ensuring GMP and EHSS compliance.

What is the work schedule for this position?

The work schedule is rotational days and weekends.

What environmental conditions will I work in?

The role requires adherence to GMP safety standards in cleanrooms (no hair products, jewelry, etc.), cold rooms/freezers at -22°F/-6°C, office settings, and use of PPE like safety glasses, gowning, gloves, lab coat, and ear plugs.

What leadership and teamwork skills are needed for this role?

Candidates need strong leadership to lead and develop manufacturing teams, build cross-functional teams with QA, QC, Engineering, and others, and ensure smooth operations with succession planning.

Is this a remote position, or is it on-site?

This is an on-site role at the manufacturing facility in Lengnau, involving shift work in manufacturing suites, cleanrooms, and cold rooms with required PPE.

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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