Technical Operations Manager

Overview

The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets. The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets. The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets. The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.

The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.

The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.The Waters Advanced Diagnostics (ADx) Division provides globally recognized scientific and commercial leadership in clinical diagnostics, enabling laboratories to deliver high-quality, reliable results that improve patient care. Through workflow-based solutions, the ADx division advances the adoption of LC-MS as a routine diagnostic technology across global clinical markets.

The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsible for end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.

The Technical Operations Manager is a new role created within the ADx LC-MS R&D organisation responsibleThe Technical Operations Manageris a new role created within the ADx LC-MS R&D organisation responsibleforforend-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.end-to-end process verification and validation, scale-up, and transfer of manufacturing processes to support robust, compliant, and cost-effective production for products to be distributed in highly regulated markets.

Responsibilities

Lead and manage the Technical Operations team. Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)Implement a quality by design (QBD) approach and mindset into the team.Ensure processes are capable, reproducible, and scalable.Manage transfer of products from R&D to manufacturing.Lead and manage the Technical Operations team. Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)Implement a quality by design (QBD) approach and mindset into the team.Ensure processes are capable, reproducible, and scalable.Manage transfer of products from R&D to manufacturing.Lead and manage the Technical Operations team. Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)Implement a quality by design (QBD) approach and mindset into the team.Ensure processes are capable, reproducible, and scalable.Manage transfer of products from R&D to manufacturing.

• Lead and manage the Technical Operations team.

Lead and manage the Technical Operations team.Lead and manage the Technical Operations team.

• Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ) aligned with regulatory expectations (FDA QSR, IVDR)

Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ)Responsible for design and execution of process verification and validation activities (IQ/OQ/PQ, PV, PPQ)aligned with regulatory expectations (FDA QSR, IVDR)aligned with regulatory expectations (FDA QSR, IVDR)

• Implement a quality by design (QBD) approach and mindset into the team.

Implement aImplement aquality by design (QBD)quality by design (QBD)approachapproachand mindsetand mindsetinto the team.into the team.

• Ensure processes are capable, reproducible, and scalable.

Ensure processes are capable, reproducible, and scalable.Ensure processes are capable, reproducible, and scalable.Ensure processes are capable, reproducible, and scalable.

• Manage transfer of products from R&D to manufacturing.

Manage transfer of products from R&D to manufacturingManage transfer of products from R&D to manufacturing..

Qualifications

Education: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Experience: 8+ years experience in manufacturing, process development, or technical operationsCompetencies: Strong experience in: Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech). Statistical analysis and process capability tools.Proven track record of delivering robust, scalable manufacturing processes. Travel (If Applicable): MinimalEducation: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Experience: 8+ years experience in manufacturing, process development, or technical operationsCompetencies: Strong experience in: Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech). Statistical analysis and process capability tools.Proven track record of delivering robust, scalable manufacturing processes. Travel (If Applicable): MinimalEducation: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Experience: 8+ years experience in manufacturing, process development, or technical operationsCompetencies: Strong experience in: Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech). Statistical analysis and process capability tools.Proven track record of delivering robust, scalable manufacturing processes. Travel (If Applicable): Minimal

Education: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.

Education: Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Education:Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Bachelor’s or Master’s degree in Engineering, Biotechnology, Life Sciences, or related field.Bachelor’s orMaster’s degree in Engineering, Biotechnology, Life Sciences, or related field.

Experience: 8+ years experience in manufacturing, process development, or technical operations

Experience: 8+ years experience in manufacturing, process development, or technical operationsExperience:8+years experiencein manufacturing, process development, or technical operations

Competencies:

Competencies:Competencies:

Strong experience in:

Strong experience in:Strong experience in:Strong experience in:

• Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech).

Process validation (IQ/OQ/PQ, PPQ) & Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech).Process validation (IQ/OQ/PQ, PPQ)&Scale-up and technology transfer in regulated environments (IVD, medical devices, pharma, biotech).egulated environments (IVD, medical devices, pharma, biotech).egulated environments (IVD, medical devices, pharma, biotech).

• Statistical analysis and process capability tools.

Statistical analysis and process capability tools.Statistical analysis and process capability tools.Statistical analysis and process capability tools.Statistical analysis and process capability tools.Statistical analysis and process capability tools.Statistical analysis and process capability tools.

• Proven track record of delivering robust, scalable manufacturing processes.

Proven track record of delivering robust, scalable manufacturing processes.Proven track record of delivering robust, scalable manufacturing processes.Proven track record of delivering robust, scalable manufacturing processes.Proven track record of delivering robust, scalable manufacturing processes.Proven track record of delivering robust, scalable manufacturing processes.Proven track record of delivering robust, scalable manufacturing processes.Proventrack recordof delivering robust, scalable manufacturing processes.

Travel (If Applicable): Minimal

Travel (If Applicable): MinimalTravel (If Applicable):