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| Head of Process Improvements |
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Develop risk assessment database of biotech drug substance (BDS) processes (as per ICHQ9) for marketed products in collaboration with Operational Excellence (OE), corporate Quality Management (cQM) and sites and develop improvement plans to minimize process/quality risks.
Develop strategy and tools for business/process improvements complying with current and future regulatory guidelines (PAT initiative, ICHQ10…).
Coordinate best practice sharing, educate and ensure implementation of business/process improvement strategy.
Coordinate, harmonize and ensure implementation of improvement programs that cover OE and local process improvements driven by OTS for key marketed biological molecules.
Support sites in analysis of BDS process performance by using most advanced statistical tools and information management system as well as in case of major process/quality failures.
Ensure harmonization of BDS processes and practices between manufacturing sites.
Tasks and Responsibilities
To assess biotech process risks and performance and identify areas that could affect business and process performance and/or drug substance quality.
To build BDS process knowledge in order to be able to make scientific and rational decisions for process improvement.
To propose Process Improvement Program to management based on the risks and performance analysis.
To manage the implementation of Process Improvement Plans.
To identify and implement methodology and tools for Process Improvement Programs.
To ensure that Process Improvement Programs applied to biotech drug substance are in compliance with current and future regulatory guidelines.
To provide support to improve process capacity, speed and cost as well as biotech drug substance quality, through Lean & Six Sigma methodology.
To manage and analyse data in order to ensure alignments between Drug Substance process of marketed products within sites in case of dual sources production, after process changes related to process improvement or during internal or external TT.
To centrally support investigations teams through root cause analysis methodologies and statistical tools.
To develop and promote sharing of biotech manufacturing knowledge through practice sharing forum and harmonisation meetings between sites & biotech process development.
To coordinate and align process improvement initiatives such as the ones initiated from BDS sites, operational excellence initiatives or others.
Performance Measurements
Implementation of process improvement programs in all biotech manufacturing sites.
Overall savings and/or improvements induced by implementation of process improvement programs in Biotech Manufacturing sites.
Reliability of BDS process performance.
Education of production managers and OTS managers in biotech manufacturing sites on tools for process knowledge and troubleshooting.
Organization of forums for best practice sharing with Biotech Manufacturing sites.
Overall recognition by peers as a leader in business improvement. |
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Engineering Degree (Chemistry, Biology, Pharmacy)
Doctorate (Chemistry, Biology, Biochemistry, or Biotechnology)
Other certification (Black Belt Certification)
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10 years + |
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English : Speak / Write Fluently
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open-ended |
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unspecified |
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EU National |
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Vaud Vevey |
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Degree in Engineer, Chemistry, Biology, Pharmacy or equivalent.
PhD in Chemistry, Biology, Biochemistry, Biotechnology or equivalent.
Black Belt Certification is a plus.
Fluent in English.
Several years of experience in Pharmaceutical or Biotech production and/ or process development managerial positions.
Sound awareness of biotech or pharmaceutical business.
Strong experienced in process improvement, problem solving and troubleshooting.
Ability to understand business constraints, analyse complex information, develop and propose solutions compatible with business requirements and constraints.
Strong interpersonal skills and ability to interact constructively with all functions in a matrix based organization.
Experienced team leader as well as committed team member.
Strong active listening skills and ability to articulate and formulate in a simple business language.
Strong results orientation.
Ability to represent the company internally and externally.
Good verbal and written communication skills. |
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Merck Serono is the division for innovative small molecules and biopharmaceuticals of Merck KGaA.
Merck Serono’s global headquarters are located in Geneva, Switzerland. |
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