Site Lead- Malvern
Apply NowCompany: Resolian
Location: Malvern, PA 19355
Description:
Job Description
Responsibilities
Develop and maintain the plans for the site, including financial, personnel and capex and manage the budget and resources.
Represent the site to senior leadership and to clients.
Collaborate with senior leadership on the development and execution of operational and scientific strategic plans.
Manage a team of operational managers and scientific leads to deliver customer projects on time and in budget.
Ensure effective project and resource scheduling.
Maintain and improve upon the quality system and SOPs to ensure projects are conducted in compliance with GxP, act as GLP Test Facility Management.
Ensure adherence to all applicable regulatory requirements (GxP, CLIA, CAP and federal and state regulations).
Collaborate on harmonization and alignment efforts across the Resolian site network.
Develop and monitor appropriate Key Performance Indicators (KPIs) and use them to champion a culture of continuous improvement.
Monitor and address operational issues, troubleshoot problems, and implement corrective actions.
Ensure talent development strategies are in place to support future business growth.
Recruit and manage staff
Build Resolian's reputation for scientific leadership within the industry.
Develop strong relationships with key clients.
Other duties as assigned.
Skills, Education & Qualifications
BSc/ PhD in Biology, Chemistry or related area plus 15+ years bioanalytical experience
Experience in leading laboratory operations within a CRO or Pharma company with demonstrated experience in scaling an organization.
A background in regulated bioanalysis.
In-depth knowledge of GLP regulations as applied to bioanalytical laboratories.
Experience in GxP inspections by Health Authorities such as MHRA, EMA or FDA.
Expertise in the application of the latest bioanalytical method validation guidelines.
Knowledge of P&L management, budget setting and financial forecasting.
Demonstrated experience in successfully managing a P&L and driving efficiencies.
Proven ability to mentor and develop team to achieve high performance.
Demonstrated ability to manage the operations for large and diverse groups.
Exquisite communication and interpersonal skills
Ability to problem solve in challenging situations and confidently interact with clients during challenging times
Experience in the practical application of continuous improvement / lean principles.
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.
Responsibilities
Develop and maintain the plans for the site, including financial, personnel and capex and manage the budget and resources.
Represent the site to senior leadership and to clients.
Collaborate with senior leadership on the development and execution of operational and scientific strategic plans.
Manage a team of operational managers and scientific leads to deliver customer projects on time and in budget.
Ensure effective project and resource scheduling.
Maintain and improve upon the quality system and SOPs to ensure projects are conducted in compliance with GxP, act as GLP Test Facility Management.
Ensure adherence to all applicable regulatory requirements (GxP, CLIA, CAP and federal and state regulations).
Collaborate on harmonization and alignment efforts across the Resolian site network.
Develop and monitor appropriate Key Performance Indicators (KPIs) and use them to champion a culture of continuous improvement.
Monitor and address operational issues, troubleshoot problems, and implement corrective actions.
Ensure talent development strategies are in place to support future business growth.
Recruit and manage staff
Build Resolian's reputation for scientific leadership within the industry.
Develop strong relationships with key clients.
Other duties as assigned.
Skills, Education & Qualifications
BSc/ PhD in Biology, Chemistry or related area plus 15+ years bioanalytical experience
Experience in leading laboratory operations within a CRO or Pharma company with demonstrated experience in scaling an organization.
A background in regulated bioanalysis.
In-depth knowledge of GLP regulations as applied to bioanalytical laboratories.
Experience in GxP inspections by Health Authorities such as MHRA, EMA or FDA.
Expertise in the application of the latest bioanalytical method validation guidelines.
Knowledge of P&L management, budget setting and financial forecasting.
Demonstrated experience in successfully managing a P&L and driving efficiencies.
Proven ability to mentor and develop team to achieve high performance.
Demonstrated ability to manage the operations for large and diverse groups.
Exquisite communication and interpersonal skills
Ability to problem solve in challenging situations and confidently interact with clients during challenging times
Experience in the practical application of continuous improvement / lean principles.
About Us
Are you interested in working in science for a leading global Contract Research Organization that is expanding rapidly and delivering best in class service to its clients? If you are ambitious and hard working then keep reading, as we are looking for talented individuals like you.
We are globally recognised for our leadership in science and, as a result, you will have the opportunity to work with some of our industries smartest and most inquisitive people, in a flexible and supportive environment. It is the ideal place to expand your knowledge, take on new responsibilities and make ambitious strides in your career.
If you want to join us to help us deliver our mission of using our scientific capabilities to improve the quality of life of people, then we would love to hear from you.