Lc-ms-ms Bioanalysis Manager
Il y a 2 mois
**Description**
**Manager, Bioanalysis**
LC-MS-MS Bioanalysis manager, LC-MS-MS Bioanalytical study phase manager
Project Manager Role: Serve as the Principal Investigator for pre-clinical and clinical bioanalytical studies linked to LC-MS-MS platform (GLP, GCLP environment)
- Primary client liaison and point of contact for assigned sponsor projects. Receive and distribute information as appropriate from each of these sponsors. Keep the sponsors fully informed of timelines, project milestones and ensure timely communication on bioanalytical studies.
- Support business development activities to grow and maintain new and existing clients.
- Prepare, revise and/or approve all documentation related to the assigned projects..
- Manage the assigned resources of projects to ensure client timelines are met.
- Responsible for the technical and regulatory requirements of the bioanalytical study.
- Direct and participate in the development of new bioanalytical methods.
- Provide technical expertise to the laboratory staff.
- Daily interaction with the scientific team and management to establish priorities of assignments.
- Review audit reports and observations in order to maintain a high level of quality and consistency.
- Ensure monitoring of corrective actions and preventive actions (CAPA).
- Ensure the smooth functioning and quality of result analysis.
- Involve in problem solving and decision-making.
- Involve in bioanalytical report writing and prioritization.
- Ensure compliance and evaluate, identify and communicate the regulatory risks to senior management.
- Participate in the harmonization of work methods between the different divisions/services as well as the different sites.
- Participate in drafting/revising SOPs.
- Optimize and ensure the implementation of their teams working procedures and techniques in order to improve quality.
- Direct and guide archive management within the division.
Participate in regulatory agency inspections and client audits as well as the ensuing response process
Team manager role (GLP, GCLP environment):
- Plan, organize, manage and monitor their work unit’s activities according to their field of expertise, the work plan, and the needs of the organization in order to achieve the expected results.
- Manage human capital including workforce planning, hiring, performance management and daily monitoring of productivity; facilitate knowledge development and ensure the team’s efficiency and mobilization
Manage human capital including workforce planning, hiring, performance management and daily monitoring of productivity; facilitate knowledge development and ensure the team’s efficiency and mobilization.
- Help to develop their work unit’s performance indicator systems and the analysis of established objectives. Identify opportunities for improvement in order to amend the master plan and processes. Determine, as needed, the necessary actions to be taken in order to streamline efficiency.
- Contribute to the development of the sector’s budget and ensure that it is being adhered to, perform budget follow-up for pertinent stakeholders and recommend actions in an effort to achieve the expected results.
- Communicate the necessary information to keep their team(s) and the organization abreast of their team’s work plan, policies, projects, processes, results, actions and recommendations taken to meet arising needs.
- Ensure training is available for team members.
- Represent their work units, both internally and externally, as to consultation and/or information and/or reference.
- Advise internal/external clients of their division’s particular areas of expertise by assessing needs, and by carrying out analysis and follow-ups.
Syneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.
Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.
Discover what our 29,000 employees, across 110 countries already know:
**WORK HERE MATTERS EVERYWHERE**
**Why Syneos Health**
- We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
- We are committed to our Total Self culture - where you can authentically be yoursel
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