What are the responsibilities and job description for the Mgr, Bioanalysis position at Syneos Health - USA?
Description
Manager, Bioanalysis
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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 yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
Job responsibilities
• 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.
• 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.
• Participate in regulatory agency inspections and client audits as well as the ensuing response process.
Project manager role:
• 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.
• Serve as the Principal Investigator for pre-clinical and bioanalytical studies.
• Prepare, revise and/or approve all documentation related to the assigned projects.
• Prepare various quotes related to the service requests made by clients.
• 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.
• Administrative responsibilities including a detailed monthly forecast of revenue and a less detailed long-term forecast.
• Daily interaction with the scientific team and management to establish priorities of assignments.
Result analysis/reporting manager role:
• 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.
Qualifications
What we’re looking for
• Experience in the management of technical and scientific staff.
• Demonstrated leadership, line management, tactical and strategic thinking skills.
• Extensive knowledge of GLP/EMA guidelines and other applicable regulatory requirement.
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel.
• Excellent communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Experience within a client-service environment, either in a contract laboratory or within a core group at a pharmaceutical company.
• Demonstrate scientific problem solving skills.
• Ability to travel as necessary (approximately 5%)
• In-depth understanding and knowledge of the pharmaceutical industry and contract research organizations in general and the bioanalysis community specifically.
• English level (Quebec specific): Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000 Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
Manager, Bioanalysis
Syneos Health is the only fully integrated biopharmaceutical solutions organization purpose-built to accelerate customer success. We lead with a product development mindset, seamlessly connecting our capabilities to add high-value insights to speed therapies to patients and provide practical value to help our customers achieve their objectives.
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 yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
• We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we’re able to create a place where everyone feels like they belong.
Job responsibilities
• 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.
• 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.
• Participate in regulatory agency inspections and client audits as well as the ensuing response process.
Project manager role:
• 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.
• Serve as the Principal Investigator for pre-clinical and bioanalytical studies.
• Prepare, revise and/or approve all documentation related to the assigned projects.
• Prepare various quotes related to the service requests made by clients.
• 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.
• Administrative responsibilities including a detailed monthly forecast of revenue and a less detailed long-term forecast.
• Daily interaction with the scientific team and management to establish priorities of assignments.
Result analysis/reporting manager role:
• 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.
Qualifications
What we’re looking for
• Experience in the management of technical and scientific staff.
• Demonstrated leadership, line management, tactical and strategic thinking skills.
• Extensive knowledge of GLP/EMA guidelines and other applicable regulatory requirement.
• Must demonstrate good computer skills especially in the utilization of Microsoft Word and Excel.
• Excellent communications, presentation, interpersonal skills, both written and spoken, with an ability to inform, influence, convince, and persuade.
• Experience within a client-service environment, either in a contract laboratory or within a core group at a pharmaceutical company.
• Demonstrate scientific problem solving skills.
• Ability to travel as necessary (approximately 5%)
• In-depth understanding and knowledge of the pharmaceutical industry and contract research organizations in general and the bioanalysis community specifically.
• English level (Quebec specific): Required bilingualism includes communicating verbally and in writing on topics that are often technical, and writing procedures or technical reports.
Get to know Syneos Health
Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 Studies across 73,000 Sites and 675,000 Trial patients.
No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health
Additional Information:
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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