|Job Description :
||Manager, Bioanalysis – (22003022)
Come discover what our 25,000+ employees already know: work here matters everywhere. We’re a growing and evolving biopharmaceutical industry leader, which means you’ll have endless opportunities to work with experts around the world and build the career you’ve dreamed of.
As a part of the Syneos Health team, you’ll help us deliver results for a rewarding reason – we improve patients’ lives around the world. Because to us, a patient isn’t just a number, they’re our family, friends, and neighbors.
Why Syneos Health
#SyneosHealthLife means we’re committed to our Total Self culture – where everyone can authentically be themselves. Our Total Self culture is what unites us globally, and we know every person’s unique contributions make a difference.We believe our success is a direct result of the people who are driving it – you! We value your dedication to care for our customers and patients, so we want to focus on taking care of you. That’s why we offer a comprehensive benefits program encompassing your total health – physical, mental and financial.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.
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.
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.
As a healthcare company we have an important responsibility to protect individual and public health. This position will require individuals to be fully vaccinated against COVID-19 as part of their job responsibilities, unless an exemption can be confirmed based on a medical condition or sincerely held religious belief. Submission & Approval of an Exemption does not guarantee that an exemption can be accommodated.
Get to know Syneos Health
We are the only full-service biopharmaceutical solutions company in the world. That means we bring together the best clinical and commercial minds to create a better, smarter, faster way to get medicines into the hands of patients who need it most. Learn more about Syneos Health.
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.
Primary Location: North America – US Home-Based
Job: Research & Analysis
Travel: Yes, 25 % of the Time
Employee Status: Regular