WuXi AppTec is a leading global pharmaceutical, biopharmaceutical, and medical device open-access capability and technology platform with global operations. As an innovation-driven and customer-focused platform, WuXi AppTec Group provides a broad and integrated portfolio of services to help our worldwide customers and partners shorten the discovery and development time and lower the
cost of drug and medical device R&D through cost-effective and efficient solutions.
At our Laboratory Testing Division, we provide a world class, globally integrated testing solution for drug development and medical device innovation. We enable scientists to transform ideas into the best healthcare products, accelerate the race from bench to bedside, and ultimately improve human life.
Our New Jersey site specializes in small molecule bioanalytical, drug metabolism, and pharmacokinetic services to the pharmaceutical, animal health and agrochemical industries. We are seeking a Senior Project Manager within our Bioanalytical Group located in Plainsboro, NJ.
Job Summary: The Senior Project Manager is responsible for managing to deliver regulated bioanalytical services to sponsors. He / She is responsible for the scientific excellence, project management as well as client relationship development and maintenance in the bioanalytical field.
Essential Job Functions:
- Serve as a key contact for central communication source with sponsors, study directors, and subcontractors. Proactively manage on-going studies (long term and short term), close out past studies and plan for the future studies, work closely with internal teams to deliver the study milestones, identify and escalate the priorities.
- Interact with customers to provide technical guidance in response to client’s inquiries, current service concerns, and requests for more services
- Being subject matter of expert to support bioanalytical marketing and sales to bring in new clients and interacts with clients to expand WuXi AppTec’s bioanalytical reputation in the pharmaceutical industry.
- Work with internal bioanalytical team to enhance the bioanalytical operation on the design, planning, and operations of projects related to bioanalysis. May supervise bioanalytical scientists on a study or project related basis.
- Promotes compliance with GLP, FDA, EPA, and OECD, or other applicable regulations.
- Performs and/or oversees work to attain objectives.
- Reviews, compiles, records, calculates, and analyzes data in accordance with accepted standards and practices. Interprets significance of results and draws conclusions.
- Contributes to comprehensive reports, recommending application of findings and presents clear and concise oral reports of progress and accomplishments.
- May lead scientific projects as needed, including review of or development of protocols and modifications, and assisting staff with studies and reports.
- Evaluates performance of supervised staff and other personnel involved in bioanalytical research and development, quality control, and reporting.
- Guides and counsel’s employees to contribute to the goals of the company and to encourage personal growth.
- Promotes company’s safety policies, practices and procedures in order to maintain a safe work environment.
- Other duties as assigned.
Experience / Education:
- D. in chemistry, biochemistry, natural product chemistry, medicinal chemistry, or related field, or work equivalent experience.
- >10 years of relevant experience in Analytical Chemistry, Bioanalysis, Drug Development, knowledge of regulatory affairs in the pharmaceutical industry, or equivalent background
- Experience partnering with leaders in the pharmaceutical/R&D or technology environments; well-developed management skills
- Any similar combination of education and experience
Knowledge / Skills / Abilities:
- Expert knowledge of bioanalytical (LCMS, immunochemistry, etc)
- Knowledge of commonly used business concepts, practices, and procedures within the pharmaceutical R&D field
- A thorough understanding of the services provided by WuXi AppTec
- Ability to research and evaluate company-applicable types of data and research results
- Well organized, detail oriented, and adaptable to changes
- Effective oral and written communication skills
- Excellent interpersonal skills
- Familiarity with radiotracer, chromatographic and spectroscopic techniques, in addition to appropriate regulatory guidelines
- Computer skills: knowledge of internet research, MS Word, Excel, Outlook, and PowerPoint
- Ability to work under pressure of multiple projects and deadlines
- Ability to effectively prioritize workload and manage changes in direction
- Ability to work in a team environment
- Familiarity with and adherence to regulatory guidelines consistent with company requirements
- Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting with exposure to biohazards / Chemicals.
- Must not have animal allergies to applicable species in this facility
- Must be able to wear appropriate PPE
- Must be able to work in environment with variable noise levels
- Clarity of Vision
- Must be able to perform activities with repetitive motions
- Ability to climb Ladders / Stairs / Scaffolding
- Ability to work in variable temperatures high to freezing
An Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, or protected veteran status and will not be discriminated against on the basis of disability
This job description does not state or imply that the above are the only duties and responsibilities assigned to this position. Employees holding this position will be required to perform any other job-related duties as requested by Management.
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