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 Group Leader ( Method Validation & Sample Analysis) for our Large Molecule Group located in Plainsboro, NJ.
Job Summary: With no supervision, schedule LM programs with PI's and maintain timelines for all studies. When necessary, serve as study director/principal investigator to perform MD, MV/MQ and Sample analysis for Large Molecule (LM) Bioanalysis projects. Troubleshoots Wet Lab, tissue culture Lab, instrumentation associated with LM Bioanalysis ADA and Nab assays. Assist in training of LM analysts on wet lab, Cell culture, and instrumentation associated with LM systems. Participate as LM representative on first client interaction calls with BD team. Can communicate; write responses to QC/QA findings. Communicate with Clients on specific projects that they are responsible. Accountable for accurate data submission and on time delivery of assigned projects.
Essential Job Functions:
- Leads Large Molecule Immunogenicity teams (ADA & NAb) to conduct preclinical and/or clinical method development, validation and sample analysis. Plans, schedules, and coordinates studies with department head, staff, and sponsors.
- Acts as principal investigator and project manager to coordinate and conduct large molecule immunogenicity bioanalytical studies and duties. Develops, improves, and validates methods and/or SOPs according to the most up-to-date FDA Guidance, industry practice, and sponsor requirements.
- Guides PIs to manage studies through study plan, method, data processing, report, trouble shooting, investigations, and method performance trending. Trains scientists on laboratory skills and operation procedures.
- Functions as expert large molecule immunogenicity consultant to staff, management, and clients. Presents summaries of work to peers, management, and clients.
- Assumes ownership of department instruments. Assists and coordinates department instrument qualification and validation. Provides recommendations to management on procurement of equipment and materials. Maintains, calibrates, and troubleshoots instrumentation. Manages, archives, and maintains all data generated from operations.
- Strong understanding of Good Laboratory Practices and regulatory guidance on immunogenicity methods. Implement GLP and other pertinent regulatory requirements as called for by study protocols.
- Maintains large molecule research services facility at state-of-the-art level in accordance with company goals. Maintains and ensures laboratories safe workplace and regulated environment. Provides input to management concerning biological research and operation issues.
- Assists and collaborates with other LM BAS group leaders and management on daily operation and team development.
- Promotes company's safety policies, practices and procedures in order to maintain a safe work environment.
- Other duties as assigned.
Experience / Education:
- Ph.D or M.S. degrees in biology or related fields, or equivalent
- 5-8 years of hands-on industrial experience with Immunogenicity bioanalysis operations in a GLP facility, or equivalent. CRO experience is a plus.
- Any similar combination of education and equivalent work experience
Knowledge / Skills / Abilities:
- Expert working knowledge and leadership ability in large molecule immunogenicity bioanalysis field with ability to conduct challenging studies under limited supervision
- Knowledge and experience of commonly used scientific concepts, practices, and procedures within the pharmaceutical R&D industry. Ability to research and evaluate data and research results
- Thorough understanding of regulatory guidance and adherence to regulatory guidelines and SOP requirements on regulated bioanalysis
- Well organized, detail oriented, and adaptable to changes. Ability to work under pressure of multiple projects and deadlines. Ability to effectively prioritize workload and manage changes in direction
- Effective oral and written communication skills. Effective interpersonal skills
- Software expertise: MSD Discovery Workbench, SoftMax Pro GxP, Watson 7.4 IRM, etc.
- ELN experience a plus
- Must be able to work in an office environment with minimal noise conditions.
- Must be able to work in Lab setting
- Must be able to wear appropriate PPE
- Must be able to work in environment with variable noise levels
- Ability to stand/Sit/walk for long periods of time
- Ability to crouch, bend, twist, and reach
- Ability to push/pull 10 lbs occasionally
- Clarity of Vision
- Ability to identify and distinguish colors
- Must be able to perform activities with repetitive motions
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.