Research Scientist I

Job Description

Research Scientist IApply Now Save JobThis is where you save and sustain livesAt Baxter, we are deeply connected by our mission. No matter your role at Baxter, your work makes a positive impact on people around the world. Youll feel a sense of purpose throughout the organization, as we know our work improves outcomes for millions of patients.Baxters products and therapies are found in almost every hospital worldwide, in clinics and in the home. For over 85 years, we have pioneered significant medical innovations that transform healthcare.Together, we create a place where we are happy, successful and inspire each other. This is where you can do your best work.Join us at the intersection of saving and sustaining lives where your purpose accelerates our mission.Job Title:Research Scientist IIJob Code:hidden_mobileFunction:Research Med DeliveryDate:February 2017FLSA:ExemptBroad Pay Group:DSummary:This section focuses on the main purpose of the job in one to four sentences.Extractables and Leachables Subject Matter Experts (SMEs) within the New Product Development (NPD) organization take ownership of the E&L strategy for a diverse product portfolio within the Pharmaceuticals Global Business Unit (GBU), interacting with numerous global cross-functional internal partners (Regulatory Affairs, Pre-Clinical Toxicologists, Device Engineers, Formulation Scientists & Quality) as projects progress from concept to launch and on-market support.We now have a vacancy for an analytical scientist with proven expertise in chromatographic and mass spectroscopic techniques, applied within a highly regulated environment. The successful candidate will be recognized for their strong analytical expertise and awareness of E&L, taking on the role of a regional point of contact for the Pharma E&L team. In this role, the successful candidate will have responsibility for the oversight of all project related activity, managing key stakeholders and customers and collaborating with a multidisciplinary team of subject matter experts to develop, execute and summarize the E&L strategy within global regulatory dossiers. The data generated plays a pivotal role in demonstrating the safety of the materials used to manufacture, package and deliver drug products within the Pharma portfolio. The scientist in this role will maintain a focus on innovation, process improvement, and operational initiatives.Essential Duties and Responsibilities:This section contains a list of primary responsibilities of this role that account for 5% or more of the work. The incumbent will perform other duties assigned.
• Regional (India) point of contact for the Extractable & Leachable team
• Oversight and management of a diverse range of projects of high complexity
• Applies practical and theoretical expertise in chromatographic (GC and LC), spectroscopic and mass spectrometry techniques to develop and execute non-routine experimental protocols
• Interfaces with internal partners to interpret complex analytical data; including quantitation, structural elucidation and toxicological assessment
• Authors and reviews a variety of technical reports, protocols, and regulatory dossiers
• Leads internal initiatives that enhance the operational excellence of the Pharma Extractable and Leachable team
• Develop new or improved techniques and procedures.
• Sought out by other teams and individuals to offer technical advice
• Innovates and implements novel technical approaches to trace analysis
• Present results at internal/external forums
Qualifications:To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. List knowledge, skills, and/or abilities required. Reasonable accommodations may be made to enable individuals with disabilities to perform essential functions.
• Experienced (10+ years) analytical chemistry with strong technical background in chromatographic (GC & LC) techniques coupled to a Mass Spectrometer.
• Good understanding of Extractables/Leachables & the regulatory expectations for parenteral drug products
• Can comfortably handle ambiguity, risk and uncertainty; can decide and act without having the total picture.
• Must be able to contribute in setting strategic scientific direction for the organization and communicate the vision to his/her team members.
• Must be able to challenge the status quo.
• Ability to design experiments and draw meaningful conclusions from lab data.
Education and/or Experience:Include the education and experience that is necessary to perform the job satisfactorily.
• Bachelors degree in a scientific discipline with at least 10 years of relevant experience, MS with at least 7 years, or PhD with at least 5 years of relevant experience.
Reasonable AccommodationsBaxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to hidden_email and let us know the nature of your request along with your contact information.Recruitment Fraud Notice Baxter has discovered incidents of employment scams, where fraudulent parties pose as Baxter employees, recruiters, or other agents, and engage with online job seekers in an attempt to steal personal and/or financial information. To learn how you can protect yourself, review our Recruitment Fraud Notice .073958Apply Now Save Job,

Keyskills :
concept to launchhplcvalidationchemistryapi