Manager - Chromatography and Stability

Job Description

Manager - Chromatography and StabilityApply 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.About BaxterBaxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter s employees worldwide are building upon the company s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.Job Summary Job Title Mgr- Chromatography & Stability Location Whitefield, Bangalore Shift General The successful candidate will manage a diverse team of scientists that specialize in analytical chemistry and stability as applied to drug products and medical devices product. This role is based in R&D of Renal Global Business Unit (GBU) of Baxter and thus majority of the projects will be associated with this GBU s product line. In addition to Renal Care, the Acute Therapies GBU will be supported. The team will develop, validate, transfer, assess analytical methods, work with broad array of state-of-the art analytical methods/ techniques with special emphasis on chromatography. In addition to analytical support to new product development and sustaining projects, the team members will also play key roles in design, implementation, and documentation of stability protocols for Baxter s product lines. The manager of the group will be accountable for project execution, quality & accuracy of all the analyses done in the team and appropriate resource allocation keeping in mind business priorities. The successful candidate will be responsible for developing strategic technology direction for the team and grow talent by actively engaging with team members for their continuous professional growth. Job Responsibilities:

• Lead Chromatography and Stability team in India within Renal Solutions R&D. The team will provide technical expertise primarily to Renal and Acute GBUs of Baxter.
• Work closely with global Analytical Chemistry &Stability team members within Renal Solutions R&D to define scope of work on projects as well as contribute to the definition & execution of global strategy for talent development, capability & capacity for AC&S organization.
• Select, develop and retain team. Define and communicate criteria by which team and individual success will be measured. Provide constructive feedback and recognition. Effectively coach, mentor and motivate others for outstanding performance.
• Solve problems expeditiously using multiple disciplines and technical principles.
• Work collaboratively and effectively with other global analytical chemistry, stability, materials science, extractables and leachables, spectroscopy, and microscopy/particle analysis leads.
• Work collaboratively and effectively with project management office, sustaining product and new product development leads, Regulatory Affairs, Quality Assurance, and other business partners as and when needed.
• Provide leadership to team members, guiding them in terms of prioritization, problem resolution, process clarification, referrals to appropriate experts, etc.
• Develop effective project schedules and manage project budgets for internal and external activities, as required. Employ project management tools to manage to those project schedules.
• Review and apply best-demonstrated practices, team processes, and improve operational efficiency. Seek regular input and feedback from requestors and take appropriate action. Identify and initiate discussion of key business issues affecting the project.
• Proactively prioritize and balance utilization of resources allocated to project; identify opportunities to cross-train, back-fill. Develop recommendations for outside resources as required for the team/project, present internal vs. external analysis.
• Attend project review and core team meetings, as necessary.
• Build a professional network both internally within the Renal R&D organization, across various business units and outside of Baxter.
• Maintain knowledge of relevant Quality System Regulations and safety requirements while building knowledge of other regulatory requirements related to Renal R&D (product development, design, safety) to ensure compliance in all research, data collection and reporting activities.

Qualifications & Skills

• Demonstrated expertise in Chemistry, in particular analytical methods for pharmaceutical industry.
• Demonstrated experience and ability to deeply engage and critically review technical aspects of analytical method assessments, validations, and transfers, stability planning, and investigations.
• Demonstrated ability to lead teams of SMEs / technical experts in above-mentioned technical disciplines
• Capable of independently analyzing and solving complex problems through innovative thought and experience, as well as project management tools.
• Ability to oversee and implement projects/studies outside their area of expertise.
• Communicate effectively using a wide variety of skills and vehicles and to various audiences including senior management.
• Must demonstrate strategic leadership and proficient supervisory skills.
• Ability to lead, guide and coach scientists working in cross-functional project teams.
• Contribute to efforts beyond own scope of responsibilities to ensure project milestones are met.
• Willingness to work across multiple time zones.
• Possess strong time management skills. Must demonstrate flexibility and the ability to shift gears between projects and multi-task comfortably.
• Functional understanding of cGxPs, FDA guidelines and Quality systems.
• Must have knowledge of ISO and ICH guidance as related to the quality components associated with pharmaceutical development.

Education/ Experience :

• Master s Degree in Chemistry, Pharmaceutical sciences, or related disciplines with minimum 12 years of relevant experience (or Ph.D. with minimum 10 years experience) in pharma or medical devices industry.
• Highly desirable: at least 2 years experience should be in a people leader role (a role having direct reports) for analytical chemistry related team in Pharmaceutical companies.

Equal Employment OpportunityBaxter is an equal opportunity employer. Baxter evaluates qualified applicants without regard to race, color, religion, gender, national origin, age, sexual orientation, gender identity or expression, disability/handicap status or any other legally protected characteristic.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 Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.041213Apply Now Save Job,

Keyskills :
Chromatographybusiness unitsquality systemmedical devicesdata collectiontime managementglobal strategy