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This manager position will act as sub-department leader of Complex Product Development group, managing GMP and non-GMP functions of the analytical department including analytical method development & validation, technology transfers, stability studies, regulatory query response and Plant/CMO support activities. This position will also look for other operational excellence of laboratory to ensure smooth operation of the laboratory function
Essential Duties and Responsibilities:
· Planning and monitoring of analytical method development, validation, technology transfers, routine stability studies, PDR studies for regulatory submissions and subsequent query responses as per schedule and work allocation to analyst.
· Manage Complex Product Development initiatives, including & not limited to, proteins and peptides, iron formulations, and other niche biopharmaceuticals
· To ensure in-depth understanding of the project and to provide all the documents as per committed timelines.
· To provide the technical support/guidance to the CMO/plant during OOS/OOT investigations.
· To guide the team in resolving the technical challenge (if any) observed during the execution of analytical activity and to keep the department head informed in case of any deviation from the committed timeline
· To keep track of the activities assigned to the team and ensure timely completion as per stipulated timelines
· To ensure the availability of necessary resources like impurities & standards, analytical columns or instruments to carry out the method development, validation, technology transfers, stability analysis and other relevant activities.
· To review the weekly and monthly plan to ensure smooth implementation of the plan in coordination with cross functions. To suggest planning department in advance, if any change is required.
· To resolve any analytical issue observed during routine analysis, method development, pre-validation studies, validation, technology transfer, etc.
· Implement new or improved techniques and procedures around specific tasks; write and implement SOP's.
· To provide response to the queries received from various regulatory agencies in scientific /logical manner within the stipulated timeline.
· Review of GLP activities and the related documents.
· Review and approval of standard operating procedures, methods of analysis, protocols & regulatory submission documentation.
· To check the pre-requirement for installation of instruments, review URS/RFPs and to ensure installation and qualification of Laboratory instruments in timely manner as per requirement.
· Collaborate with cross functional team members i.e., project management, quality team, regulatory affairs, formulation development, manufacturing site, other internal / external testing facilities and quality control lab for smooth execution of projects from analytical perspective.
· To review the status of daily work of the team and report to the manager.
· To review and to implement safety requirements as per organization’s policy.
· To plan capex for the department and ensure that it is spent in a timely manner.
· To ensure compliance/mitigation of HAZID, E&C, Data integrity, training & cGLP followed in the team
· Responsible for timely closure of LIR, NCR, CCN, CAPA and to ensure the implementation of appropriate Corrective and Preventive action wherever required.
· To ensure the compliance to Pharmacopoeia update for the assigned projects in timely manner
· Adherence to the Baxter's Code of conduct principles, SOP compliance pertaining to analytical, quality and R&D site
· API and excipient vendor approval process of new and existing products.
· Ensuring timely review of DMF of API vendors.
· To plan and allocate work or project to team members to ensure the timely delivery of projects.
· Approval of R&D specification, MoA for API, FP, excipients, and packaging material.
· To ensure the development of team members.
· Responsible for providing budget and its utilization in a timely manner to meet the purchase requirements of the project
Qualification:
· In-depth understanding of analytical method development, validation, technology transfers, pharmacopeial compliance, cGLP and good documentation practices (ALCOA++) is mandatory.
· Proven expertise in leading complex projects involving proteins and peptides under GMP environment for regulatory submissions (e.g. US FDA approval on complex products) is an essential requirement.
· Subject matter expertise in areas associated with modern analytical instrumentation such as HPLC, UPLC, GC, UV, MS, etc is required. Ability to learn and master new analytical techniques and develop new methods where appropriate. Understand why a technique is required not just how to do the technique. Sound understanding of the analytical instruments and good learning agility
· Good understanding of current regulatory requirements for dossier submission. Proficiency in writing and computer skills are relevant to recording original data as well as creating protocols, reports, and presentations to communicate with partners and team members.
· The ability to enthusiastically attack a problem and generate the results towards a clear and logical summary in a timely manner is required.
· Communication skills to build relationships across functional and geographical boundaries and present technical concepts to Cross Functional teams.
· Good understanding of the latest quality and regulatory requirements and its implementation.
· Demonstrates critical thinking skills in problem solving and decision making.
· Effectively presents information and ideas formally and informally, verbally and in writing to others in a manner that facilitates understanding
· Good interpersonal & managerial skills, can work collaboratively in an effective manner to achieve set objectives
· Ability to adapt to changes and to work in a team environment as well as delegate effectively to the team members.
· To perform review and approval related activity using business software like TCU, Electronic Notebooks, Trackwise, Coupa etc.
Education and/or Experience:
o Education:
· M. Pharm / M.S. (Pharm.) / Ph.D.
o Experience:
· 15 - 20 Years
Equal Employment Opportunity
Baxter 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, protected veteran status, disability/handicap status or any other legally protected characteristic.
Reasonable Accommodations
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities globally. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please click on the link here and let us know the nature of your request along with your contact information.
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