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Manager, R&D - CPD

https://www.baxter.com/ Logo

Baxter

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Location:
India , Ahmedabad

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Contract Type:
Not provided

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Salary:

Not provided

Job Description:

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.

Job Responsibility:

  • Planning and monitoring of analytical method development, validation, technology transfers, routine stability studies, PDR studies for regulatory submissions and subsequent query responses
  • 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 observed during the execution of analytical activity
  • To keep track of the activities assigned to the team and ensure timely completion
  • To ensure the availability of necessary resources
  • To review the weekly and monthly plan to ensure smooth implementation
  • 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
  • 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
  • Collaborate with cross functional team members
  • 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
  • Responsible for timely closure of LIR, NCR, CCN, CAPA
  • To ensure the compliance to Pharmacopoeia update for the assigned projects
  • Adherence to the Baxter's Code of conduct principles, SOP compliance
  • 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
  • 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

Requirements:

  • In-depth understanding of analytical method development, validation, technology transfers, pharmacopeial compliance, cGLP and good documentation practices (ALCOA++)
  • Proven expertise in leading complex projects involving proteins and peptides under GMP environment for regulatory submissions (e.g. US FDA approval on complex products)
  • Subject matter expertise in areas associated with modern analytical instrumentation such as HPLC, UPLC, GC, UV, MS, etc
  • Good understanding of current regulatory requirements for dossier submission
  • Proficiency in writing and computer skills
  • Good understanding of the latest quality and regulatory requirements and its implementation
  • Demonstrates critical thinking skills in problem solving and decision making
  • Good interpersonal & managerial skills
  • Ability to adapt to changes and to work in a team environment as well as delegate effectively
  • To perform review and approval related activity using business software like TCU, Electronic Notebooks, Trackwise, Coupa etc
  • M. Pharm / M.S. (Pharm.) / Ph.D.
  • 15 - 20 Years experience
What we offer:
  • Support for Parents
  • Continuing Education/ Professional Development
  • Employee Heath & Well-Being Benefits
  • Paid Time Off
  • 2 Days a Year to Volunteer

Additional Information:

Job Posted:
February 03, 2026

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