Manager, R&D - CPD Empleos | Baxter (Ahmedabad)

Manager, R&D - CPD

Baxter

Ubicación:
India , Ahmedabad

Categoría:
Investigación y Desarrollo

Tipo de contrato:
No proporcionado

Salario:

No proporcionado

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Descripción del trabajo:

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

Responsabilidades:

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

Requisitos:

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
The ability to enthusiastically attack a problem and generate the results towards a clear and logical summary in a timely manner
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: M. Pharm / M.S. (Pharm.) / Ph.D.
Experience: 15 - 20 Years

Lo que ofrecemos:

Apoyo a las padres
Educación continua/ Desarrollo profesional
Salud de los empleados y Beneficios de bienestar
Tiempo libre pagado
2 días al año para ser voluntario

Información adicional:

Oferta publicada:
14 de febrero de 2026

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Manager, R&D - CPD

Baxter

Ubicación:
India , Ahmedabad

Categoría:
Investigación y Desarrollo

Tipo de contrato:
No proporcionado

Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:
14 de febrero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

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Manager, R&D - CPD

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Salario:

Descripción del trabajo:

Responsabilidades:

Requisitos:

Información adicional:

Oferta publicada:14 de febrero de 2026

¿Buscas más oportunidades? Busca otras ofertas de trabajo que coincidan con tus habilidades e intereses.

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