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Mgr, R&D - Adl

0-2 years
Not Disclosed
10 Oct. 30, 2025
Job Description
Job Type: Full Time Education: B.Sc/M.Sc/M.Pharma/B.Pharma/Life Sciences Skills: Causality Assessment, Clinical SAS Programming, Communication Skills, CPC Certified, GCP guidelines, ICD-10 CM Codes, CPT-Codes, HCPCS Codes, ICD-10 CM, CPT, HCPCS Coding, ICH guidelines, ICSR Case Processing, Interpersonal Skill, Labelling Assessment, MedDRA Coding, Medical Billing, Medical Coding, Medical Terminology, Narrative Writing, Research & Development, Technical Skill, Triage of ICSRs, WHO DD Coding

Manager, R&D – Analytical Development Laboratory (ADL)

Req ID: JR-182654
Location: Ahmedabad, Gujarat, India


🧭 Overview

At Baxter, this is where new knowledge is discovered.
Our Research & Development (R&D) teams work collaboratively across functions to innovate, develop, and introduce creative solutions that address patient needs globally.

From scientists to engineers, every contribution helps create products that save and sustain lives.


💼 Employee Benefits

  • 👨‍👩‍👧 Support for Parents

  • 🎓 Continuing Education / Professional Development

  • 💪 Employee Health & Well-being Benefits

  • 🌴 Paid Time Off

  • ❤️ 2 Days a Year to Volunteer


🌟 Success Profile

To thrive in Baxter’s R&D team, you should embody the following traits:

  • Courage

  • Action-Oriented

  • Collaborative

  • Cultivates Innovation

  • Manages Ambiguity

  • Drives Results


🎯 Purpose of the Role

The Manager, R&D – ADL will lead a team responsible for analytical method validation, transfer, and post-production studies for 505(b)(2) and Generic ANDA projects.
This role ensures analytical excellence, regulatory support, and cross-functional collaboration to bring high-quality healthcare products to market efficiently.


⚙️ Key Responsibilities

1. Analytical Leadership

  • Lead and manage ADL team activities including method validation, method transfer, and post-production studies (e.g., Freeze-Thaw, Photostability, Dilution, RLD Characterization).

  • Address and resolve analytical challenges during product transition from R&D to manufacturing.

  • Ensure compliance with cGLP, GMP, and pharmacopoeia updates.

2. Regulatory & Quality Support

  • Support Regulatory Affairs during filings and query responses related to analytical functions.

  • Provide analytical support during regulatory agency inspections at manufacturing sites.

  • Ensure timely closure of LIR, NCR, CCN, and CAPA, with appropriate corrective and preventive actions.

3. Team Development

  • Coach, mentor, and develop ADL team members to strengthen analytical capability and personal growth.

  • Promote a culture of ownership, accountability, and continuous improvement.

4. Collaboration

  • Partner with external organizations (CROs/CMOs) for analytical testing as needed.

  • Collaborate with Project Management, Regulatory Affairs, Formulation Development, Manufacturing, and QC to ensure smooth analytical operations.


🧠 Skills & Competencies

Technical Expertise

  • Proficient in analytical method validation and transfer, pharmacopoeia compliance, and cGLP.

  • Strong understanding of analytical techniques and documentation practices.

  • Familiar with GMP and cross-functional processes.

Soft Skills

  • Excellent communication, presentation, and writing abilities.

  • Effective team management and delegation skills.

  • Strong problem-solving and decision-making abilities.

  • Ability to work independently and in multicultural environments.

  • High learning agility and adaptability to new technologies or regulatory changes.


🧩 Work Culture & Values

At Baxter, we believe that every person deserves a healthy life, regardless of who they are or where they come from.
Since our founding in 1931, this belief has guided us in redefining healthcare delivery for greater global impact.

Our team is united by our Mission to Save and Sustain Lives, built on a culture of trust, courage, and collaboration.
Here, you’ll find not just a job—but purpose, pride, and impact.


⚖️ Equal Employment Opportunity

Baxter is an Equal Opportunity Employer.
We evaluate applicants without discrimination based on race, color, religion, gender, national origin, age, sexual orientation, gender identity/expression, veteran status, or disability.


Reasonable Accommodations

We are committed to providing reasonable accommodations to individuals with disabilities.
If you require assistance during the application or interview process, please contact us with your request and contact information.


🚨 Recruitment Fraud Notice

Baxter has identified incidents of fraudulent recruitment activity.
Be cautious of individuals posing as Baxter employees or recruiters.
To learn how to protect yourself, please review our Recruitment Fraud Notice.


🏢 Work Location

Navratna Corporate Park

  • Tower A, Ground Floor

  • Tower B, 21st & 22nd Floors
    Gujarat – 380058, India


🔗 Apply Now

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💬 Hear From Our Employees

Baxter’s strength comes from its diverse community of professionals across 100+ countries, working together to innovate, manufacture, and deliver better healthcare solutions worldwide.