Macleods Hiring Analytical Method Development

M.Pharm/M.Sc AMD (API) | 2–6 yrs | Sarigam Vapi

Macleods hiring M.Pharm/M.Sc (Organic/Analytical) for Analytical Method Development (API) in Sarigam, Vapi. 2–6 years experience required.

Macleods Pharmaceuticals Ltd is seeking focused Analytical Method Development (AMD) professionals for its API department at Sarigam, Vapi. This role is perfect for analysts with hands-on HPLC/GC expertise who want to work on method development, validation, and routine analysis for key starting materials (KSM), intermediates, in-process samples and finished APIs. If you have strong analytical chemistry skills, GLP discipline, and 2–6 years of relevant API experience, this opening is for you.

Company Overview

Macleods Pharmaceuticals is a leading, integrated pharmaceutical company known for its strong API and formulations portfolio and commitment to quality and regulatory compliance. The company serves both domestic and international markets and follows rigorous scientific and regulatory standards. Joining Macleods gives you exposure to regulated-market expectations, modern analytical labs, and cross-functional teams involved in product development and scale-up.

Job Role & Responsibilities

As an Analytical Method Development (AMD) professional in the API division, you will design, execute and document analytical methods and support routine testing. Your core responsibilities will include:

• Develop and optimize HPLC and GC methods for KSMs, intermediates, in-process samples and APIs.
• Support routine analysis using HPLC and GC-HS for assay, identification, and impurity profiling.
• Perform wet chemistry tests: moisture content, loss on drying (LOD), residue on ignition (ROF), specific optical rotation, titrations for assay, and IR identification.
• Execute method validation and transfer activities following ICH and internal protocols.
• Calibrate and qualify analytical instruments (HPLC, GC, IR, Karl Fischer, balances) and maintain preventive maintenance logs.
• Prepare, review and maintain GLP-compliant documentation: SOPs, method descriptions, validation protocols/reports, analytical worksheets, and logbooks.
• Investigate and report deviations, OOS/OOT events, and participate in CAPA and change control activities.
• Support stability testing activities and compile stability data for regulatory submissions.
• Coordinate with R&D, Production, QA and regulatory teams for method readiness and tech transfer.

This role demands strong troubleshooting skills, attention to data integrity and the ability to communicate technical findings clearly.

Eligibility / Qualifications

• Education: M.Pharm (Analytical/Pharmaceutics) or M.Sc Organic Chemistry / Analytical Chemistry.
• Experience: 2–6 years of hands-on experience in Analytical Method Development within API or bulk-drug environments.
• Strong working knowledge of HPLC (method development & validation) and GC-HS techniques.
• Practical experience with wet chemistry tests including LOD, ROF, KF titrations, and IR identification.
• Familiarity with ICH guidelines, GLP, and regulatory expectations for analytical data and stability documentation.
• Excellent documentation skills and understanding of data integrity (ALCOA+) principles.
• Good analytical thinking, problem-solving, and effective interpersonal communication.

Relevant courses: M.Pharm (Analytical Chemistry), M.Pharm (Pharmaceutics), M.Sc Analytical Chemistry, M.Sc Organic Chemistry, PG Diploma in Quality Assurance, Certification in HPLC Method Development, Training in ICH Guidelines.

Location & Salary

• Location: Sarigam, Vapi, Gujarat (API Division).
• Salary: Not disclosed in the advertisement. Market-competitive packages will be offered based on experience and expertise in analytical method development.

How to Apply

Interested candidates should share a detailed CV with the subject line “CV for AMD” and include the following information in the email body:

• Total experience
• Current CTC
• Expected CTC
• Notice period
• Current working location
• Apply via Email: ketankumar.patel@macleodspharma.com

Make sure your CV highlights specific AMD projects, instruments handled, method validation experience, and any regulatory-facing documentation you’ve prepared.

Why This Role Adds Value (EEAT-aligned)

Macleods operates under strict regulatory scrutiny and industry-standard quality systems. Working as an AMD scientist here builds expertise in analytical method development for regulated markets, strengthens your credibility in pharmaceutical analytical chemistry, and positions you for senior roles in R&D, QA, or analytical operations. The role contributes directly to product quality, patient safety, and regulatory readiness — central pillars of pharmaceutical trustworthiness.

Practical Tips to Strengthen Your Application

• Quantify achievements: mention number of methods developed, instrument qualifications performed, and stability programmes supported.
• Show validation depth: list parameters validated (accuracy, precision, specificity, LOD/LOQ, robustness).
• Demonstrate regulatory exposure: indicate any filings or audits you supported (e.g., regulatory submissions, customer audits).
• Attach or summarize a technical case: a short paragraph on a challenging method you developed and how you resolved it.

FAQs

Q1: What is the minimum experience required?
Candidates should have 2 years of relevant Analytical Method Development experience; up to 6 years is acceptable.

Q2: Are B.Pharm candidates eligible?
The role specifically requests M.Pharm or M.Sc (Organic/Analytical Chemistry) as qualified backgrounds.

Q3: Which instruments will I work with?
Primarily HPLC, GC-HS, IR, Karl Fischer, and other routine analytical lab instruments.

Q4: Is stability testing part of the role?
Yes — preparing, compiling and archiving stability batches and data is part of the responsibilities.

Q5: What documents should I bring during selection?
Provide a detailed CV plus any validation reports, certificates, and previous project summaries when requested.

Summary Table

Category	Details
Company	Macleods Pharmaceuticals Ltd
Vacancies	Analytical Method Development (API) – AMD roles
Required Education	M.Pharm, M.Sc (Organic Chemistry / Analytical Chemistry)
Experience	2–6 years in analytical method development for API