Deputy Manager

Position / Title: -
Deputy Manager / Manager – Analytical Development Laboratory

Gender
: Male

Educational Requirement:
Science Graduate

CTC Offered –
Approx. up to 10 LPA ( Can we keep budget range from 10 Lpa – 20 Lpa)

Experience:
Around 15 years in API Analytical Development Laboratory)

Location:
Boisar (Factory)

Position Summary:

A Quality Control (QC) Analytical Development Laboratory Manager in an API manufacturing company oversees day-to-day lab operations, ensuring compliance with cGMP and regulatory guidelines by managing team activities, equipment, documentation, and the testing of raw materials, intermediates, and finished APIs. Key responsibilities include team leadership and training, analytical method support, data integrity, and regulatory interactions to maintain high product quality standards.

Key Responsibilities

1. API Analytical Method Development & Validation

· Design, develop, and validate robust analytical methods for Active Pharmaceutical Ingredients (APIs).

· Ensure compliance with ICH guidelines and regulatory standards during method development.

· Troubleshoot and optimize existing analytical methods for better accuracy, precision, and reproducibility.

· Maintain detailed documentation of method development and validation reports.

2. Analytical Studies & Support

· Conduct and oversee stability studies, impurity profiling, and degradation studies.

· Ensure timely generation, review, and approval of analytical data for regulatory submissions and R&D requirements.

· Provide analytical support for scale-up, process development, and technology transfer.

3. Dossier Preparation & Regulatory Compliance

· Prepare and review analytical sections of dossiers (DMF, ANDA, CTD formats, etc.).

· Support regulatory teams by providing complete analytical data for submissions and audits.

· Ensure strict compliance with global regulatory requirements (USFDA, EMA, MHRA, etc.).

4. Manpower & Laboratory Management

· Lead and mentor a team of analysts and scientists within the Analytical Development Laboratory.

· Allocate work, monitor progress, and ensure timelines are met for all analytical projects.

· Conduct training and skill development programs to enhance team capabilities.

· Ensure adherence to GLP (Good Laboratory Practices), safety, and quality standards in the lab.

5. Patent & Literature Survey

· Perform comprehensive patent and literature surveys to identify existing analytical methods.

· Evaluate suitability of reported methods for in-house use and implement optimized versions.

· Ensure developed methods are non-infringing and innovative while aligning with regulatory expectations.

6. Collaboration with R&D

· Work hand-in-hand with the R&D department to support formulation and process development.

· Provide analytical insights during scale-up and validation batches.

· Actively participate in cross-functional project meetings to ensure analytical requirements are addressed proactively.

7. Continuous Improvement & Innovation

· Drive continuous improvements in analytical practices by adopting latest technologies and instrumentation.

· Explore automation and digital tools to improve laboratory efficiency and data integrity.

· Contribute to organizational growth by supporting new product development projects.

Desired Candidate Required Skills and Qualifications:

·
Leadership:
 The ADL manager needs strong leadership skills.

·
Communication:
 The ADL manager needs to be able to communicate effectively with employees, supervisors, vendors, and customers.

·
Problem-solving:
 The ADL manager needs to be able to analyse technical problems and come up with solutions.

·
Attention to detail:
 The ADL manager needs to be detail-oriented
.
Sound knowledge of ICH guidelines, pharmacopeias, and global regulatory requirements

·
Technical skills:
 The ADL manager needs to have knowledge of testing methods, data analysis, and quality management systems. Strong technical expertise in instrumental techniques (HPLC, GC, LC-MS, FTIR, UV, NMR, etc.).

About Us :

Royal Pharma is a trusted pharmaceutical company with global recognition. With our USFDA Approved facility and WHO GMP Certification, we ensure the highest standards of quality, safety, and efficacy. We are also ISO 9001:2015, ISO 14001:2015, ISO 45001:2018 Certified. With over 15 years of experience, we specialize in advanced intermediate and API manufacturing. Collaborating with top multinational companies, we have expanded our reach worldwide.