Assistant Manager

Company: Acme

Location: R&D Centre, Science City, Ahmedabad

Designation: AM/Manager

Reporting To: Senior Management

1. Job Purpose

To lead, manage, and strengthen the Analytical Development Laboratory (ADL) function by overseeing method development, method validation, analytical operations, compliance, and team capability building. The role is responsible for ensuring timely analytical support for formulation development, technology transfer, regulatory submissions, and commercial manufacturing requirements.

2. Key Responsibilities

A.

• Lead the development, optimization, and validation of analytical methods for solid oral dosage forms (tablets, capsules, pellets, etc.).
• Ensure analytical methods are scientifically sound, robust, reproducible, and compliant with ICH, USP, EP, and regulatory guidelines.
• Review and approve analytical method protocols, reports, and related technical documents.
• Troubleshoot analytical issues and provide guidance to the team on complex testing problems.

B. Instrumentation & Technical Expertise

• Hands-on expertise in HPLC, Dissolution apparatus, UV, GC (if applicable), and other routine analytical instruments.
• Oversee calibration, qualification, and preventive maintenance of instruments as per SOPs.
• Ensure adherence to Good Laboratory Practices (GLP).

C. Team Leadership & Department Management

• Lead, supervise, and mentor the ADL team with effective delegation and performance monitoring.
• Provide technical training, competency development, and ensure continuous skill enhancement of team members.
• Manage department activities independently, including resource allocation, scheduling, and workload planning.
• Maintain discipline, compliance, and a culture of quality and safety within the department.

D. Documentation & Compliance

• Ensure compliance with internal SOPs, cGMP/GLP requirements, and regulatory expectations.
• Oversee preparation and review of analytical documents including raw data, COAs, development reports, validation reports, SOPs, and stability study reports.
• Ensure data integrity across all analytical operations and maintain audit-ready documentation.

E. Cross-functional Collaboration

• Work closely with F&D, QA, QC, Regulatory Affairs, and Production to provide analytical support for product development and scale-up.
• Support technology transfer, exhibit batches, stability studies, and regulatory query responses.
• Participate in technical discussions, project review meetings, and decision-making for analytical strategy.

F. Project & Timeline Management

• Plan and execute analytical activities as per project timelines.
• Ensure timely completion of method development, validation, and routine analysis deliverables.
• Manage budgeting, procurement, and inventory of chemicals, standards, consumables, and instruments.

G. Audit & Regulatory Support

• Ensure readiness for internal/external audits including USFDA, MHRA, WHO, and customer audits.
• Provide analytical technical support during audits and respond to audit observations where required.

3. Mandatory Requirements (Experience & Skills)

• Minimum 7+ years of experience in Analytical Development for solid oral dosage forms.
• At least 5+ years of strong experience in analytical method development and validation.
• Hands-on expertise in HPLC, Dissolution, and other analytical instruments.
• 4–5 years of experience leading teams in the ADL department.
• Proven capability to handle the ADL function independently, including administration, team training, and technical oversight.
• Strong understanding of ICH, GLP, cGMP, and pharmaceutical regulatory guidelines.
• Excellent documentation, communication, and problem-solving skills.

4. Education

• M.Pharm / M.Sc (Pharmaceutical Chemistry, Analytical Chemistry or related specialization).
• Additional training or certifications in analytical techniques will be preferred.

5. Competencies & Behavioural Skills

• Leadership & team management
• Technical expertise in analytical sciences
• Strong decision-making and troubleshooting capability
• Quality, compliance, and data integrity mindset
• Effective communication and cross-functional coordination
• Ability to work under timelines and manage multiple projects

  Role & responsibilities

Preferred candidate profile