Manager – Research & Development (R&D)

Job Title: Manager – Research & Development (R&D)

Industry Type: Pharmaceuticals / Biotechnology / Life Sciences

Role Category: Mid-Level – R&D Operations & Product Development

Department: Research & Development (Formulations / API / Biotech / NDDS)

Employment Type: Full-Time, Permanent

Manufacturing Location: Sikkim

Experience Range:

8 – 12 Years of experience in pharmaceutical product development, including formulation/API development, tech transfer, and regulatory support.

Salary Range (INR):

₹15 – ₹25 Lakhs per annum (depending on domain expertise and company location)

Educational Qualification:

Mandatory: M.Pharm / M.Sc / M.Tech – Pharmaceutics, Pharmaceutical Chemistry, or equivalent

Preferred: Ph.D. in relevant pharmaceutical sciences or chemical synthesis

Certifications in QbD, ICH, or Regulatory Affairs are an added advantage

Role Overview:

The Manager – R&D is responsible for planning and executing research projects related to formulation or API development for domestic and regulated markets. This role involves leading a team of scientists, ensuring technical excellence, compliance, and timely delivery of R&D milestones.

Key Responsibilities:

Lead formulation/API development activities for new and existing products

Conduct pre-formulation studies, lab trials, and scale-up batches

Manage the preparation and review of development reports, protocols, and technology transfer documents

Coordinate with QA, RA, SCM, and Production for project execution and site transfers

Ensure compliance with regulatory guidelines (ICH, WHO, USFDA, etc.)

Guide dossier documentation and provide technical input for filings (CTD, ANDA, DMF)

Monitor stability studies and analytical validations in coordination with QA/QC teams

Implement QbD and DoE approaches in product/process development

Mentor junior staff and manage timelines, costs, and resource allocation

Key Skills & Competencies:

Strong technical expertise in either formulation development or API synthesis

Sound understanding of cGMP, ICH, and regulatory requirements for global markets

Familiarity with QbD principles, DoE tools, and tech transfer processes

Proficiency in documentation for regulatory submissions (CTD modules, stability, validation)

Project management, team leadership, and cross-functional collaboration

Problem-solving mindset with focus on innovation, compliance, and efficiency