Sr. Manager – Research & Development (R&D)

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

Industry Type: Pharmaceuticals / Life Sciences / Biotechnology

Role Category: Mid-Senior Level – R&D Management

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

Employment Type: Full-Time, Permanent

Manufacturing Location: Visakhapatnam

Experience Range:

12 – 18 Years of hands-on experience in pharmaceutical R&D, with specialization in formulation/API development, scale-up, and regulatory filings for regulated/semi-regulated markets.

Salary Range (INR):

₹25 – ₹40 Lakhs per annum (depending on specialization, experience, and company size)

Educational Qualification:

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

Preferred: Ph.D. in Pharmaceutics / Chemistry / Drug Delivery

Certifications in QbD, Regulatory Affairs, or Project Management are desirable

Role Overview:

The Sr. Manager – R&D is responsible for leading product development projects, ensuring timely completion of formulation/API development, scale-up, validation, and technical documentation in line with regulatory and business requirements.

Key Responsibilities:

Manage end-to-end development of pharmaceutical products – formulation, analytical, or API

Plan and execute lab trials, exhibit batches, and technology transfers to manufacturing

Ensure implementation of QbD, DoE, and ICH guidelines in development processes

Coordinate with cross-functional teams for dossier filing, stability studies, and product scale-up

Lead preparation and review of technical documentation: protocols, reports, CTD modules

Liaise with RA team for global submissions: ANDA, DMF, CTD dossiers

Mentor junior scientists and manage team performance and development

Support audit readiness by maintaining documentation and compliance standards

Drive innovation in formulation techniques or synthetic process optimization

Monitor project timelines, cost targets, and resource planning for development projects

Key Skills & Competencies:

In-depth knowledge of formulation or API development techniques

Familiarity with global regulatory frameworks (USFDA, EMA, WHO, TGA, etc.)

Strong understanding of QbD, DoE, ICH, and cGMP guidelines

Proficient in technical documentation, stability study design, and regulatory filing support

Ability to manage and prioritize multiple projects simultaneously

Team leadership, scientific acumen, and result-oriented mindset

Experience in handling audits and client due diligence visits