Head of Research & Development (R&D) - Formulation and Analytical Development

Job Title:

Head of Research & Development (R&D) - Formulation and Analytical Development



Company Overview:

Orbit Pharma Limited is a rapidly expanding, privately owned UK-based pharmaceutical company focused on the development and marketing of high-quality, specialist generic and value-added medicines. With a commitment to excellence in drug product development, we provide end-to-end pharmaceutical solutions tailored for regulated markets worldwide, including the US, EU, Canada, and others. Headquartered in the UK, Orbit Pharma operates globally, leveraging innovation and regulatory expertise to deliver differentiated products that meet stringent international standards.orbitpharma.ukuk.linkedin.com

Job Location:

Ahmedabad, India (with oversight of multiple sites)

Job Summary:

We are seeking an experienced and dynamic R&D Head to lead our Formulation and Analytical Development team. This role is pivotal in driving the development of value-added medicines for highly regulated markets such as the US, EU, Canada, and others. Based in Ahmedabad, the successful candidate will manage multiple sites, oversee diverse projects, and foster a result-oriented team environment. The focus will be on innovative formulations including solid dosage forms, sterile products, nasal sprays, transdermal patches, and other differentiated medicines. This position reports directly to senior leadership and plays a key role in ensuring compliance, efficiency, and scientific excellence in our R&D operations.

Key Responsibilities:

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Leadership and Team Management: Lead a multidisciplinary R&D team focused on formulation and analytical development, promoting a result-oriented culture. Manage talent acquisition, training, performance evaluations, and career development to build high-performing teams across multiple sites.

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Project Management: Oversee multiple concurrent projects from concept to commercialization, ensuring timelines, budgets, and quality objectives are met. Coordinate cross-functional collaboration with manufacturing, quality assurance, regulatory affairs, and external partners.

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Formulation Development: Drive the design, development, and optimization of value-added medicines, with a strong emphasis on solid dosage forms (e.g., tablets, capsules), sterile injectables, nasal sprays, transdermal patches, and other differentiated delivery systems. Incorporate innovative technologies to enhance bioavailability, stability, and patient compliance.

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Analytical Development: Supervise analytical method development, validation, and transfer activities to support formulation efforts. Ensure robust analytical strategies for

stability testing, impurity profiling, and bioequivalence studies in line with ICH and FDA guidelines.naukri.com

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Regulatory Compliance: Ensure all R&D activities comply with USFDA, EMA, Health Canada, and other global regulatory requirements. Prepare and review technical documentation for IND/NDA/ANDA submissions, including CMC sections.

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Innovation and Strategy: Identify opportunities for product differentiation through novel formulations and technologies. Conduct feasibility studies, risk assessments, and technology transfers to manufacturing sites. Stay abreast of industry trends, patents, and competitive landscapes to inform strategic R&D decisions.

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Resource and Site Management: Manage R&D facilities in Ahmedabad and coordinate with multiple sites globally. Optimize resource allocation, including equipment, budgets, and personnel, to maximize efficiency and output.

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Collaboration and Reporting: Foster partnerships with academic institutions, CROs, and CMOs. Provide regular updates to executive leadership on project progress, milestones, and challenges.

Qualifications and Experience:

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Education: PhD or Master's degree in Pharmaceutical Sciences, Chemistry, or a related field. Advanced certifications in regulatory affairs or project management are a plus.

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Experience: Minimum 15+ years in pharmaceutical R&D, with at least 8-10 years in a leadership role overseeing formulation and analytical development. Proven track record in developing solid, sterile, nasal spray, transdermal patch, and differentiated medicines for regulated markets (US, EU, Canada, etc.). Experience managing multiple sites, projects, and teams is essential

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Skills:

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Deep expertise in formulation technologies, analytical techniques (e.g., HPLC, GC, dissolution testing), and scale-up processes.

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Strong knowledge of cGMP, ICH guidelines, and regulatory submissions.

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Excellent project management skills with experience in tools like MS Project or Agile methodologies.

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Leadership abilities to inspire result-oriented teams and drive innovation.

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Proficiency in data analysis, problem-solving, and strategic planning.

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Personal Attributes: Result-driven, with a passion for innovation and a collaborative mindset. Ability to thrive in a fast-paced, multicultural environment.

What We Offer:

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Competitive salary and benefits package, including performance bonuses and relocation support if needed.

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Opportunities for professional growth in a global pharmaceutical leader.

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A collaborative work environment with state-of-the-art facilities in Ahmedabad.

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Contribution to meaningful healthcare advancements through value-added medicines.

Orbit Pharma Limited is an equal opportunity employer. Interested candidates should submit their resume and cover letter to ashvini.nalawade@orbitpharma.uk We look forward to welcoming a visionary leader to our team!