We are looking for a talented Manager, Formulation Development to join us. At Hikma you ll be supported by a culture of progress and belonging where people are encouraged to develop, wellbeing is prioritised and our inclusive approach values contributions from all. We re seeking candidates who embody our values: Innovative, driven to keep learning; Caring, genuinely compassionate in their work; and Collaborative, eager to solve problems together.

If you want to be part of a team that cares about impact, this is the place for you.

Job Purpose:

The Manager, Formulation Development will lead formulation development activities for oral solid dosage forms and other suitable dosage forms from concept to commercialization. The role requires strong technical expertise in QbD-based product development, execution of registration/submission batches, technology transfer, regulatory support, troubleshooting, and leadership of a high-performing team. The incumbent will collaborate closely with Analytical Development, Regulatory Affairs, Quality, Manufacturing, Supply Chain, and Project Management teams to ensure timely and successful product development and regulatory submissions.

The candidate should Secures and manages resources to meet project objectives within defined time, cost, and quality parameters. Introduces innovative methods and solutions to address challenges and improve performance. Ensures that standards and processes including SOPs, cGMP, and H&S are developed, maintained, and effectively implemented. Oversee departmental performance, aligning scientific initiatives with organizational goals. Develops staff capabilities and ensures resource optimization. Operates independently within global networks and leads cross-functional teams to align efforts with strategic goals.

Key Responsibilities:

Formulation Development & Product Lifecycle Management

Lead formulation development activities for generic (Regulated markets such as USA, Europe, Canada, MENA etc) and brand products from feasibility through dossier filing and commercialization.

Design and develop robust, scalable, and commercially viable formulations using scientific and risk-based approaches.

Apply Quality by Design (QbD) principles throughout product development.

Establish Quality Target Product Profile (QTPP), Critical Quality Attributes (CQAs), Critical Material Attributes (CMAs), and Critical Process Parameters (CPPs).

Utilize Design of Experiments (DOE) and statistical tools to optimize formulations and processes.

Support development of differentiated and value-added product opportunities.

Regulatory Submission Support

Drive preparation and review of formulation-related sections for ANDA and global generic submissions .

Ensure adequacy and compliance of development reports, product development documents, and regulatory filing documentation.

Provide scientific justification and responses to regulatory deficiencies, agency questions, and information requests.

Represent Formulation Development during regulatory inspections, audits, and agency interactions as required.

Submission Batches & Technology Transfer

Lead execution and monitoring of exhibit, registration, scale-up, validation, and submission batches.

Ensure effective transfer of technologies from R&D to manufacturing sites.

Collaborate with Manufacturing, Engineering, Quality Assurance, and Validation teams to ensure successful commercialization.

Resolve scale-up and manufacturing challenges through scientific evaluation and risk mitigation.

Technical Leadership & Troubleshooting

Provide technical leadership in resolving formulation, process, scale-up, and commercial manufacturing challenges.

Investigate product performance issues and implement scientifically sound corrective actions.

Lead root cause investigations and troubleshooting activities related to formulation and process performance.

Evaluate and implement innovative formulation technologies for pipeline enhancement.

Innovation & Technology Advancement

Continuously assess emerging technologies and novel drug delivery/formulation platforms.

Recommend innovative approaches to improve product performance, development timelines, and commercial success.

Drive knowledge sharing and adoption of current industry best practices.

Cross-Functional Collaboration

Lead multi-disciplinary project teams and ensure alignment across functions.

Collaborate effectively with Analytical Development, Regulatory Affairs, Quality, Manufacturing, Procurement, Project Management, and Commercial teams.

Drive project execution through proactive communication, risk assessment, and stakeholder management.

Foster a culture of partnership and accountability across departments.

People Leadership

Lead, mentor, and develop formulation scientists and junior team members.

Create a learning-oriented environment that supports technical growth and succession planning.

Encourage innovation, scientific rigor, accountability, and continuous improvement.

Build team capability through coaching, performance management, and development planning.

Promote employee engagement and a culture of care, respect, and collaboration.

Desired Candidate Profile

We are looking for candidates with relevant pharmaceutical formulation development experience with significant exposure to Generic/Brand product development and submissions whose experience and skills align closely with the qualifications outlined below:

Minimum Qualifications

Advanced degree in Pharmacy, Chemistry, Pharmaceutical Sciences, Chemical Engineering, or a related scientific discipline (PhD/Masters or equivalent preferred).

Minimum Experience

PhD degree with 8 - 10 years of work experience in Formulation Development

Master s degree with 10 - 12 years of work experience in Formulation Development

Bachelor s degree with 12 - 15 years of work experience in Formulation Development

Minimum Achievements:

Substantial submissions for highly regulated markets such as USA, Europe, Canada

Number of MENA submission: 25

Core Competencies

Problem Solving & Decision Making

Applying Good Manufacturing Practices (GMP)

Applying Standard Operating Procedures (SOPs)

Corrective and Preventive Action- (CAPA)

Good Laboratory Practices (GLP)

Strategic leadership and innovation management

Deep scientific and technical expertise in pharmaceutical development

Regulatory and quality compliance knowledge

Portfolio and project governance

Financial and operational management

Stakeholder engagement and executive communication

Talent development and organizational leadership

Continuous improvement and change leadership

Technical Competencies

Extensive experience in ANDA/Generic product development and regulatory submissions.

Strong exposure to execution of registration/submission batches and commercial scale-up.

Proven experience in Technology Transfer to manufacturing sites.

Demonstrated experience in handling and responding to regulatory agency queries and deficiencies.

Strong knowledge and practical application of QbD principles.

Hands-on expertise in Design of Experiments (DOE) and statistical data analysis.

Knowledge of pharmaceutical development regulations and cGMP requirements.

Experience with risk assessment tools and product lifecycle management.

Exposure to novel formulation technologies, platform approaches, and differentiated dosage forms.

Strong troubleshooting and problem-solving capabilities.

Leadership Competencies

Proven experience managing and developing teams.

Strong mentoring and people nurturing mindset.

Ability to influence and lead without authority across matrix organizations.

Excellent stakeholder management and communication skills.

Strong project management and prioritization capability.

Demonstrated ability to lead cross-functional teams collaboratively.