Sr. Manager, R&d

4 weeks ago

Riyadh, Saudi Arabia Hikma Pharmaceuticals PLC Full time

**Job Purpose**:
Person will be responsible for Formulation and Process development following Quality by Design (QbD) approach, setting control strategies for CPPs and CMAs for seamless Process Scale-Up and Technology Transfers, Ensuring New Product Launches (NPI) on time, Commercial Trouble Shooting, Continuous Process Improvement, SOP standardization and Developing Team. Takes responsibility for technical decision making for formulation related issues on the team. Position involves delegating and executing assigned tasks within the constraints of the published timelines. Responsible for the design and execution of non-routine, complex processing, and training of laboratory personnel in areas of expertise. Setting policies and procedures and recommending improvements to operational processes and procedures.

**Description**
- Developing the R&D work plan; assigning work activities, projects, and programs, monitoring workflow, reviewing, and evaluating work methods and procedures, and directing such activities to serve the Department's goals and plans.
- Proposing plans and programs that boost the efficiency of the R&D.
- Meeting Department Goals and Seamless R&D Daily Operations.
- Increase number of quality filings and launches from site.
- Responsible for technology transfer for site transfer and development project as per department need.
- Preparing and presenting all necessary reports in a timely and accurate manner to keep top management informed on the process development work.
- Smooth technology transfer and Product development within stipulated timelines.
- Meeting Performance expectation of the Management
- Ensuring implementation of the R&D function plans in compliance with Hikma’s Policies and Procedure.
- Complies with all relevant Safety, Quality, Health and Environmental procedures to ensure a healthy and safe work environment.
- Ensuring R&D team workings in 100% compliance of Hikma’s Standards.
- Working in 100% compliance with Hikma’s Safety, Quality and Regulatory policies and Procedure
- Prepare Budget Plan for R&D Expense related to Product Development till filing, Capacity Enhancements and Capability Building.
- Reviewing & managing expenses within official budget allocations

Financial Variance versus Budget
- Developing and managing the team, which can develop current and potential products that meet patient’s need and regulatory guidelines.
- Reviewing and planning training sessions on the Standard Operating Procedures (SOP) list and its updates for the R&D team.
- Team meets their development need and meeting performance goals.
- R&D team works in compliance with statutory and Regulatory requirement.
- Recommending improvements to the Site by incorporating new equipment and technology to help to scale-up more complex products
- Implement process improvement program like developing new manufacturing procedures/ processes that increase batch size and minimize processing time, as well as minimize raw material costs.
- Handling and responding to regulatory agency deficiencies and providing technical documents as needed.
- Increased number of Development, Technology transfer, Filing and Launches of Complex products.
- Cost and Time Saved based on improvement plan.
- No Major deficiency, which can impact the launch date.

**Qualifications, Experiences, & Skills which is essential to do the job effectively**:
**Qualifications***
- Bachelors or Master’s or Doctorate in Pharmaceutical Science

**Experiences**
- Minimum 12 years of Relevant Industry Experience with Ph. D. Degree
- Minimum 15 Years of Relevant Industry Experience with master’s degree
- Minimum 17 Years of Relevant Industry Experience with bachelor’s degree

**Skills**
- Expert in Product Development and Technology Transfer.
- Full comprehension of pharmaceutical lifecycle management, knowledge of regulatory requirements, and knowledge of technology trends.
- Demonstrated Project/Program management skills.

**Behavioral Competencies**
- Initiative & Drive for results - Level 3
- Change & Innovation - Level 3
- Communication & Influence - Level 3
- Developing & Empowering others - Level 3
- Problem Solving & Decision Making - Level 3
- Strategic and Analytical Thinking - Level 3
- Conflict Management - Level 3
- Coaching and Mentoring -Level 3
- Decision Making-Level 3
- Cost Consciousness -Level 3
- Work Ethics and Values-Level 4

**Functional Competencies**
- Data Analysis - Level 3
- Computer Skills
- Level 3
- Drug Handling
- Level 3
- Drug Registration Regulation-Level 3
- English Language-Level 3
- Cost Estimation and Analysis - Level 3
- Knowledge of Pharmaceutical Process, Research Methodologies, Technical Writing, Materials, Equipment and Manufacturing process -Level 3
- Project Management-Level 3

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