R&D & Product Development Manager
Amman, Jordan
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Valuing People. Science. Life - At Labatec Pharma, we are committed to deliver medicines that help to improve quality of life for patients around the world by meeting the needs of thehospital and retail sectors. Wecollaborate all together to deliver outcomes which add significant valueto our clients’ projects and the community as a whole. Our people are at the center of Labatec Pharma.
Labatec is looking for talented individuals to join its growing team! Join us!
We are currently looking for an R&D and Product Development Manager to join our team. This person will report directly to the General Manager and be responsible for new product processes and technology transfer, working in direct collaboration with other departments.
Your key responsibilities
* Lead the co-development activities with external development partners, working closely to transition newly developed products from the development stage to full commercial manufacturing scale at the targeted manufacturing site. Collaborate in-house as needed to support internal developments and ensure seamless integration into manufacturing operations internal developments and/or with development partner(s), if selected, to bring the newly developed products from their development stage to the Manufacturing commercial scale through the targeted manufacturing site.
* Collaborate with cross-functional teams, including production, quality assurance/ control, regulatory affairs to develop, prepare for registration, and transfer products for the targeted markets, according to the corporate technical department system.
* Develop and/or improve the targeted product analytical methods from the concept phase up to analytical method validation, following international standards and all health authorities' expectations.
* Work closely with the registered products technology transfer from and to Labatec Pharma S.A.'s current & future manufacturing sites or partners.
* Develop and lead execution of technical runs/design of experiments (DoE) with data analysis and recommendations such as Conduct trials (e.g., engineering batches, validation batches).
* Support and implement corporate technical department validation procedures, including creating proper documentation for concept, prototyping, initial design phase, and final design process validation phase, in line with the specific validation requirements of each country's regulatory teams and/or health authority, according to the corporate technical department system.
* Draft, prepare, and implement corporate validation protocols and validation approach and applied work procedures in conjunction with manufacturing, regulatory, and quality teams.
* Prepare and provide registration elements, technical support, and consultation for registration activities, including new submissions and deficiencies responses, up to approval.
* Engage in troubleshooting and recommendation/ modifications to existing product formulas and/or processes, for improvements in quality, and product cost.
* Maintain a commitment to quality and compliance in all R&D activities, upholding the highest industry standards to ensure the safety and efficacy of our products.
* Preserve meticulous records of experiments, results, and procedures, safeguarding invaluable intellectual property and supporting the continuous improvement of our processes.
* Oversight of equipment selection, sizing calculations, and P&ID development against client
* Preparation of tech transfer supporting documentation, including knowledge transfer packages, protocols, gap analyses, and risk assessments.
* Management and/or preparation of operational documentation, including batch records, standard operating procedures (SOPs).
* Support capacity planning activities, define project scope, timelines, and deliverables.
We are looking for
* Strong knowledge in various oral dosage forms and corresponding unit operations such as and not limited to dry or wet granulation, blending, tableting, spray-drying, film, and sugar coating.; knowledge in other pharmaceutical dosage forms is a plus.
* Strong formulation, tech transfer and project management skills with 3 years of current work experience.
* A minimum of 7 years of experience in the pharmaceutical industry.
* Proven expertise in technical transfer processes, ensuring the transition of knowledge and processes.
* Experience executing projects in a GMP-regulated environment is considered a strong asset.
* Management of projects, systems, clients, and business relationships.
* Highly energetic, self starter with strong sense of purpose to grow and contribute
* Excellent collaboration and communication skills to work effectively with cross-functional teams.
* Proficiency in written and spoken English with the ability to communicate clearly with clients.
* Ability to travel up to 50% of the time.
We will offer you
* A collaborative and friendly environment within a human-sized company
* An established Company operating with agility
* Continuous professional training to develop your potential
* A rewarding compensation & benefits package
About us
Labatec is a Swiss-based private pharmaceutical company headquartered in Geneva, Switzerland. Our company has 60+ years experience in the production and supply of medicines to 11 countries comprising Switzerland, the Middle East and North Africa and expanding today in Europe. We aim to be a leading licensing partner in generic and specialty innovative medicines in our markets with an extensive portfolio of 70+ products in both the retail and hospital segments. We serve our communities by developing, manufacturing, and distributing high quality medicines covering major therapeutic areas such as musculo-skeletal, ophthalmology, anaesthetics, oncology, anti-infectives and women’s health.
For more information, please visit our website: http://www.labatecpharma.com/about-us/
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