- Company Group has head office in Kuala Lumpur, Malaysia and has its office in Europe & USA. Our company is a young and innovation driven organisation that engages in the discovery, research and development, validation and commercialization of unique natural compounds with therapeutic properties in the nutritional, cosmeceutical, animal health and pharmaceutical markets. We are focused on innovative strategies that can generate first-in-class compounds representing real advancements in scientific and medical thinking.
Due to the dynamic growth of our global business activities, we are seeking a highly energized and resourceful professional for this role. Company offers significant career development opportunities to successful candidates
- Position 1: TECHNICAL DEVELOPMENT R&D MANAGER (Formulation)
Identify new technologies and/or manufacturing partners to meet business needs. Engages and networks with experts to bring about innovations/new ideas and opportunities. Leads R&D formulation development projects and ensure project objectives and budget are met. Leads and engages with respective stakeholders to collectively resolve the formulation/technical setback during the galenic development process. Supports commercial team in the validation of contract manufacturing cost based on manufacturing technology for new pipeline products, taking into consideration leverage as well as manufacturing complexity where applicable. Coaches and develop subordinates on technical/galenic development skills and business acumen.
Bachelors Degree in Science, Pharmacy or Pharmaceutical Engineering. At least 6 8 years of working experience preferably in a Pharmaceutical Manufacturing environment (preferably with oral solid dosage i.e. tablet, capsule, powder sachet, softgel manufacturing experience) Knowledge in oral controlled release of actives, dietary supplements Sound engineering/technical knowledge with regards to manufacturing equipment such as blender, tablet press, coating machine, softgel/hardgel encapsulation machine, powder/liquid sachet filling, blister and cartooning machine etc. Knowledge with equipment qualification, process validation and cleaning validation would be highly regarded. Working experience with Asia-Pacific and Europe will be highly regarded.
- Position 2: SCIENTIFIC AND MEDICAL AFFAIRS MANAGER
- The Scientific and Medical Affairs Manager assumes overall responsibility in providing balanced, evaluated information and advice on the clinical use of the products being developed and commercialized by Company Group. The incumbent ensures that Company products efficacy and safety is substantiated by well-conducted pre-clinical and clinical research to meet the commercial, scientific and regulatory needs. The incumbent also supports the commercial and scientific efforts in marketing of Companys products in compliance to the regulatory framework and ethical guidelines.
1. Scientific and Medical Affairs
Provide professional advice and information for scientific and medical enquiries internally and externally arising from commercial, scientific and regulatory needs
Medical review and approval of product labels, promotional materials and medical information & communication materials according to the relevant guidelines
Support the marketing and business development team in compiling and analyzing product information
Represent Company in national and international scientific events
Maintain a comprehensive scientific and medical information database for commercialized products for the reference of scientific and commercial teams
Support commercial and marketing teams in KOL programs where applicable
2. Clinical Research
Assume overall responsibility to manage all aspects of clinical research projects, including planning and budgeting, protocol development, trial registration, ethical approval, CRO selection and management, trial monitoring, trial results review, reporting and publication
Ensure clinical trials are designed according to scientific and medical best practices through adequate, meticulous and critical review of available literature and knowledge
Ensure all clinical research projects are well managed, meeting the commercial, scientific and regulatory needs within allocated human and financial resources Recognize area of risk and potential in clinical research and provide professional and timely advice to the management to maximize return of investments and minimize risk of failure.
3. Regulatory Compliance
Ensure medical reviews are conducted in compliance to labelling and advertising regulations within relevant country specific and international regulations
Ensure clinical trials are conducted in compliance to GCP, medical device or other applicable regulatory guidelines
4. Managerial Functions
Leading the functional team by developing systems, process and documentation to manage projects and expenses
Progress reporting to relevant stakeholders
Coaching, training and development of team members
Candidates must possess a recognized Medical Degree (MBBS) or be a registered pharmacist.
Minimum of 5 years of relevant working experience in medical affairs or medical information services and/or clinical research operations.
Service oriented approach, flexible and proactive towards meeting customers needs
Excellent questioning, listening and communication skills
Ability to maintain confidentiality and professionalism
Confident, assertive and dependable with passion, energy and drive for success
High level proficiency in English Language (both written & spoken)
Good time management skills
Attention to detail
Ability to handle multiple tasks and efficiently prioritize work
Position 3: RESEARCH & DEVELOPMENT MANAGER
The R&D Manager reports to the Senior Manager of Research and Development, and works in close collaboration with marketing team and relevant project manager. The incumbent is overall responsible for all aspects of new product development under the assigned category. Manages the end-to-end process of idea conceptualization to product commercialization, ensuring product development activities are conducted in alignment with the business, financial and corporate growth objective. The incumbent leads her team in planning, implementing, monitoring and controlling of the R&D projects in alignment with the scientific, marketing, financial, and corporate growth objectives.
Leadership & Management - As leader for the assigned product categories, the incumbent will guide, manage and supervise the team to achieve the department and the business goals.
Compound Research & Development
Supports the Senior Manager and Head of Department in continuous innovation of new compounds/products for a healthy product pipeline.
Leads the assigned team of R&D Assistant Managers and Associates and manages the planning, execution and control of the complete compound R&D process, which encompasses the following phases over a medium to long term period.
Pre-Clinical Research - From the early compound research and development phase, the incumbent further ensures plans are in place for validating new compounds efficacy and safety through solid scientific research.
Product Development and Commercialization
The incumbent is responsible in developing new products for commercialization to meet business objectives.
He/she is responsible to deliver the results through by performing following duties,
Concept Feasibility - Creates and identify the most outstanding, creative and profitable opportunity for a product to serve the market /customers.
Product Strategy - Responsible to create product strategies to deliver most effective and profitable solutions for the opportunities identified.
In charge of overall Product Development Cycle through concept, development, prototype/sample and production stages.
Responsible to manage and supervise product development projects including vendor management, project management, technical documentation and marketing/promotional literatures.
Responsibility/support for other department - Manage the integration activity with other departments including clinical trial, marketing, total quality and regulatory affairs.
Ensuring proper confidentiality of projects internally and externally.
Establishes NDA and working agreements with collaboration partners.
Bachelors, Master or PhD degree in a Life Science discipline; (Pharmacy, Nutrition, Food Technology, Biotechnology, Bio-Medical, Bio-Chemical, Applied Sciences)
6-8 years related experience in a healthcare, nutraceutical or food industry, with 1-2 years supervisory experience.
Good knowledge of ingredients in nutraceuticals/functional food industry.
Product development and project management skills are pre-requisites.
Proven track record in managing a R&D team
Being well versed with industry and market trends and having established a network of technology partners and ingredient suppliers within the industry would be an added advantage.
- Email Address: firstname.lastname@example.org