Job Description

About us Novugen is a wholly owned subsidiary company of a UAE-based group, SciTech International. With over 30 years of experience in the healthcare industry, the company is equipped with vast experience in venturing into strategic healthcare businesses and development of world-class healthcare facilities around the globe. We bring hard-to-source and technology intensive products to the market. Our manufacturing facility in Bandar Enstek, Negeri Sembilan is the FIRST USFDA approved pharmaceutical manufacturing facility in Malaysia and the only in Southeast Asia. We are also the first pharmaceutical company in the region to be vertically integrated from API to Finished Products R&D and manufacturing. The people behind Novugen are professionals coming from diverse backgrounds and nationalities from all over the world, working together to achieve one common goal. We strive to innovate new concepts to accelerate the launch of pharmaceuticals that lack robust generic alternatives due to their complexity. Our vision is to be the largest and fastest growing pharmaceutical company in Southeast Asia by 2025, competing in global markets. Through our passionate teams and continuous investment in R&D, we aim to provide early access to affordable medicine of the highest quality. This is our commitment to change lives worldwide. Overall: The Associate Manager, Formulation will oversee Formulation Development team and optimizing drug formulations that meet regulatory standards, ensure product stability and enhance therapeutic effectiveness. Job Responsibilities: The candidate must have high level of expertise is designing, developing & optimization of generic products for regulated & semi-regulated markets. Candidate should be able to deliver products with minimal support or supervision and should have a successful track record of completing allotted projects. Designing product development strategies based on Literature search, product intelligence and patent landscape search. Pre-formulation studies, formulation development, execution of developmental batches and process optimization of pharmaceutical products for global filings following QbD principles. Development and identification of bio relevant and discriminatory dissolution media by in-depth evaluation of formulation composition and process of manufacturing. Writing & reviewing product development reports, QbR, QoS and other regulatory submission documents. Responding to regulatory/partner/customer queries in timelines decided by HOD/project manager. Writing /reviewing standard operating procedures (SOPs), Specifications, and standard test procedures for drug substances & drug products. Preparation/review and approval of documents for the Technology Transfer and regulatory submission by interfacing with different teams including quality, regulatory and production. Plan and execution of pilot bio/scale up and exhibit batches and monitor stability data of the drug product. Collaborate with Process Development and Manufacturing teams to support process optimization, capacity improvement, and scale-up activities. Provide technical support for change management, investigation, CAPA, risk management, control strategies and related activities. Lead technical inputs for investigations and regulatory inspections. Application of scientific and engineering principles to develop process understanding and scale up product from laboratory to commercial scale. Deficiency response for all geography within the stipulated timeline. Risk assessment, OEB calculation, containment strategy & manufacturing process of highly potent / oncology drugs. To work with CFTs on financial forecasts and budgets as & when required. Manage, coach, mentor, and motivate employees for outstanding performance. Candidates having experience in developing and scaling up Spray drying or Wurster process/ designing and getting success in BE study for SR or XR dosage forms development for the regulated market will be preferred. Job Requirements: Must possess a Degree in Pharmacy, Chemical Sciences or equivalent. Having Masters, MBA or PHD would be considered a vital asset. Minimum 8 years\' related experience in Pharma, FMCG, and Healthcare industries. Thorough understanding and demonstrated ability in product development for regulated & semi-regulated markets. Detailed understanding of regulatory guidelines/regulations for successful dossier preparation, and submission of Generic products in US, EU and /or global markets. Sound understanding of pharmacokinetics & biopharmaceutical aspects of product development. Consistent record of delivering formulations by initiating and developing a perfect in-vitro tool to predict the in-vivo behavior of the molecules/formulation under development. Proficient in Microsoft Office Suite. Proficient in using software / tools relevant to the pharmaceutical or healthcare industry etc Scientific rigor, attention to detail / meticulous. Excellent mentoring, coaching and people management skills. Strong intrapreneurial skills and mindset from start up to established organization. Versatile and resilient, ability to stay positive in high-pressure and ambiguous environments and work towards delivering results.

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