Chief Scientific Officer - Pharma

• Develop pharmaceutical products for highly regulated markets including the US and EU the ROW and domestic markets.
• Capabilities include multifinished dosage forms (FDFs) (tab/cap/solution/suspension/gel/emulsion/etc.) for various routes of administration (oral/injectable/inhalation).
• Comprises a highly qualified scientific team with the expertise to cater to the goals in adherence to respective territorial regulations.

• Develop robust analytical test methods for quality control ranging from cleaning of equipment to batch release through stability program for the RMs as well as FDFs including inhouse APIs.
• Contributes to troubleshooting analytical issues at R&D AVL and plant (OOS etc.)
• Highly expert scientific team handling an array of instruments including highend ones viz. ICPMS LCMS GCMS etc.

• Develop APIs of several categories catering to different markets (regulated/semiregulated/etc.)
• Vertically integrated with the formulation development team as per customerspecific requirements for products that require the companys API source.
• Aims to reduce the RMC to secure the markets.

• Involved in product lifecycle management correspondences with regulatory agencies setting of specifications response to deficiencies submissions (ANDA/PAS/CBE) review/approval of documents etc.
• Involvement in postapproval management activities (annual report supplements etc.)
• Coordinates with CQC/QA during FDA inspections.

• Performs an extensive search for the existence of patents in different geographies including trademarks.
• Generation of patent landscape reports for FRD.
• Suggesting portfolio team on blocking patents and earliest market entry thereby aiding in building a portfolio for the Company and selection of products for development.

• Specializes in creating new molecules/entities for specific indications and conducting preclinical trials for CT (with the help of the clinical team).
• Aim at novel molecules with a target of becoming innovators globally

• Lead the deliveries set against the goals through aggressive tracking mechanisms/followups.
• Sets project charter organizes stage gates reviews meetings; and ensures timely escalation and immediate resolution of conflicts.
• Establish short and longterm project goals and design strategies to achieve them.

• Conceptualize design plan and execute Bioavailability/Bioequivalence Studies with Pharmacokinetic Pharmacodynamics and Clinical or In vitro endpoints by global regulatory requirements and GxP compliance.
• Ensure availability of qualified contract service providers study protocols and validated bioanalytical methods for human and animal PK/TK studies with simple to complex study Designs.

• More than 20 years of experience in the Pharmaceutical industry and at least 10 years of experience in leadership roles managing both Formulation and Analytical departments in any of the top Pharma companies.
• Qualified Ph.D. (Pharmaceutics / Pharmaceutical Technology)
• Work proactively with other crossfunctional teams in R&D Manufacturing and Head Office to resolve projectrelated issues and lead to the successful completion of timelines.
• Highly skilled in the evaluation and interpretation of data and drawing conclusions.
• Able to design innovative strategies & achieve goals within defined timelines
• Ability to multitask and prioritize responsibilities.
• Decisionmaking and analytical thinking skills.
• Excellent written and verbal communication skills in English
• Excellent reporting skills.
• Good Mentor and Motivator.
• Strong project management and technical structure skills

api development,api,formulation research,bioequivalence studies,analytical research,bioavailability studies,intellectual property rights,chemical formulation,formulation,pharmaceutical product development,clinical research,chemical research,regulatory affairs,research and development (r&d),new drug discovery,project management,research & development