5 - 10 years
4 - 9 Lacs
Posted:2 months ago|
Platform:
Work from Office
Full Time
Job Title: Biology Lead - Drug Discovery Scientist Location: Hyderabad, India Company: Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) About the Company: Morepen Proprietary Drug Research Pvt. Ltd. (MPDRPL) is a cutting-edge pharmaceutical R&D company focused on the development of New Chemical Entities (NCEs) and Novel Drug Delivery Systems (NDDS). MPDRPL is located in Hyderabad, India. MPDRPL is driven by innovation, with a focus on meeting unmet medical needs across various therapeutic areas. Job Description: MPDRPL is seeking an experienced and motivated Biology Lead Drug Discovery to join R&D team. This full-time, on-site role in Hyderabad is central to advancing NCEs through invitro and invivo, preclinical biology studies. The role will involve guiding a biology team and overseeing the development of assays, conducting binding assays, and playing an essential role in drug discovery.As the Biology Lead, you will guide the team through various stages of drug development, manage collaborations, ensure quality control over outsourced work, and contribute to critical decisions for NCE advancement. Key Responsibilities: Assay Development: Lead the development and optimization of biochemical, cell-based, cytotoxicity, and ex-vivo assays to evaluate drug candidates for efficacy, safety and ADMET across multiple therapeutic areas. Biomarker Identification & Validation: Oversee the identification and validation of biomarkers for each drug target, supporting the development of NCEs. Leadership Skills: Build and retain a high-performing Biology team to drive the execution of various invitro and invivo biology studies necessary for NCE development. Collaboration with External Partners: Establish and manage collaborations with academic institutes, biotech companies, and contract research organizations (CROs) to conduct in-vitro and in-vivo studies. Preclinical Study Review: Review pharmacokinetics (PK), efficacy studies in animal models (rat, mouse, dogs), and establish in-vitro/in-vivo and PK/PD correlations to support decision-making in NCE development. Emerging Trends and Drug Target Proposals: Monitor emerging trends in drug discovery and propose novel drug targets for internal NCE development, helping to portfolio. Project Planning and Budgeting: Lead the planning, budgeting, and CAPEX for NCE development projects and internal infrastructure requirements. Regulatory Filings and Reporting: Prepare and oversee reports for various biology studies, ensuring that modules are ready for regulatory filings (IND, NDA) and meet compliance standards. Preclinical Study Management: Act as the Single Point of Contact (SPOC) for all in-vitro and in-vivo preclinical studies related to NCE development. Deliverables: Successful development and optimization of assays across various therapeutic areas. Identification and validation of biomarkers for each drug target. Timely and high-quality outsourced preclinical results. Regular reporting and documentation for regulatory filings. Independent analysis and propose Go/No-go decisions based on preclinical data. Successful management of project budgets, CAPEX, and timelines. Build strong and capable Biology team with high retention and growth. Qualifications: Academic Qualification: PhD (preferred) or Master's degree in Biology, Pharmacology, or a related field. Experience: Minimum of 8+ years of experience in drug discovery and development with a focus on preclinical biology. Strong experience in developing biochemical, cell-based, cytotoxicity, and ex-vivo assays. Proven expertise in biomarker identification and validation for drug targets. Good experience in managing outsourced research, including working with CROs, academic partners, and biotech companies. Knowledge of IND enabling studies, GLP and Non-GLP studies, Preclinical ADMET, pharmacokinetics (PK), efficacy studies, and establishing PK/PD correlations. Experience in preparing regulatory filings and reports for drug development studies. Technical Skills: Expertise in the development and optimization of various preclinical assay platforms (biochemical, cell-based, cytotoxicity, ex-vivo). Familiarity with AI/ML applications in pharmaceutical R&D is a plus. Strong knowledge of drug discovery processes, including in-vitro and in-vivo studies. Proficiency in project management, budgeting, and CAPEX planning for R&D projects. Strong understanding of animal models, PK/PD studies, and their relevance to drug development. Experience in preparing documentation and reports for regulatory filings (IND, NDA). Soft Skills: Exceptional leadership and team-building skills. Strong analytical, problem-solving, and decision-making abilities. Excellent communication skills, both written and verbal. Ability to collaborate effectively across multidisciplinary teams and external partners.
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