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Senior Scientist, Biopharmaceutics print Print

Company Name: Dr Reddys Labs
Location: Hyderabad
Experience: 8 - 10 year(s)
Annual Salary: INR 2500000 - 2500000
Disability Accepted: Hearing Impairments (Hard of Hearing), Hearing Impairments (Total Deafness), Hearing and Speach Impairments, Intellectual Disabilities, Learning Disabilities, Locomotor Impairments, Mental Illness, Speech Impairments, Visual Impairments (Low Vision), Visual Impairments (Total Vision Loss), Developmental Disabilities
Vacancies: 1
Posted by : Fanny Mercy , 328 days ago

Job Description

Industry: Pharmaceuticals
Functional Area: Pharmaceuticals
Job Role : Senior Scientist, Biopharmaceutics
Job Description: Biopharmaceutics inputs in Product selection [US/EU/EMIN]
Bio complexity assessment (probability of success: on a high, medium, low scale) based on literature review and past experience of products
IN ORDER TO provide inputs on bio-complexity and risks to select the right products for development
Biopharmaceutics Strategy Support [US/EU/EMIN]
Preparation & review of DSNs to provide relevant inputs from the Biopharmaceutics and PK perspective based on thorough literature review in terms of feasibility and Bio-complexities for new product development, gap analysis etc.
IN ORDER TO ensure selection of right product and accurate identification of related risks
Product Evaluation from Biopharmaceutics perspective [US/EU/EMIN]
Suggesting appropriate Biopharmaceutic strategies, identification of bio relevant/bio discriminatory media/appropriate invitro tools based on CMAs & CQAs, providing inputs and way forward ideas during technical discussions & MRMs, co-ordinating with CFTs, providing specific bio pharmaceutics inputs to Product Development Teams (PDT) for initial & subsequent bio studies, maintenance of Biopharmaceutics functional trackers
IN ORDER TO have invitro equivalent product which would translate into successful BE outcome.
Modelling & Simulation Support
"Strategically design & guide the team in modelling and simulation (using different software's and other Data Analytical tools) of available data
IN ORDER TO maximise biosuccess and identify any potential risks.
Pilot & Pivotal Bio Study Clearance
Assessment of risks from the understanding of CQAs/CMAs & invitro data available for different strategies based on which giving clearance for pilot bio studies/EB manufacturing through BAT meetings & phase gates, for pivotal studies through bio council meetings
IN ORDER TO achieve successful outcome within in product timeline/milestones
People Management
Management of reportees w r t priorities and to align the same with the organizational priorities w r t technical requirement, Helping team members to solve the issues with CFTs w r t data requirement, technical up gradation & helping in setting up the goals/plan
IN ORDER to meet the organizational goals, motivate people and develop technical expertise within Biopharmaceutics
Addressing regulatory queries [US/EU/EMIN]
Addressing regulatory queries and preparation and reviewing of Deficiency responses, guiding the PDT to generate additional data to address the Regulatory queries
IN ORDER TO ensure successful approval of product within stipulated timelines

Desired Candidate Profile

Key Skills: knowledge of formulation design and performance (invitro & in vivo) understanding including differentiated and innovative products in order to design the strategic path to make the product bio success, Exposure to PK-PD Modelling & Simulation (M&S), Understanding of Preclinical and clinical PK and IVIVC/PBPK and Mathematical Compartmental Modelling.
Qualification: M.Pharm, PhD
Candidate Profile: MPharm / PhD in Bio-pharmaceutics and pharmacokinetics or Pharmaceutics / pharmacology

Deep: Formulation design and development understanding.
Anticipated (theoretical & hypothetical) strategic pathway for the product performance. Invitro tools available, simplest pathways to achieve the invitro equivalence. Guiding the team to provide technical inputs on time.
IVIVC, strategically inputs for modelling and simulation. identification of bio relevant media and evaluation of bio results and finding the way forward w r t formulation design and study design.
Knowledge on analytical development, clinical pharmacology, preclinical, regulatory understanding of regulated markets like US, EU and Russia, China, India etc. Regulatory requirements for biowaiver submission, waiving of pilot studies and SUPAC understanding for leveraging products

Must be good at People management, CFT interaction, Hypothetical & logical thinking on the performance of the product, Communication skills

Company Profile

Company: Dr Reddys Labs
Company Description: Refer company website

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