DifGen Pharmaceuticals

Senior Research Associate

DifGen Pharmaceuticals  •  ₹500k - ₹900k/yr  •  State of Telangāna, IN (Onsite)  •  11 days ago
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Job Description

Job Location: Prashanti Nagar IE Kukatpally Hyderabad, TELANGANA 500072,

Position Type: Full Time,

Salary Range: ₹500,000.00 - ₹900,000.00 Salary/year,

Job Shift: Day,

  • Enhancing, devising, and implementing technically stable and successful formulations of finished products to meet the company requirements for ANDA (US), EU, Market for semi-solid dosage form
  • Improvising formulations, Formulation optimization, Process optimization using QbD approach (US market).
  • Efficiently worked at various Third-party locations for manufacturing for newly developed product as well as location transfer of existing products. Coordinating activities, preparation of technical documents, material arrangement (procurement or transfer), manufacturing, analysis, launch of product.
  • Taking stringent measures including preparation of necessary technical documents to ensure compliance with quality standards and customer requirements. Generating, reviewing and approving technical documents like MFR, MPR, BMR, BPR, Trade dress, Product Development Report (PDR), Stability study protocol, Hold time study protocol, in- use study protocol, Alcohol dose dumping study protocol, Bill of Material (BOM) and relevant SOPs; implementing filing systems in relation to materials used for development of product.
  • Performing patent search, evaluation, and literature review on formulation projects, conducting, and interpreting the stability studies as per the ICH guidelines.

Qualifications: Education: B.pharm, M.Pharm or equivalent

Experience: 5-8 Years in Formulation Documentation (R&D) with USFDA, EU, MHRA, ANVISA requirement

Technical Skills: Expertise in preparing and reviewing regulatory documents and reports, Strong understanding of data management and documentation tools, Proficiency in formulation design and development

Soft Skills: Excellent written and verbal communication skills, Problem-solving mindset and proactive approach to challenges, Ability to work independently and as part of a team, Strong attention to detail and organizational skills

DifGen Pharmaceuticals

About DifGen Pharmaceuticals

We are a US based Global Pharmaceutical company with a primary focus on developing complex high barrier to entry Generics and Specialty Pharmaceutical products that would help increase accessibility to high quality medication thereby leading to the creation of next generation healthy communities. We are driven by an earnest pursuit of redefining the accepted standards in pharmaceutical product development and commercialization. We consistently aspire to challenge standard thought processes to arrive at dependable solutions that create a paradigm shift in product development, quality, clinical affairs, regulatory sciences, and commercial strategy. Our talented team with some of the brightest minds have developed a holistic understanding of the nuances associated with the development of unique, commercially viable and difficult product lines across varying therapeutic areas and a broad array of dosage forms such as Injectables, Ophthalmics, Topicals, Biologicals, Drug Devices, Soft Gels, Solid Orals & Suspensions.

Industry
Chemicals & Materials
Company Size
51-200 employees
Headquarters
Hyderabad, IN
Year Founded
Unknown
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