HomeProductionManager/Sr. Manager - Analytical Development | Alivira Animal Health | Ambernath, Thane

Manager/Sr. Manager – Analytical Development | Alivira Animal Health | Ambernath, Thane

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Alivira Animal Health is a USD 150mn integrated global animal health company operating in the area of animal health API and formulations with a strong presence across EU, Latin America, Turkey, Africa, India, and CIS, offering products across the feed, nutritional & therapeutic segments covering food-producing and companion animal species.

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Our vision is to be the best-in-class, integrated platform from APIs to Formulations in the hugely attractive global Animal Health market. Alvira is a subsidiary of Sequent Scientific Limited, a listed company operating in areas of Animal Health, Human Health, and Analytical Services, employing more than 1,600 people globally. (www.alivira.co)

Designation: Manager/Sr. Manager – Analytical Development

Location: Ambernath, Thane, Maharashtra, India

Job Description:

Roles and Responsibilities

  • Lead and Responsible for all Analytical development Function
  • Candidate must know and have practiced ICH and Regulatory guidelines/requirements of the USA and EU.
  • Expertise in Analytical techniques that cater from early stage to late stage of product development.
  • Experience in Analytical Method Development, Analytical Method Validation and Analytical Method Transfer -Assay, Related substances, and Dissolution for the finished products (Orals Solids -Tablets & Powders, – Liquids Solution & Suspension and Injectable Formulations) as per regulatory requirements.
  • To ensure method Development and method validation as per the project and regulatory requirements.
  • Lead the method/technology transfer from R&D to manufacturing locations operating Globally.
  • Review and approval of Standard operating procedures (SOPs), Analytical test instructions, Analytical method validation protocols, and reports, Analytical method transfer protocols, and reports.

  • Review of standard test procedures and specifications for raw materials.
  • Review of Lab Note Books, Method development reports, stability data.
  • Review of documents from API manufacturers.
  • The literature search for new product analytical method development.
  • Preparation of Analytical strategy, planning of activities, and execution the same within the timelines.
  • Ability to provide a strategic direction to the Analytical team with necessary technical leadership.
  • To ensure the Team members are following Good Laboratory Practices and Good documentation practices.
  • Identify and develop third-party service providers for outsourced work/specialized testing/methods
  • Ability to work with internal and external customers.
  • Co-ordinating with cross-functional departments like FD, DQA/QA, PM, Quality control Engineering, Purchase for routine day to day activities to resolve the issue with proper time management.
  • To conduct training sessions for team members on the advances in Analytical development and regulatory updates.

Desired Candidate Profile

  • 10 years plus Experience in Validation and Development of Analytical methods for dosage forms like liquids, solids, and Injectable.
  • Experience as an analytical team lead in generic drug product development for regulated. Markets both the EU and the USA.
  • Experience in leading and handling a team size of 10+ scientists.
  • Effective Communication and presentation skills.
  • Strong ability to troubleshoot issues or challenges during analytical method development, Method Validation, and Method transfer, etc.
  • Knowledge on Microbiology for Pharmaceutical dosage forms is added advantage

Qualification: M Sc ,M. Pharm or PhD

Experience: 10-20 Years

Salary: Negotiable

Contact Details:

Swapnil Sarvankar

swapnil.sarvankar@sequent.in

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