Senior Research Associate/ Asst. Scientist - CMC (Analytical)

Posted 22 Days Ago
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2 Locations
Senior level
Software • Biotech • Pharmaceutical
The Role
The role involves analytical method development, support for formulation development, analytical validation, managing stability studies, and coordinating with vendors for analytical testing. The Senior Research Associate will prepare specifications and reports while ensuring compliance with quality standards, alongside managing procurement and equipment maintenance in the analytical lab.
Summary Generated by Built In

Job Description:

Role: Senior Research Associate / Asst. Scientist

Reporting to: Associate Director – CMC (Analytical)

Location: Hyderabad

Experience: 7 to 10 years of industrial experience in analytical development of formulations. Working experience with complex injectables, hydrogels, large molecules, peptides etc. preferred

Qualification: M. Pharma/M.Sc. in Pharma Chemistry or Equivalent from a reputed University.

Purpose of the Role:

Work as Individual Contributor as part of CMC (Analytical) function and contribute effectively towards timely achievement of CMC & R&D objectives.

Job Description:

  • Carry out analytical method development and pre-validation involved in assigned projects, protocols & reports, in compliance with Ferring QMS to achieve the objectives as per project requirements.

  • Carry out & Ensure Analytical support for formulation development, optimization & scale-up, as applicable to achieve the objectives as per project requirements.

  • Support Analytical method validation and method transfer involved in assigned projects to achieve the objectives as per project requirements.

  • Preparation and updating of Specifications, STPs, analytical protocols and reports for assigned projects to achieve the objectives as per project requirements.

  • Carry out & ensure managing stability study related activities for assigned projects to achieve the objectives as per project requirements.

  • Ensure outside analysis co-ordination for routine & characterization tests and report review for assigned projects to achieve the objectives as per project requirements.

  • Carry out Literature search for analytical & regulatory aspects of assigned project to achieve the objectives as per project requirements.

  • Review of ELN experiments, Data, Reports, and documents generated within lab & those received from CRO/CMO in line with defined quality standards.

  • Support Procurement activities related to project & laboratory i.e. vendor contact, quotes, URS, Coupa etc. in line with defined quality standards.

  • Coordinating with Facility/Vendor for instruments and equipment AM, PM, and regular maintenance in Analytical lab in line with defined quality standard

Required Competencies:

• Sound scientific approach & writing skills

• Good communication skills

• Engagement & accountability towards the defined purpose

• Good team player

Location:Ferring India FHPDC R&D

The Company
HQ: St-Prex
5,940 Employees
On-site Workplace
Year Founded: 1950

What We Do

Ferring Pharmaceuticals is a privately owned, research-driven, specialty biopharmaceutical group committed to building families and helping people live better lives. We are leaders in reproductive medicine and maternal health, and in areas of gastroenterology and urology. We are at the forefront of innovation in microbiome-based therapeutics and uro-oncology intravesical gene therapy. Ferring was founded in 1950 and employs more than 7,000 people worldwide. The company is headquartered in Saint-Prex, Switzerland, and has operating subsidiaries in more than 50 countries which markets its medicines in over 100 countries.

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