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R&D Senior Scientist

  Le Sueur, MN,  United States |  Full time

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Posting Date :  2022-10-14

Job Identification :  11095

Department  :  No Category

Role Summary: Reporting to the R&D Manager, this role is responsible for R&D projects, performing analytical services, and report writing to support product development, method development, method validation, and chromatographic impurities testing within cGMP guidelines and company policies/procedures.

Key Role Specific Requirements:

  • Lead product projects from initial product development to drug application submission
  • Develop analytical methods for the testing of pharmaceutical ingredients, finished product, and for products that are developed in house or site transferred into the facility
  • Draft and revise protocols and final reports for validation and verifications of analytical methods in accordance with current FDA guidelines, and support documentation requirements for Regulatory submissions
  • Designs experimental procedures to achieve stated objectives and executes studies based on industry guidance and regulations
  • Perform manufacture verification testing on active pharmaceutical ingredients and excipients
  • Research and review current guidance’s and pharmacopeias to stay up to date on changes in the industry
  • Provides technical input on investigations and/or CAPAs associated with manufacturing and packaging of marketed products
  • Source any needed equipment and materials for the methods
  • Operate, troubleshoot, and maintain analytical equipment used in laboratories, such as: HPLC, GC, FTIR, and Karl Fisher
  • Maintain contact with all company personnel, technical consultants, vendors, service contract personnel, and outside affiliations
  • Accountable for analytical services required to meet or exceed product protection, development, and stability program needs
  • Accurately document all data in compliance with GMP

Please note that this job description is not exhaustive, and the role holder may be required to undertake other relevant duties commensurate with the grading of the post. Activities may be subject to amendment over time as the role develops and/or priorities and requirements evolve.

REQUIREMENTS

Essential:

  • 3+ years of analytical laboratory experience or equivalence is preferred
  • Experience with method development and/or method validation is required
  • Bachelor’s degree in Chemistry is required
  • Analytical thinking and problem solving abilities
  • Creativity and innovation are required
  • Strong written and verbal communication skills
  • Strong math and computer skills are required
  • Adaptability and change agility skills

Desirable:

  • Master’s or PhD Degree
  • 4-7 years of analytical laboratory experience or equivalences is preferred
  • Experience with project management, method development, and method validation

About Bimeda: Bimeda is a leading global innovator, manufacturer and marketer of veterinary pharmaceuticals and animal health products and has over half a century’s experience in providing science-driven solutions to optimize the health, wellbeing and productivity of the world’s animals.

Bimeda’s global innovation program sees six state-of-the art R&D centers across four continents collaborate on an enviable product development pipeline which anticipates the ever-evolving needs of the animal health industry.

Bimeda’s nine manufacturing facilities across seven countries allow the company to manufacture a broad range of preventative, curative and nutritional products including sterile injectables, vaccinations, nutritional boluses, feed additives, tablets, water-soluble powders, pastes and non-sterile liquids.

Globally, the company focuses on the development, manufacture and commercialization of quality Bimeda-branded products while also being the partner of choice for contract manufacturing and R&D services for prominent companies within the animal health industry.

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About Us

Bimeda is a leading global manufacturer,  marketer and distributor of animal health products and veterinary pharmaceuticals.  Through ongoing expansion and strategic acquisition,  Bimeda has established markets in more than seventy countries worldwide and has R&D,  manufacturing and distribution capabilities across Europe,  North America,  South America,  Africa,  Asia and Australasia.


global

OPERATES
IN OVER
80
countries

people

950+
EMPLOYEES

lab

9
R&D
and 7
REGULATORY LABS

factory

11
MANUFACTURING
facilities in
8 COUNTRIES

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