Role Summary: Reporting to the R&D Manager, this role is responsible for 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:

• Develop analytical methods for the testing pharmaceutical ingredients and finished product for products that are developed in house or site transferred into this facility.
• Participate in the development of protocols and final reports and perform validation of analytical methods in accordance with current FDA guidelines. Participate in the transfer of validated methods to QC.
• Verify compendial methods for USP ingredients at first use. Review USP for changes to current methods and specifications. Assure that these changes are tested and implemented as required.
• Source any needed equipment and materials for the methods.
• Work with R&D Product Development on reformulation of pioneer products.
• Work with R&D Product Development on testing new formulations.
• Perform analysis for process and cleaning validation campaigns with the assistance of the Quality Control
• Test samples for stability/pilot lots and for the on-going stability program.
• Operate, troubleshoot and maintain analytical equipment used in laboratories, such as: HPLC, GC, AA, FTIR, dissolution apparatus and TOC analyzer.
• Interface with FDA compliance officers during facility inspections as needed.
• Accurately document all data in compliance with GMP.
• Communicate with 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

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.

Competencies required for the role:

• ANALYTICAL THINKING/PROBLEM SOLVING - is the ability to identify the information needed to clarify a situation, seek that information from various sources and then tackle a problem by using a logical, systematic, sequential approach. Ability to identify and separate the key components of problems and situations. Ability to interpret information from a range of sources to spot patterns and trends in information and to deduce cause and effect from this
• CREATIVITY AND INNOVATION - is the ability to create, develop and implement a new product, process, or service with the aim of improving efficiency, effectiveness, or competitive advantage. Also, the ability to transcend traditional ideas, rules, patterns, relationships, or the like, and to create meaningful new ideas, forms, methods, or interpretations.
• ADAPTABILITY/CHANGE AGILITY – Is the ability to be agile and adapt to constant change; shows good resistance to pressure and stress; is resilient and open-minded. The ability to demonstrate support for innovation and for organizational changes needed to improve the organization’s effectiveness, initiating, sponsoring, and implementing organizational change. The ability to change in order to fit or work better on some situation or purpose and embraces change. Strives for continuous improvement.
• RESULTS ORIENTED – The ability to focus on the desired result of one’s own department’s work, setting challenging goals, focusing on the goals, and meeting or exceeding them.
• TEAMWORK - Able to collaborate within a team to achieve a common goal or initiative.

REQUIREMENTS

Essential:

• 1 - 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
• Strong written and verbal communication skills
• Strong math and computer skills are required

Desirable:

• Master’s Degree
• Experience in analytical development of HPLC methods

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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More Info at www.bimedacareers.com

Job Type: Full-time

Pay: From $65,000.00 per year

Benefits:

• 401(k)
• 401(k) matching
• Dental insurance
• Employee assistance program
• Employee discount
• Flexible spending account
• Health insurance
• Health savings account
• Life insurance
• Paid time off
• Parental leave
• Professional development assistance
• Relocation assistance
• Retirement plan
• Tuition reimbursement
• Vision insurance

Schedule:

• Monday to Friday

Ability to commute/relocate:

• Le Sueur, MN 56058: Reliably commute or willing to relocate with an employer-provided relocation package (Preferred)

Education:

• Bachelor's (Required)

Experience:

• analytical laboratory: 1 year (Required)

Work Location: Hybrid remote in Le Sueur, MN 56058

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