Clinical and Scientific Specialist
4 weeks ago
Clinical and Scientific Specialist
Job Summary:The Clinical and Scientific Specialist will be responsible for executing SOPs and protocols for large batch preparation of formulations and intermediate solutions. This role includes the completion of batch paperwork and the use of computer software packages, such as MS Office, for the collection and reporting of batch preparation. The Specialist will work closely with the research and development team to ensure the efficient and effective execution of laboratory operations.
Key Responsibilities:- Perform daily functions in batch preparation of formulations and intermediate solutions.
- Review and complete manufacturing batch records.
- Provide basic maintenance to GxP equipment.
- Complete all necessary inventories and documentation for batch preparation.
- Assist with chemical inventory for materials.
- Complete all documentation following the preparation of the batches throughout the process.
- Communicate effectively with the research, development, and pilot teams.
- Assist with additional projects assigned by cross-functional teams.
- Working knowledge in MS Office Suite, including Word and Excel.
- Detail-oriented with excellent hand-eye coordination.
- Working knowledge of cGMP requirements.
- Effective teamwork and communication skills.
- Ability to meet strict deadlines and work under pressure.
- Flexibility in accepting work assignments as required by the needs of the business.
- Working with a large amount of chemicals.
- The individual will be required to work in a laboratory environment.
- The role will require the individual to come into contact with hazardous materials or working environments. The individual will be required to wear/use the appropriate personal protective equipment (PPE) for the task in hand outlined in SOP's including items such as lab coat, eye protection and gloves. The job requires the handling of materials that come under COSHH guidelines.
- 2 years of cGMP experience is required.
- 2-4 years of laboratory experience.
- Medical Device or related regulatory industry experience is preferred.
- High School Diploma/GED is required.
- Associate's or Bachelor's degree in Science discipline is encouraged.
Mindlance is an Equal Opportunity Employer and does not discriminate in employment on the basis of - Minority/Gender/Disability/Religion/LGBTQI/Age/Veterans.
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