Summary:

The purpose of this position is to carry out assigned laboratory duties which may include sampling, testing, and evaluating analytical data on samples such as raw materials, in-process, and final products. In addition, will also develop and validate analytical methods.

Essential Duties & Responsibilities:

The following statements are intended to describe the general nature and level of work being performed by an individual assigned to this job. Other duties may be assigned.

• Perform analytical testing in support of product development and method validation.
• Conduct laboratory tests in compliance with established internal Standard Test Methods (STMs), compendial and vendor/partner supplied methods.
• Maintain organized records of tests performed and results obtained by following company policies.
• Perform basic troubleshooting and preventative maintenance of laboratory equipment.
• Understand and comply with all company policies, safety procedures, and SOPS, including cGMPs and cGLPs.
• Assist in the preparation analytical data for internal and external meetings and presentations.
• Assist in performing laboratory investigations. Contribute to written investigation reports as required.
• Maintain a level of technical knowledge and understanding in the assigned areas of responsibility that are consistent with the current scientific requirements of the company.
• Participate in the transfer of methods to/from the Quality Control department.

Interaction:

• The incumbent works closely with all functional areas in Research and Development, Manufacturing, Quality Assurance, Quality Control, Document Control and Regulatory Affairs.

Skills:

Knowledge, Skills, and Abilities:

• Basic understanding of the chemical and physical principals upon which formulation, process development and analytical methodology is based.
• Familiarity with concept of cGMPs.
• Basic skills in using typical laboratory and processing equipment (e.g. HPLC, UV Spec, pH meter, centrifuge, etc.).
• Ability to utilize scientific information resources within the assigned area of responsibility.
• Good observation skill, problem solving, and troubleshooting skills (e.g. rational progression of investigation).
• Good understanding of the scientific thinking in the design of experimental protocols.
• Basic documentation skills (e.g. notebook, reports) with attention to detail and legible handwriting.
• Good organizational skills (e.g. daily tasks, documentation, archived information).
• Good interpersonal skills (e.g. working with members of other teams to achieve shared goals).
• Good verbal and written English communication skills (e.g. able to participate in scientific discussions and written interactions).
• Proficient in the use of computers and widely used workplace applications (e.g. Microsoft Office, Outlook, graphing software, etc.).
• Ability to be flexible in adapting work plan to current corporate goals.
• Basic time management skills (e.g. multi-tasking and task prioritization).

Education:

• Bachelor’s degree in relevant field of study (e.g. chemistry, pharmacy, biology, engineering, etc.) from an accredited college or university required.
• 1 year combined academic and pharmaceutical industry experience.