Job Description

Description:

We need an experienced HPLC analyst to help others in the lab so look for a Bachelors with at least 5 year of HPLC experience or a Masters with at least 3 years of HPLC experience.

Department/Function: Pharmaceuticals R&D New Product Development/Stability

Summary:

This position is responsible for analytical testing, validation/verification, and/or transfer of test method supporting Pharmaceuticals parenteral products. Work will primarily support stability testing, but may also support new product development and/or sustaining product initiatives.

The individual in this position must:

• Develop design strategies and research projects, which are non-routine with areas of expertise and address specific technical requirements of a project.
• Studies, designs and recommendation reflect by and to related disciplines
• Displays a solid understanding of theories/practices utilized by other disciplines outside the primary area of expertise
• The individual must not be allergic to Penicillin, Cephalosporin, or their related products and/or materials.

Essential Duties and Responsibilities:

• Conduct critical chemical, physical, and biological analyses on finished product stability samples. May also support testing of raw materials, initial, in-process, and final product samples from manufacturing facilities or department projects. Work under minimum supervision.
• May act as a study director for studies, supervisor for testing exceptions and owner for laboratory investigation. Independently evaluate results and impact to studies/laboratory.
• May provide training and supervision to junior members within the laboratory. Routinely provide advice and assistance to team members regarding unique problems.
• Perform review of test data, which includes overall documentation practices. Perform review functions in LIMS or other computerized systems.
• Use sophisticated laboratory instrumentation and computer systems to collect and record data. May be required to be a system owner or conduct validations.
• Perform advanced biological and chemical assays requiring precise analytical skills and understanding of chemistry principles. Complete all testing, including special project / protocol testing in a timely and appropriate manner to meet project schedules
• Maintain data integrity and ensure compliance with company SOPs and specifications, FDA, cGxP, and QSR regulations.
• Collaborate with other functions/departments to solve problems, increase efficiency, improve quality and provide product support.
• Maintain laboratory safety requirements, perform equipment maintenance/calibration, and troubleshoot instrumentation

Qualifications:

• Must have good oral and written communication skills, strong analytical skills and be detail oriented.
• Proficient in advanced wet chemistry, volumetric preparation techniques and instrumental methods of analysis
• Must demonstrate effectiveness in ability to train others, leadership, organization, teamwork/interpersonal skills, results orientation, and task completion
• Must be able to handle multiple tasks concurrently and in a timely fashion
• Possess relevant laboratory/technical, writing, and computer skills.
• Ability to organize and communicate complex information effectively with managers, peers, and subordinates.
• Utilize a logical, methodical approach in independently solving problems, developing solutions, and making recommendations that are scientifically justified and meet quality requirements.
• Ability to effectively mentor junior level associates
• Ability to make decisions when provided with limited information and to make routine decisions independently.
• Ability to design experiments and draw meaningful conclusions from lab data.

Physical Activities and Requirements:

• Must be able to hand write and use computers for the majority of the work day
• Must be able to transfer materials, mix solutions/product(s), open products, and perform laboratory testing
• May require standing for extended periods
• Must be able to lift up to 10 pounds routinely

Skills:

FDA, GMP, USP, HPLC, GC, Lab, chemistry, LIMS

Additional Skills & Qualifications:

HPLC Experience

GC experience

Experience Level:

Intermediate Level

About Actalent:

Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We\'re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.

The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.

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