Description:

　　Position: R&D Chemist II

　　Duties/Responsibilities:

　　Provide analytical support to a designated range of products enabling revenue growth, increased laboratory capability, and enhanced lab quality compliance.

　　Ensure all feasibility work, analysis, validation, stability, industry trials, and development are performed on time, meeting QbD standards and meet all regulatory requirements.

　　Analytical support for all KPIs for the laboratory and operations.

　　Analytical support scale up activities for all projects to commercial scale.

　　Analytical development, optimization and scale up of all dosage forms.

　　Create and review technical documents including analytical method development reports, method development/validation protocols and reports, standard operating procedures in compliance with regulatory requirements.

　　Perform bench work such as HPLC, GC and dissolution.

　　Salary Range : $67k-$73k (depends on experience)

　　Qualifications:

　　Must Have

　　Education and Experience:

　　Bachelor’s degree in relevant science field with minimum 1-3 years’ experience.

　　A minimum 1-3 years’ experience in a cGMP or cGLP laboratory environment required.

　　Knowledge of analytical techniques including HPLC. (GC, FTIR and dissolution experience a plus)

　　Experience using chromatographic software (Empower 3 – strongly preferred).

　　Excellent analytical, technical writing, communication and data management skills to present data to internal technical and project teams & potentially to clients.

　　Proven scientific and technical ability to design and execute experimental studies as well as statistically analyze data, author and review protocols and reports.

　　Must be able to think critically and troubleshoot typical analytical (HPLC) instrumentation problems.

　　Knowledge & experience with cGMP, cGLP, USP and the regulatory requirements for pharmaceuticals.

　　Highly motivated and self-driven individual with ability to work independently, and multi-task, adhere to aggressive timelines in support of department and company objectives

　　Preferred

　　2-3 years’ experience in the FDA drug/pharmaceutical industry

　　Demonstrated in-depth scientific knowledge & experience in analytical method development, & validation

　　Experience in the development of pharmaceutical dosage forms and polymeric drug delivery systems with emphasis in transdermal

　　Experience in statistical data analysis and QbD principles

　　An understanding of polymer science, analytical development, drug and formulation characterization, optimization and scale-up

　　Benefits:

　　401(k)

　　401(k) matching

　　Dental insurance

　　Flexible spending account

　　Health insurance

　　Life insurance

　　Paid time off

　　Tuition reimbursement

　　Vision insurance

　　Interview Process:

　　30-minute Teams interview with hiring manager

　　If the hiring manager likes them, then a 1.5-2-hour onsite interview will be scheduled with them and the team.

　　About Aerotek:

　　We know that a company's success starts with its employees. We also know that an individual's success starts with the right career opportunity. As a Best of Staffing® Client and Talent leader, Aerotek's people-focused approach yields competitive advantage for our clients and rewarding careers for our contract employees. Since 1983, Aerotek has grown to become a leader in recruiting and staffing services. With more than 250 non-franchised offices, Aerotek's 8,000 internal employees serve more than 300,000 contract employees and 18,000 clients every year. Aerotek is an Allegis Group company, the global leader in talent solutions. Learn more at Aerotek.com.

　　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.