Aerotek Analytical Chemist III in Bedford, Massachusetts
Top Skills: HPLC Method Development/Validation GC/MS
Overview We are seeking a highly motivated Analytical Chemist III to join our Analytical Development team. In this position you will be responsible for developing and qualifying phase-appropriate analytical test methods to support clinical development of our drug product portfolio. This individual will write methods, standard operating procedures, method qualification/validation protocols and reports, as well as engage in trouble-shooting and conducting continuous improvement on existing methods. Additionally, this position is expected to mentor junior colleagues and will likely have a supervisory component.
Responsibilities • Develop analytical test methods in support of project requirements • Participate in/supervise HPLC/UPLC, GC, and other analytical method development and validations • Transfer validated methods to Quality Control • Help maintain and troubleshoot analytical instruments • Communicate results and observations to the management team • Serve as a member of CMC/Project teams as the analytical development representative • Mentor and/or supervise laboratory chemists • Provide expert interpretation of data and compare results to established specifications or anticipated trends • Think creatively, problem solve, and develop innovative solutions based on sound scientific analysis • Author SOPs, development reports, study protocols, and validation reports • Liaise with contract laboratories performing method development or testing for Ocular Therapeutix • Mentor junior team members
hplc, method, development, validation, gc, ms, uplc, gmp, capa, change control
Top Skills Details:
HPLC Method Development/Validation GC/MS
Additional Skills & Qualifications:
Qualifications • BS or higher degree in Chemistry or Analytical Chemistry, Master’s preferred • 5+ years of progressively more demanding analytical experience and hands-on experience within the pharmaceutical or biotechnology industry • Hands on knowledge of Instrumental analysis techniques, including, HPLC/UPLC, GC, FT-IR, KF. Other techniques (particle size measurements, NMR, GPC, LC-MS, viscometry) are a plus • Experience working in a cGMP environment • Familiarity with USP and ICH guidelines and incorporation of these requirements into method development and validation • Work as part of a team, assisting colleagues in providing a functional, safe working environment while maximizing laboratory efficiency • Ability to execute controlled experiments with a strong attention to detail • Driven self-starter with capability to either work independently, as a part of a team, or as a mentor • Comfortable working in a fast paced, high pressure environment • Proficient computer skills including Empower and statistical analysis software
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.
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