Analytical Chemist III

Sharp Clinical Services; Bethlehem (Northampton County); On-site; USD 85,000 - 110,000; Full time

Job summary

Sharp Clinical Services seeks an Analytical Chemist III to independently perform routine and non-routine analyses on drugs and materials using instrumental and wet chemistry techniques.

The role includes leading projects, developing methods, authoring reports, and mentoring junior staff within a cGMP-regulated laboratory environment. Collaboration with cross-functional teams and adherence to SOPs are essential.

Qualifications

• BS or BA in Chemistry with 5+ years analytical drug development experience.
• MS in Chemistry with 2+ years analytical drug development experience.
• PhD in Chemistry with at least 1 year analytical drug development experience.

Responsibilities

• Perform routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using various instrumental and wet chemistry techniques.
• Independently design and execute method development and validation activities for pharmaceutical drug product development.
• Author protocols and reports as needed.
• Serve as a dedicated project leader and SME for analytical testing requirements for drug development and regulatory submissions.
• Mentor and guide junior chemists and participate in client project meetings.

Skills

HPLC analysis

Dissolution testing

Moisture determination

Analytical drug development

Project leadership

Documentation & cGMP

Oral and written communication

Education

Bachelor's in Chemistry

Master's in Chemistry

PhD in Chemistry

Tools

HPLC instrumentation

Dissolution apparatus

Moisture analyzers

Job description

SummaryThe Analytical Chemist III independently performs routine and non-routine analysis on raw materials, drug substances, reference materials and drug products using a variety of instrumental and wet chemistry techniques. The Analytical Chemist III will also intermittently serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions. In addition, the Analytical Chemist III maintains the laboratory and all documentation within cGMP guidelines.Essential Duties and ResponsibilitiesØ Perform routine and non-routine analysis on raw materials, drug substances, reference material and drug products using a variety of instrumental and wet chemistry techniques.Ø Independently design and execute method development and validation activities for pharmaceutical drug product development on a limited basis.Ø Author protocols and reports as needed.Ø Serve as a dedicated project leader and subject matter expert for analytical testing requirements for drug development and regulatory submissions on a limited basis.Ø Mentor and guide junior chemists on a limited basis.Ø Attend client project meetings related to analytical testing timelines on a moderate basis.Ø Conduct laboratory testing in accordance with methods, protocols, SOPs and cGMP guidelines.Ø Assist in maintaining an organized laboratory.Ø Preparing and reviewing documentation such as laboratory notebooks, validation and analysis reports, SOPs, methods and monographs.Ø Develop systems that are cost effective and increase efficiency.Ø Interface with all departments as necessary.Ø Adhere to set safety standards.Ø Participate as a team member, support the company mission, and vision and contribute to the pursuit of the company's goals.Ø Participate actively in regular meetings.Ø Achieve expected performance measures.Ø Other duties as assigned.QualificationsTo perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required.Ø BS or BA degree in Chemistry or a related physical science with 5+ years of analytical drug development in a pharmaceutical laboratory preferred.Ø Master’s degree in Chemistry or a related physical science with 2 years of analytical drug development in a pharmaceutical laboratory preferred.Ø PhD in Chemistry or a related physical science with at least of 1 experience in analytical drug development in a pharmaceutical laboratory preferred.Ø Experience in HPLC analysis, dissolution, andmoisture determination techniques strongly preferred.Ø Excellent oral and written communication skill to communicate with the team, peers, management, and external contacts.Ø Experience with interpreting and implementing cGMPs, ICH, FDA, DEA and OSHA guidelines.Ø Must have the ability to work effectively and independently.Ø Working knowledge of personal computers and Microsoft Office Products, including Word, Project, and Excel