Analytical Chemist II

Sterling Pharma Solutions Limited; Town of Germantown (WI); On-site; USD 65,000 - 90,000; Full time

Job summary

Sterling Pharma Solutions Limited is seeking an Analytical Chemist II to perform routine and non-routine analytical testing in support of API development and manufacturing.

The role focuses on HPLC/GC based methods, wet chemistry, and data interpretation, with opportunity to contribute to method development and validation in a fast-paced environment.

Qualifications

• Bachelor’s degree in chemistry with 3+ years lab experience.
• Master’s degree with 2+ years relevant lab experience.
• Experience with analytical instrumentation theory and practice.
• Ability to troubleshoot equipment and interpret data.

Responsibilities

• Performs routine analytical testing of materials and products.
• Coordinates testing for water, gases and environmental monitoring.
• Sets up instrumentation per written methods with minimal supervision.
• Demonstrates proficiency with HPLC, GC, LC-MS, IC, DSC, TGA, KF, FTIR and ICP-OES.
• Trains and mentors less experienced chemists and ensures compliance.

Skills

HPLC

GC

LC-MS

FTIR

ICP-OES

DSC

TGA

KF

Mentoring

Education

Bachelor’s Degree in Chemistry

Master’s Degree in Chemistry

Tools

LC-MS instrumentation

GMP/QA software

Job description

Analytical Chemist II

Summary of role

The Analytical Chemist II is accountable for driving results in a fast-paced environment by performing analytical routine and non-routine testing in support of active pharmaceutical ingredients development or pharmaceutical manufacturing. This position may also be required to work on method development/method validation projects. Typical types of testing: assays (potencies, related substances, residual solvents, metals etc.), moisture content, identification, and various other wet chemistry based measurements. HPLC and/or GC based methodologies are commonly employed in the described testing, while other key methodologies applied include: titrations, UV, DSC, TGA, IR. Test methods employed may be compendial (i.e. USP, EP) or proprietary (client supplied or developed by Sterling). This person must have the ability to efficiently organize the routine work with minimum supervision and to properly evaluate and interpret generated data is required. The Analytical Chemist II must have a detailed understanding of the theoretical basis of the methods/experiments along with ability to troubleshoot equipment is also required. Works on problems of moderate scope in which analysis of situation or data requires a review of identifiable factors. Exercises judgment within defined procedures and practices to determine appropriate action. The position requires superior leadership behaviors of the Sterling core competencies and non-negotiables, as well as expertise in functional competencies included in this position profile.

This position works a Monday - Friday Day Shift

Essential Functions

• Performs routine analytical testing of pharmaceutical raw materials, in-process samples, finished products and stability samples using established test methods and procedures.
• Performs and coordinates testing for RO/DI water, compressed gas, and other environmental monitoring testing.
• Coordinates and facilitates shipment of samples to outside vendors for testing.
• Sets up various instrumentation for testing according to written test methods with little to no supervision.
• Demonstrates proficiency with HPLC, GC, LC-MS, IC, DSC, TGA, KF, FTIR and ICP-OES.
• Plans and executes analytical testing with minimal supervision.
• Performs analyses in a timely and efficient manner.
• Trains and mentors less experienced chemists.
• Ensures training records and binder are up to date and in compliance.
• Shows initiative and interest in learning new techniques and tests.
• Participates in technical discussions and brainstorming sessions.
• Identifies and troubleshoots analytical problems with instrumentation, general chemistry, test methodology and samples submitted.
• Communicates issues or challenges to senior staff and/or management.
• Reviews test data acquired by others and witness’s others notebooks.
• Writes technical documentation such as OOS/atypical investigations, deviations and CAPAs.
• Ensures timely completion and compliance with cGMP and all other relevant company training requirements.
• An individual in this position must be able to successfully perform the essential duties and responsibilities listed above. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions of this position.

Key competencies

• Experienced with various analytical instrumentation theory and practice.
• Ability to read, analyze and interpret general business periodicals, professional journals technical procedures and governmental regulations.
• Ability to write reports, business correspondence and procedure manuals.
• Ability to effectively present information and respond to questions from groups of managers, clients, customers and the general public.
• Ability to perform complex math functions, compute ratios, rates, and percentages.
• Ability to draw and interpret graphs and charts.
• Ability to solve practical problems and deal with a variety of concrete variables in situations where limited standardization exists.
• Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form.
• Performs assigned tasks carefully and on schedule according to standard operating procedure and supervisor instructions.
• Demonstrates company loyalty in relations with company personnel.
• Maintains a safe, clean and organized work environment free of safety hazards.
• No direct reports, but accountable for leading and influencing others.
• Participates in the hiring process of other employees.
• Schedules and/or reviews the work of other employees.
• Coaches, mentors and develops other employees.
• Applies job skills and company policies and SOPs to complete a broad range of difficult tasks.
• Receives minimal instruction on day-to-day work, general instructions on new assignments.
• Candidates need to be competent with IT systems, and Microsoft Office including Outlook, PowerPoint, Word and Excel.
• Please note this job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee for this job.
• Duties, responsibilities and activities may change at any time with or without notice.

Education and Experience

• Bachelor’s Degree in Chemistry (or related field) with minimum 3 years of relevant laboratory experience; or
• Master’s Degree in Chemistry (or related field) with minimum 2 years of relevant laboratory experience.

Travel Requirement

• Up to 5% travel required.

Diversity and Inclusion:

Sterling values diversity and we are committed to creating an inclusive environment for all employees. All employment decisions are based on business needs, job requirements and individual qualifications, without regard to race, color, religion, sex, pregnancy, age, national origin, physical or mental disability, past or present military service, marital status, gender identification or expression, medical condition (including genetic characteristics) or any other protected characteristic as established by law.