Senior Analytical Associate II

Senior Analytical Associate II Kellyu00ae Science & Clinical is seeking Senior Analytical Associate II for a Direct Hire position with a Biopharma CDMO client at their site in Harleysville PA. If youu2019re passionate about bringing the latest scientific discoveries to life and are ready to take the next step in your career, trust The Experts at Hiring Experts. Compensation: $95,000-$105,000/yr Schedule: Monday-Friday, 1 st shift Location : Harleysville, PA Duration: Direct Hire Summary: We are seeking a highly experienced Senior Analytical Associate II to join our Laboratory CDMO team. This role is crucial for supporting our manufacturing campaigns and requires an expert blend of 8-15+ years of pharmaceutical industry experience, especially in small molecule method development and validation. The position maintains a roughly 50/50 split between hands-on analytical bench work (primarily HPLC/UPLC) and leading complex technical writing and documentation efforts (SOPs, protocols, and reports) under strict cGxP guidelines. Responsibilities: + Execute and lead analytical method development and validation activities, critically focused on small molecule methods, utilizing HPLC/UPLC instrumentation. + Provide high-level oversight and coordination of analytical testing to ensure all materials are tested to current specifications in support of upcoming manufacturing campaigns. + Perform extensive technical writing activities, including the generation of validation protocols, Standard Operating Procedures (SOPs), technical reports, and drug product/excipient monograph revisions. + Coordinate laboratory testing activities both internally and externally, including managing sample shipment and receipt within the analytical laboratory. + Ensure all laboratory work and documentation strictly adhere to cGxP (GMP, GLP, GDP) principles. + Represent the analytical laboratory in client meetings as needed to discuss technical findings and documentation status. + Work effectively within a core analytical team of four colleagues. Qualifications: + College degree in chemistry or a related scientific discipline. + 8-15+ years of experience in the pharmaceutical industry, with a focus on solid and liquid dosage forms. + Minimum 4+ years of experience in analytical method development and/or validation, specifically for small molecules. + Expert, hands-on experience operating and troubleshooting HPLC/UPLC instrumentation. + Extensive experience with and strong working knowledge of cGxP principles. + Proven experience with technical writing activities associated with method validations, SOPs, protocols, and technical reports. + Fluent English language skills (both written and spoken). Preferred Experience & Attributes + Direct experience utilizing Empower software. + Experience with dissolution apparatus 1 and/or 2. + Minimum 5 years of experience in a cGMP laboratory. + Highly organized, detail-focused, with strong problem-solving and risk mitigation skills. + Client services approach and mindset (internal and external). + P#1Send Resumes to As part of our promise to talent, Kelly supports those who work with us through a variety of benefits, perks, and work-related resources. Kelly offers eligible employees voluntary benefit plans including medical, dental, vision, telemedicine, term life, whole life, accident insurance, critical illness, a legal plan, and short-term disability. As a Kelly employee, you will have access to a retirement savings plan, service bonus and holiday pay plans (earn up to eight paid holidays per benefit year), and a transit spending account. In addition, employees are entitled to earn paid sick leave under the applicable state or local plan. Click here ( for more information on benefits and perks that may be available to you as a member of the Kelly Talent Community. Why Kelly u00ae Science & Clinical? Kelly Science & Clinical is your connection to premier scientific and clinical companies looking to hire industry experts just like you. Our team creates expert talent solutions to solve the worldu2019s most critical challenges. Every day, we match science professionals with dream jobs that fit their skills, interests, and career goalsu2014itu2019s the way we think job searching should be. Nearly 100 percent of our science recruiters have a professional background and education in science, so we know a thing or two about the science market and how to get your expertise noticed. About Kelly Work changes everything. And at Kelly, weu2019re obsessed with where it can take you. To us, itu2019s about more than simply accepting your next job opportunity. Itu2019s the fuel that powers every next step of your life. Itu2019s the ripple effect that changes and improves everything for your family, your community, and the world. Which is why, here at Kelly, we are dedicated to providing you with limitless opportunities to enrich your lifeu2014just ask the 300,000 people we employ each year. Kelly is committed to providing equal employment opportunities to all qualified employees and applicants regardless of race, color, sex, sexual orientation, gender identity, religion, national origin, disability, veteran status, age, marital status, pregnancy, genetic information, or any other legally protected status, and we take affirmative action to recruit, employ, and advance qualified individuals with disabilities and protected veterans in the workforce. Requests for accommodation related to our application process can be directed to the Kelly Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment. Kelly participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S.Kelly Services is proud to be an Equal Employment Opportunity and Affirmative Action employer. We welcome, value, and embrace diversity at all levels and are committed to building a team that is inclusive of a variety of backgrounds, communities, perspectives, and abilities. At Kelly, we believe that the more inclusive we are, the better services we can provide. Requests for accommodation related to our application process can be directed to Kellyu2019s Human Resource Knowledge Center. Kelly complies with the requirements of Californiau2019s state and local Fair Chance laws. A conviction does not automatically bar individuals from employment.

Created: 2025-12-05