Analytical Development Chemist

Position Summary TheAnalytical Development Chemist willdevelop andvalidateanalytical methods, provide analytical support for product development, and design, write, and execute technical documentssuch asprotocols and reports. This role will serve as a subject matter expert for analytical methods and technical writing. Benefits Employee Ownership (ESOP): Company-funded retirement contribution of approximately 18% of pay, plus 401(k) Competitive base salary with performance-based bonus opportunity Comprehensive benefits package: Medical, Dental, Vision, Life, Disability, FSA, and Pet Insurance Generous paid time off, paid holidays, and parental leave Fitness and tuition reimbursement programs Responsibilities Responsible for development and validation of analytical methods (Assay, Impurities, Dissolution, Cleaning, and Residual Solvents). Designs, writes, and executes method validation protocols, reports, and other technical documents in accordance with current industry standards as well as regulatory requirements, i.e. FDA, USP, EP. Coordinate validation projects and ensure all validation documentation is finalized, current and archived as required. Oversee development of analytical services projects including formulations support to stability and validation. Must be able to understand and interpret data from formulation design to in-vitro/in-vivo performance and design experiments to support product development. Must be able to understand the purpose and objective of the studies to appropriately design laboratory experiments and protocols. Coordinates analytical method transfer and training of testing with the Quality Control Laboratory and serves as a technical resource for investigations. All other tasks as requested or assigned. Required Qualifications Bachelor’s or master’s degree in chemistry or related field. PhD preferred. Experience: 3+ years required with advanced degree (research or work experience) work experience with BS degree experience in pharmaceutical analytical method development and validations. Proficient in data analysis including raw data review and interpreting results. Strong writing and documentation skills (cGMP, protocols, reports, OOS investigations, lab notebooks). Proficient with Microsoft Office Suite (Word, Excel, Outlook). Familiar with using QMS systems (i.e., Empower, Master Control). Preferred Qualifications PhD preferred. Experience: prefer 5+ years’ work experience with BS degree experience in pharmaceutical analytical method development and validations. Experience in HPLC, Dissolution, UV-Vis, GC, Cleaning Validations, Empower, and compendial (USP, FCC, EP) testing preferred. Equal Opportunity Employer PBI-Gordon Companies is an Equal Opportunity Employer. We value diversity and are committed to creating an inclusive environment for all employees. Ready to Apply? If you're passionate about pharmaceutical analytical method development and validation, data analysis and technical writing, and working in a cGMP-regulated environment, we'd love to hear from you. Apply today to join an employee-owned company committed to scientific excellence, collaboration, and shared success. We are committed to helping you and your dependents maintain health and wellness by offering voluntary, competitive medical insurance and prescription drug plan options. Choose from two voluntary dental plans that are designed to help protect you and your dependents’ oral health. Our voluntary vision insurance plan is designed to help protect you and your dependents eye health. Coverage is available for eye exams, frames, lenses, and contact lenses. Employee owners are responsible for 100% of the cost of this plan. We offer a company-paid $50,000 life insurance policy with AD&D. You also have the opportunity to purchase additional life and AD&D insurance for yourself, your spouse and/or your dependent children. The cost for this coverage is based on the amount you elect and your age. Our company-paid short-term and long-term disability plans provide income replacement in the event you are not able to work due to illness or injury. Short-term disability will provide 70% income replacement up to $1,350 per week and long-term disability will provide 60% income replacement up to $5,000 per month. EAP Services are company paid to benefit all employee-owners and their families. EAP provides up to six free counseling sessions to help you and your family members manage life stressors, solve personal or relationship concerns, and achieve your goals. Flexible Spending Plans offer employee-owners the option to set aside pre-tax monies into a medical reimbursement or dependent care account to help pay for out-of-pocket medical, dental or vision expenses or day care costs. The maximum contributions are determined by the IRS and adjusted annually. This is a use-it-or-lose-it account; any funds remaining in the account following the close of the plan year will be forfeited. We love our pets! Pet insurance options for your furry friends is offered through the ASPCA. Employee-owners can enroll and pay premiums directly to ASPCA. Paid holidays and paid time off (PTO) include regular PTO, personal PTO, and specified paid company holidays. The amount of PTO depends upon the employee's position and years of service. We act like we own the company because we do! An ESOP provides employees with an ownership stake in the company. It’s an additional form of compensation directly tied to PBI-Gordon Companies financial success. All regular employees are eligible to participate in the ESOP the first of the month following 30 days of service. PBI-Gordon Companies contributes approximately 18% of total compensation annually with a six-year vesting schedule. We offer a 401(k)-retirement savings plan to assist employees with this goal. New employee owners are eligible to participate the first of the month following 30 days of employment. We provide a company match of 100% up to 3% deferral with a three-year vesting schedule. We reimburse up to a maximum of $300 annually for gym/fitness memberships. Children or grandchildren of employee-owners may apply for a scholarship under the William Everett & Mary Ellen Mealman scholarship fund. Applicants are awarded based on financial need, academic achievement, and involvement in extracurricular/community activities. After one full year of employment, employee-owners are eligible for tuition reimbursement for bachelor’s level coursework related to their current job or any future job offered at PBI-Gordon Companies. Company paid parental leave is offered to employee-owners following the birth of a child or the placement of a child with an employee in connection with adoption, foster care, or surrogacy. This policy will run concurrently with Family and Medical Leave Act (FMLA) leave, as applicable. If you are a California resident, you have rights under the California Consumer Privacy Act (CCPA). Employment is contingent upon and may not begin until the successful completion of a pre-employment background check and drug screen. PBI-Gordon and its subsidiaries participate in E-Verify to confirm the identity and employment eligibility of all persons hired to work in the United States. For more information about E-Verify, including your rights and responsibilities, please visit the E-Verify Website. #J-18808-Ljbffr