Adare Pharma Solutions
Vandalia, Vandalia, Ohio, United States of America
Job Description
Posted Thursday, July 17, 2025 at 10:00 AM Adare Pharmaceuticals Inc. Analytical Scientist II (Vandalia, OH) Provides support for the development and validation of pharmaceutical analytical methods such as potency, dissolution, impurities/degradation products, and residual solvents using appropriate laboratory instrumentation, including HPLC, UHPLC, LC-MS, Dissolution Apparatus, and GC. Supports formulation development activities by testing development samples, clinical samples, and stability samples. Develops and evaluates analytical test methods for raw materials, in-process products, and finished products. Conducts and documents chemical and physical testing of finished products, raw materials, active pharmaceutical ingredients, and stability samples to support new product formulation development for both ANDA and NDA projects. Performs method verification and method validation in accordance with approved method validation protocols, company standard operating procedures (SOPs), FDA Guidance, and ICH Guidelines. Conducts and documents in-process and finished product testing for product release and stability as per the approved test methods. Attends SOP, safety, and scientific trainings to remain current with cGMP regulations and safety standards. Authors experimental protocols, reports summarizing experiment findings, and revisions of testing methods and SOPs. Oversees equipment calibrations and repairs from internal or external partners, coordinating timing and expectations. Troubleshoots equipment and testing methods while optimizing and developing new testing approaches. Conducts peer data review and mentors new employees on instruments and test methods. Performs complex testing, such as multistage dissolution. Attends client meetings and manages client interactions. Requirements: Bachelor’s degree in chemistry, pharmaceutical sciences, or related field, and five years of experience in a pharmaceutical laboratory. Alternatively, master’s degree in chemistry, pharmaceutical sciences, or related field, and two years of experience in a pharmaceutical laboratory. Proficiency with cGMP, ICH, and FDA compliance. Experience in small molecular chemical synthesis, API manufacturing and process development of generic meeting FDA guidance, and pharmaceutical manufacturing per cGMP procedures. Experience in analytical method development/validation such as HPLC, UPLC, GC, TGA, DSC, Ultraviolet-visible (UV), Spectrophotometer, FTIR, or NMR under GMP environment. Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there’s no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can’t quickly verify the identity of the poster. Vandalia, Vandalia, Ohio, United States of America
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Posted Thursday, July 17, 2025 at 10:00 AM Adare Pharmaceuticals Inc. Analytical Scientist II (Vandalia, OH) Provides support for the development and validation of pharmaceutical analytical methods such as potency, dissolution, impurities/degradation products, and residual solvents using appropriate laboratory instrumentation, including HPLC, UHPLC, LC-MS, Dissolution Apparatus, and GC. Supports formulation development activities by testing development samples, clinical samples, and stability samples. Develops and evaluates analytical test methods for raw materials, in-process products, and finished products. Conducts and documents chemical and physical testing of finished products, raw materials, active pharmaceutical ingredients, and stability samples to support new product formulation development for both ANDA and NDA projects. Performs method verification and method validation in accordance with approved method validation protocols, company standard operating procedures (SOPs), FDA Guidance, and ICH Guidelines. Conducts and documents in-process and finished product testing for product release and stability as per the approved test methods. Attends SOP, safety, and scientific trainings to remain current with cGMP regulations and safety standards. Authors experimental protocols, reports summarizing experiment findings, and revisions of testing methods and SOPs. Oversees equipment calibrations and repairs from internal or external partners, coordinating timing and expectations. Troubleshoots equipment and testing methods while optimizing and developing new testing approaches. Conducts peer data review and mentors new employees on instruments and test methods. Performs complex testing, such as multistage dissolution. Attends client meetings and manages client interactions. Requirements: Bachelor’s degree in chemistry, pharmaceutical sciences, or related field, and five years of experience in a pharmaceutical laboratory. Alternatively, master’s degree in chemistry, pharmaceutical sciences, or related field, and two years of experience in a pharmaceutical laboratory. Proficiency with cGMP, ICH, and FDA compliance. Experience in small molecular chemical synthesis, API manufacturing and process development of generic meeting FDA guidance, and pharmaceutical manufacturing per cGMP procedures. Experience in analytical method development/validation such as HPLC, UPLC, GC, TGA, DSC, Ultraviolet-visible (UV), Spectrophotometer, FTIR, or NMR under GMP environment. Attention Job Seekers and Applicants: Please be aware of attempted recruiting scams. While Adare does conduct virtual interviews for some positions, we do NOT use Skype or Google Meet. If you are contacted by someone regarding a job opportunity, please be vigilant in reviewing the details of any and all correspondence. Here are some things to look out for: bad grammar; font inconsistencies or formatting irregularity: logos not properly sized, stretched out, blurred; numerous different font styles and sizes within the content of an email or letter; company impersonators (postings that mirror a reputable company, but there’s no link to the business) mismatched email or website domains, or there is difficulty with locating an address, business phone number, and/or email address, financial requests: Do not provide payment or account credentials as part of the application process. Legitimate companies should not require transfers, checks, gift cards or the wiring of funds as a condition of the application process. Additionally, equipment purchases: be cautious if a company asks you to purchase your own equipment (computers, iPads, mobile phones) and requests you to mail it to their IT department. Applicant Follow-up Questions: Proceed with caution if you receive an application follow-up request that requires you to click on a link to answer additional questions; especially if the questions request personal information such as a social security number. General anonymity: proceed with caution if you can’t quickly verify the identity of the poster. Vandalia, Vandalia, Ohio, United States of America
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