Adare Pharma Solutions
Overview
Join to apply for the
Senior Analytical Scientist
role at
Adare Pharma Solutions . Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Adare works closely with pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients. Each role and department within Adare offers a customized experience with a chance to make a real impact. Adare is transforming lives by transforming drug delivery! Join our mission at
Adare ! What Adare Can Offer
Medical/dental/vision/life – low employee premiums 401k with a highly competitive match Generous PTO, including floating holidays Career growth and internal opportunities Tuition reimbursement Relocation assistance Performance-based bonus Employee Recognition Programs Responsibilities
Develop and validate pharmaceutical analytical methods for potency, dissolution (ex-tended-release formulations experience preferred), impurities/degradation products, and residual solvents using instruments such as HPLC, UHPLC, LC-MS, Dissolution Apparatus, GC. Author methods, procedures, and documents in support of projects and regulatory filings, including CTD format CMC sections for ANDAs and NDAs. Train and mentor less experienced scientists and QC analysts. Provide testing support for formulation development and clinical supplies. Transfer methods internally (QC) and externally. Lead Analytical Project Teams; coordinate activities to achieve project goals, represent the R&D Analytical Sciences group in meetings with customers and internal groups, and make decisions to move the project forward. Keep management up to date on progress and issues during project execution. Complete other duties as assigned. Required Skills And Qualifications
PhD with a minimum of 6 years of relevant pharmaceutical laboratory experience or MS with a minimum of 10 years or BS with a minimum of 12 years of relevant pharmaceutical laboratory experience. Excellent interpersonal written and oral communication skills. Proficient in Microsoft Office. Ability to coordinate, contribute to and work within a cross-functional team. Able to prioritize duties and lead multiple projects from start to finish with minimal supervision. Attention to detail and strong organizational skills. In-depth knowledge of pharmaceutical operations, GMP, lab procedures and equipment, ANDA/NDA/DMF/IND documents and safety procedures. Physical Requirements
Stand, walk, push, pull, twist, reach overhead, and bend to the floor. May be required to wear PPE during certain operations; exposure to chemicals, noise, dust, mists, and fumes. Occasionally move items or equipment. Occasionally climb ladders or steps to reach equipment. Read precision measuring equipment, machine dials, gauges, and thermometers; observe fine details using a microscope. Must have sense of smell to detect odors of unacceptable compounds or mixtures. Must have steady hands and good physical coordination to handle laboratory instrumentation and equipment. Equal Opportunity
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES
#J-18808-Ljbffr
Join to apply for the
Senior Analytical Scientist
role at
Adare Pharma Solutions . Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Adare works closely with pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients. Each role and department within Adare offers a customized experience with a chance to make a real impact. Adare is transforming lives by transforming drug delivery! Join our mission at
Adare ! What Adare Can Offer
Medical/dental/vision/life – low employee premiums 401k with a highly competitive match Generous PTO, including floating holidays Career growth and internal opportunities Tuition reimbursement Relocation assistance Performance-based bonus Employee Recognition Programs Responsibilities
Develop and validate pharmaceutical analytical methods for potency, dissolution (ex-tended-release formulations experience preferred), impurities/degradation products, and residual solvents using instruments such as HPLC, UHPLC, LC-MS, Dissolution Apparatus, GC. Author methods, procedures, and documents in support of projects and regulatory filings, including CTD format CMC sections for ANDAs and NDAs. Train and mentor less experienced scientists and QC analysts. Provide testing support for formulation development and clinical supplies. Transfer methods internally (QC) and externally. Lead Analytical Project Teams; coordinate activities to achieve project goals, represent the R&D Analytical Sciences group in meetings with customers and internal groups, and make decisions to move the project forward. Keep management up to date on progress and issues during project execution. Complete other duties as assigned. Required Skills And Qualifications
PhD with a minimum of 6 years of relevant pharmaceutical laboratory experience or MS with a minimum of 10 years or BS with a minimum of 12 years of relevant pharmaceutical laboratory experience. Excellent interpersonal written and oral communication skills. Proficient in Microsoft Office. Ability to coordinate, contribute to and work within a cross-functional team. Able to prioritize duties and lead multiple projects from start to finish with minimal supervision. Attention to detail and strong organizational skills. In-depth knowledge of pharmaceutical operations, GMP, lab procedures and equipment, ANDA/NDA/DMF/IND documents and safety procedures. Physical Requirements
Stand, walk, push, pull, twist, reach overhead, and bend to the floor. May be required to wear PPE during certain operations; exposure to chemicals, noise, dust, mists, and fumes. Occasionally move items or equipment. Occasionally climb ladders or steps to reach equipment. Read precision measuring equipment, machine dials, gauges, and thermometers; observe fine details using a microscope. Must have sense of smell to detect odors of unacceptable compounds or mixtures. Must have steady hands and good physical coordination to handle laboratory instrumentation and equipment. Equal Opportunity
Adare Pharma is an equal opportunity employer & prohibits unlawful discrimination based on race, color, religion, gender, sexual orientation, gender identity/expression, national origin/ancestry, age, disability, marital & veteran status. PRINCIPALS ONLY NO AGENCIES OR THIRD PARTIES
#J-18808-Ljbffr