Senior Analytical Scientist

Adare Pharmaceuticals

  • Vandalia, OH
  • Permanent
  • Full-time
  • 16 hours ago
Are you ready to join a growing, global drug development and manufacturing organization that puts people first? Come to Adare! We work closely with our pharmaceutical industry partners during all phases of drug development with a mission of improving the lives of patients and medicines essential to people all over the world. Each role and every department within Adare offer you a unique, customized experience with a chance to make a real impact, and is critical to our success. With the help of people like you dedicated to our mission, Adare is transforming lives by transforming drug delivery!Join our mission at Adare!What can Adare offer you?
  • 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
We are seeking to hire a Senior Analytical Scientist to join our Analytical Sciences team…If any of the below describes you, we would love to meet you!JOB SUMMARYThe essential job functions are to (1) perform the development and validation of analytical methods for raw materials, work-in-process, and finished products, including preparation of development and validation documents and (2) to lead analytical teams, prioritizing workflow and activities and providing testing support for the formulation development and clinical supplies release testing and stability programs. Also, to provide training, coaching, and mentoring for more junior scientists, including assisting with planning and execution of Analytical Research Projects.RESPONSIBILITIES AND LEARNING OPPORTUNITIES
  • Develop and validate pharmaceutical analytical methods for potency, dissolution (ex-tended-release formulations experience preferred), impurities/degradation products, residual solvents using appropriate laboratory instrumentation e.g. HPLC, UHPLC, LC-MS, Dissolution Apparatus, GC.
  • Author methods, procedures, and documents in support of projects and regulatory filings, including CTD format CMC section for ANDA’s and NDA’s.
  • 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; including coordinating activities designed to achieve project goals in an efficient manner, represent the R&D Analytical Sciences group in team meetings with customers and internal groups, and make decisions for the project team to move the project forward.
  • Keeps Management up to date on all progress and issues that arise during project execution
  • Completes other duties as assigned
REQUIRED SKILLS AND QUALIFICATIONS
  • PhD with minimum of 6 years of relevant pharmaceutical laboratory experience or M.S. with a minimum of 10 years of relevant pharmaceutical laboratory experience or a B.S Degree 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 organizational skills.
  • In-depth knowledge of pharmaceutical operations, including GMP, lab procedures and equipment, ANDA/NDA/DMF/IND documents and safety procedures.
PHYSICAL REQUIREMENTS:The employee is required to:
  • stand, walk, push, pull, twist, reach overhead, and bend to the floor
  • The employee may be required to wear personal protective equipment (PPE) during certain phases of the operation; such as high noise areas from machinery, exposure to a variety of chemicals, or exposure to dust, mists, and fumes.
  • occasionally move items or equipment
  • occasionally required to climb ladders and/or steps to reach equipment
  • Requires reading precision measuring equipment, machine dials, gages, and thermometers; must be able to observe fine details utilizing a microscope.
  • Must have sense of smell to detect odors of unacceptable compounds and/or mixtures.
  • Must have steady hands and good physical coordination in order to handle delicate laboratory instrumentation and equipment.
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

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