Scientist/Senior Scientist - AR&D Job at Perrigo
Perrigo Company is dedicated to making lives better by bringing Quality, Affordable Self-care products that consumers trust everywhere they are sold. Help us do it.
External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
Description Overview
Provides technical support to assigned projects, using robust scientific methods which comply with standard operating procedures and scientific standards. Works with limited direction. As appropriate, may serve as a project leader to manage analytical support for projects with minimal supervision.
Scope of the Role
- Perform physical and chemical testing on raw material, in-process, finished product and stability samples. This incudes documentation review.
- Develop, validate and transfer analytical methods of varying complexity in compliance with both internal and external customer standards.
- Provide multiple options to successfully resolve complex analytical problems and deviation investigations that significantly impact project timelines. Uses a high level of scientific judgement based on prior work experience to perform tasks. Accurately maintain all related documentation in compliance with SOPs.
- Prepare documents for regulatory filings (ANDA, NDA, ANDS). Design experiments, provide data and provide responses to comments on FDA deficiency letters.
- Attend and present data at project-related meetings, interact with cross functional teams and external testing laboratories to ensure proper completion of analytical aspects of projects.
- Research, prepare and review technical documents, including but not limited to SOPs, drug master files, technical packages, vendor qualification, raw material and release and stability specifications, stability summaries, test methods, and certificates of analysis which conform to company standards.
- Conduct technical document review for external departments. Approve analytical reports, CofA, specifications, test methods and deviations related to own or other projects. Provide technical and procedural training and mentoring for junior team members.
Experience Required
- Demonstrated ability to develop and perform critical reviews of a wide variety of technical and scientific documents, including but not limited to drug master files, certificates of analysis, qualification and technical packages for conformance to country-specific scientific documentation requirements, such as USP, FDA submissions or European Pharmacopeia.
- Demonstrated ability to develop and validate complex analytical test methods which are robust and reliable, using a variety of analytical techniques and instrumentation, including but not limited to HPLC, GC, LC/MS, dissolution, UV-Vis and FTIR. Excellent communication skills are essential to work effectively in interdisciplinary teams and investigate and resolve technical problems or deviations.
- A thorough working knowledge of cGMP, cGLP, other US FDA regulations, and ICH guidance documents is essential.
- These skills are normally acquired through completion of a bachelor degree in Chemistry or Pharmaceutical Sciences combined with 6+ years of relevant professional experience, or completion of a master degree in Chemistry or Pharmaceutical Sciences combined with 3 to 5 years of professional experience, or completion of a doctoral degree in the same fields combined with 0 to 2 years of relevant professional experience.
External applicants please note: To apply to this position please click the APPLY button at the bottom of the application. (The SAVE button will only save your profile information but not submit an application for this open position.) Thank you.
We are seeking a diverse applicant pool to ensure the diversity of our team reflects the end consumers we serve through our self-care mission. We are proud to be an equal opportunity employer that celebrates our team’s differences. Individuals of all races, ethnicities, nationalities, ancestries, religious creeds, sexual orientations, genders, gender identities and gender expressions, national origins, ages, mental and physical abilities, familial status,’ veterans status’, military status’ and more are encouraged to apply. TOGETHER, we make lives better. #DIV
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