Posting ID: JP-002665936
• Develop and validate analytical methods in support of R&D product development.
• Develop and validate analytical cleaning methods in support of Cleaning Validation/Verification.
• Provide leadership for proactive analytical technical support of R&D product development.
• Readily identify and assimilate widely divergent technologies and apply the unanticipated outcome to address advanced technical issues/needs.
• Perform relevant physical characterization of pharmaceutical products by development of discriminating dissolution methods.
• Perform RLD evaluation, including reverse engineering principles.
• Perform chemical physical tests on R&D projects including raw material, in-process material, finished ose products and stability.
• Perform API characterization and raw material testing, including chemical and physical tests utilizing both Vendor methods, USP/NF monographs, and novel methods as needed.
• Troubleshoot analytical instrumentation.
• Perform validation Investigations and Deviations.
• Identify current and projected technical and instrumental needs and provide capital budgeting proposals to align laboratory capabilities accordingly.
• Provide expert review on OOS or aberrant investigation and develop action plans to meet sound scientific practices.
• Write experimental protocols, summary reports, analytical methods, SOPs.
• Maintain appropriate documentation (records and lab notebook) for all processes, observations and results as per SOPs and test methods.
• Learn new techniques and solve complex analytical problems.
• Perform training and technical mentoring for team members.
• Provide expert review of technical issues and OOS investigations and develop appropriate action plans to deliver innovative solutions and definitive root cause analysis.
• Provide continual benchmarking of methodology and technology platforms to make recommendations for resource allocation, cost savings and increased efficiencies.
• Interact effectively with multi cross-functional teams and work closely with other departments for preparation of regulatory filings.
• Comply with lab SOPs, GLP, GMP, and company safety requirements.
• Perform other related duties as assigned to meet departmental and company objectives.
• Thorough understanding of and ability to apply QbD, SOP, GMP, GLP, ICH and compendia guidelines.
• Familiar with current regulatory requirements for drug product manufacturing and ANDA submissions.
• Ability to make literature searches and review raw material technical packets and correlate data to existing internal projects
Skills & Qualifications:
Chemistry, pharmaceutical industry, wet chemistry, method validation, Analysis, rfa, sop, glp, QbD, ICH, hplc
Bachelor’s or Master’s degree in science
Actalent connects passion with purpose. Our scalable talent solutions and services capabilities drive value and results and provide the expertise to help our customers achieve more. Every day, our experts around the globe are making an impact. We’re supporting critical initiatives in engineering and sciences that advance how companies serve the world. Actalent promotes consultant care and engagement through experiences that enable continuous development. Our people are the difference. Actalent is an operating company of Allegis Group, the global leader in talent solutions.
The company is an equal opportunity employer and will consider all applications without regards to race, sex, age, color, religion, national origin, veteran status, disability, sexual orientation, gender identity, genetic information or any characteristic protected by law.
Recruiter: Jean Chambers
Phone: (410) 579-3072