Company : Actalent
Country: United States
Location : Baltimore, Maryland
Post: Sun, 19 Sep 2021 05:06:58 GMT
Expires: Tue, 19 Oct 2021 23:59:59 GMT
Apply Job : Apply Online
—————————— Job Description ——————————
DESCRIPTION:The Analytical Chemist will play a key role in the development of products and the advancement of critical R&D programs. He/she will work in the R&D Laboratory in Baltimore, MD, and be responsible for developing and validating analytical methods for small-molecule APIs and formulations, transferring established methods to CROs/CMOs, and establishing GMP-compliant lab systems and procedures. Responsibilities also include collaborating with R&D team members to determine appropriate testing and specifications for lead compounds and formulations as well as providing analytical support and testing of ingredients, candidate compounds, and formulations for research, development, clinical, and commercial stages. Other duties of the job include working closely and collaboratively with business partners, consultants, company employees, external vendors, and suppliers to provide guidance and support for R&D, regulatory, and commercial analytical activities.The ideal candidate thrives in a fast-paced, innovation-driven environment, and is flexible, pro-active, resourceful and collaborative with a high degree of personal accountability and professionalism. Your responsibilities will include: Perform analytical method development and validation activities, including the development and implementation of new methods and enhancement of existing methods. Work collaboratively with company employees, business partners, API/raw material suppliers, contract labs, and CMOs to develop, validate, transfer, perform, and troubleshoot analytical methods to support product development and commercialization. Lead aberrant data investigations for both internal and contract labs. Support a cleaning validation program by writing protocols/reports and validating analytical methods. Establish, review, and maintain documentation (methods, specification, protocols/reports, SOPs, etc.) and other quality requirements for a development and commercial pharmaceutical laboratory. Perform, document, and troubleshoot routine analyses in support of research, development and commercial testing including incoming materials, in-process, product, cleaning/process validation, and stability. Review and interpret data for technical content and regulatory compliance. Document all laboratory testing and maintain accurate and legible records Perform equipment installation, qualification, maintenance, calibration, and troubleshooting. Perform general laboratory practices including but not limited to lab housekeeping, supply ordering/receipt, sampling, contract lab shipments, and waste disposal. Write relevant sections of IND, NDA, and other regulatory submissions. Provide scientific/technical guidance, auditing, and training related to analytical and quality system activities. Maintain proper training and understanding of company SOPs and GMPs. Maintain safe work practices. Manage time effectively and multiple projects simultaneously. Perform other duties and projects as assigned.SKILLS:Chemistry, HPLC, R&D, Research, product development, method validation, GPC, uv vis, analytical chemistry, chemical engineering, pharmacology, nano-particles, drug delivery, perform research, materials science, process development, formulation, Computer Validation, Instrument Qualification, validation verification, AuditingTOP SKILLS DETAILS:Chemistry,HPLC,R&D,Research,product development,method validationADDITIONAL SKILLS & QUALIFICATIONS:Experience: Ph.D., M.S., or B.S in chemistry, biochemistry, pharmacology or related field A minimum of 5 years of industry experience in pharmaceutical analytical development. Extensive knowledge and hands-on experience in analytical quantitation and characterization, particularly HPLC, LC-MS, GC, NMR, FTIR, UV, dissolution, KF, and wet chemical analysis for small-molecule compounds. Familiarity with USP, ICH, and FDA regulations and guidance. Experienced in designing and conducting appropriate method development and validation studies to support product development and regulatory submissions. Experience with injection, implant, ophthalmic or modified-release products.Skills and values: Ability to deliver results in dynamic, fast-paced, multi-tasking, milestone-driven, rapidly changing research and GMP environments. Possesses a high degree of personal responsibility, accountability, and professionalism. Strong verbal and written communication skills, teamwork, and interpersonal skills. Enjoys working collaboratively in a team environment with scientists and staff of different backgrounds and experience levels. Ability to prioritize and re-prioritize activities as needed to accomplish unanticipated requests or initiate new projects requiring immediate attention. Good planning, organization, and execution skills. Curious, resilient and takes pride in delivering quality results. Self-starter who sets clear priorities, takes accountability and works well in teams. Acts with integrity based on high ethical standards. Thrives on diversity of opinions and embraces open and honest conversations.EXPERIENCE LEVEL:Expert Level ABOUT ACTALENT: 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. Were 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.
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