Job Description
The purpose of this role is to provide analytical chemistry support to Phlow. This is an exciting opportunity for individuals with analytical chemistry experience to develop and perform analytical experiments under the direction of the Director, Analytical Chemistry, or other team members. The candidate will support Phlow's contract development and manufacturing services to ensure business objectives are met for execution of the internal Phlow API development as well as commercial projects. The candidate will personify Phlow's shared values and culture, both internally and externally. The candidate will work with the highest standards of safety, integrity, transparency, and ethics to create win-win scenarios for patients, customers, partners, and colleagues. While not required, we appreciate you accompanying your application with 1-3 professional references if you are able to provide.
Requirements
Essential Job Duties & Responsibilities • Independently conduct analytical method development, validation, and project support
• Work closely with QC department
• Identify technical challenges during analytical method development and perform analytical method troubleshooting
• Manage CMO/CRO analytical project resources as required such as contractors and contract laboratories, as needed
• Manage technical direction of analytical projects; identify key deliverables and next steps and communicate to the team
• Responsible for data review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.
• Identify and implement new techniques and instrumentation to expand internal capabilities
• Author and review technical reports, regulatory submissions, SOPs, validation protocols, and other cGMP documents
• Performs the assigned analytical tasks with minimum supervision in support of product development and clinical trial material.
• Performs activities within the assigned timelines and in compliance with cGXP's, regulatory requirements, and company practices and procedures
• Responsible for the design and conduct of studies in accordance with company and regulatory standards to facilitate new product development
• Manage day-to-day laboratory activities for analytical equipment, including sourcing consumables, troubleshooting, maintaining equipment and calibrations with various vendors
Experience & Qualifications • Advanced degree in chemistry, pharmaceutics, or related field.
• 15+ years experience in analytical method development, validation and API and/or drug product development activities regulated by FDA
• Working knowledge of standard Office tools (MS Office, MS Project, Excel, Visio, SharePoint).
• Ability to work well both independently and with a team.
• Broad range of functional expertise in analytical chemistry, compound purification, spectral analysis/interpretation.
• Experience with common analytical techniques such as: HPLC, LC/MS, GC, GC/MS, KF, LOD, DSC, TGA, NMR, UV, LC-MS, Raman, FTIR
• Excellent written and verbal communication skills
• Strong interpersonal skills
Preferred Qualifications • Ph.D. with a minimum 10 years of experience, M.S with a minimum 15 years of experience, or B.S. degree with a minimum 20 years of experience in Analytical Chemistry, Pharmaceutical Sciences, or a related scientific field
• Knowledge of ICH and cGMP requirements
• Experience working for a contract organization (CROs/CMOs/CDMOs) is a plus
• Experience with technical and operational risk assessments (e.g., process robustness, mutagenic impurities, nitrosamines, etc.) is a plus
• Experience with the development and implementation of Process Analytical Technology (PAT) is a plus
• Experience with Design of Experiments (DOE) is a plus
Physical Requirements • Constantly required to see to utilize computer screens and monitors to perform job duties including reading & writing, as well as when presenting information and communicating with others.
• Frequently required to talk or hear to communicate with employees, candidates, vendors, and others, including presenting information in front of groups.
• Frequently required to reach with arms and hands performing repetitive motions and using finger dexterity to work primarily at a computer keyboard and with a mouse.
• Frequently required to sit, and occasionally required to stand or walk to move around primarily in an office environment.
• Occasionally lift and/or move up to 10 pounds.
• This position may require up to 5% travel with occasional increase in travel demands based on business needs.
Job Tags
Full time, Contract work, For contractors,