What are the responsibilities and job description for the Senior Analytical Chemist position at Phlow Corp?

Description

The purpose of this role is to provide analytical chemistry support to Phlow. This is an exciting opportunity for graduates or 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
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 production, review, analysis, and interpretation from a variety of sources. Provide accurate summaries and make recommendations to stakeholders with scientific rigor.
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.

5 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

Excellent written and verbal communication skills

Strong interpersonal skills

Preferred Qualifications

Ph.D. with a minimum 2 years of experience, M.S with a minimum 5 years of experience, or B.S. degree with a minimum 10 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.

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