Pharmaceutical Scientist 2- Analytical Development

Singota Solutions

1d•Onsite

About The Position

The role of the Pharmaceutical Scientist 2 - Analytical Development includes the following key functions carried out in according to the company vision, mission, standards, goals, objectives, and strategic direction: · Actively participates and can lead Development projects for the QC/DEV department including process and analytical development activities. · Collaboratively supports the Quality Control function with respect to raw material, in-process, release, and stability testing. · Mentor Scientists and invested in continuing education. 1. Actively participates and can lead Development Projects for the QC/DEV department including process and analytical development activities. · Operate various lab instruments and equipment as an SME including (but not limited to): Karl Fisher, pH, HPLC, FTIR, UV-VIS, DSC, TOC, Lab-ware washers, Autoclave, Laminar Flow Hoods, Bio-Hazard Hood, Microbalances, and other diverse lab equipment and various wet chemistry techniques. · Lead method transfer activities by authoring, and executing protocols for compendial verifications, experimental testing, and method validation protocols. · Follow written protocols, SOPs, and directions from other lab scientists and manager. · Lead lyophilization development studies using (but not limited to) DSC, FDM, small-scale lyophilization, XRD, and supporting wet chemistry methods. · Follow company documentation SOPs to record and summarize laboratory findings in formal analytical methods reports. · Communicate project status to Sr. Pharmaceutical Scientists, QC/DEV Management, and Project Management personnel. · Monitor usage of laboratory supplies and chemicals, including glassware, equipment, materials, client drug substance/product, and excipients, and assist with material purchases. · General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business. · Technical writing ability to be the lead author on lab reports, SOPs, PM/SC documentation. · Analytical Development client representative for QC/DEV 2. Collaboratively supports the Quality Control function with respect to raw material, in-process, release, and stability testing. · Perform quality control analyses on a variety of equipment following formal written documentation, including SOPs, client methods, and compendial requirements. · Review experimental data, analytical data, and laboratory reports for accuracy. · Record and summarize work conducted and findings according to company documentation SOPs. · Comply with company and laboratory quality and safety management systems including requirements for documentation, training, system use, SOPs, and processes. · Primary analytical liaison between PPD and the laboratory for testing PPD study samples 3. Mentor Scientists and invested in continuing education. · Mentor associate scientists on diverse analytical methods applicable to parenteral product development, including HPLC, Karl Fischer, XRD, CE, UV Vis, and various wet chemistry techniques. · Support in the training of new QC/DEV staff to increase team strength and flexibility. · Promotes a highly professional working environment within the company. · Engage in effective teamwork between operating groups to lead the company towards meeting its goals and objectives.

Requirements

Strong interest and commitment to exceptional customer service and teamwork.
Highly motivated- independent and self-directed work ethic; good judgment and strong decision-making skills; driven to continuously improve.
Excellent interpersonal skills-respected by others with an ability to lead and influence; positive and action-oriented; high degree of personal integrity and accountability; ability to communicate effectively and professionally across various audiences and organizational levels.
Positive attitude and good judgment — reflective of company values.
Technical knowledge base.
Excellent time management, organization skills, and ability to manage multiple priorities with high attention to detail in a fast-paced, deadline driven, work environment.
Excellent communication and presentation skills — oral and written.
Ability to travel to client sites and trade shows.
Ability to problem solve and resolve issues and conflicts.
Excellent skills in MS Word, Excel, Outlook and the ability to effectively learn other computer programs.
Familiarity with and the ability to quickly learn operation of standard laboratory instruments with normal training and access to instrument manuals.
Ability to read computer displays.
Ability to work in both office and laboratory environments requiring sitting and standing.
Manual dexterity and eyesight commensurate with wet chemistry analytical techniques.
Must wear personal protective equipment including protective gloves, lab coats, and safety glasses or face shield at times.
BS in Chemistry / related discipline
Has experience and training in a GMP, GLP, or other regulated organization
Minimum of 5 years of relevant formulation, analytical testing, and/or academic experience
Minimum of 5 years pharmaceutical and/or life science experience preferred, including experience in a contract service organization

Responsibilities

Actively participates and can lead Development projects for the QC/DEV department including process and analytical development activities.
Collaboratively supports the Quality Control function with respect to raw material, in-process, release, and stability testing.
Mentor Scientists and invested in continuing education.
Operate various lab instruments and equipment as an SME including (but not limited to): Karl Fisher, pH, HPLC, FTIR, UV-VIS, DSC, TOC, Lab-ware washers, Autoclave, Laminar Flow Hoods, Bio-Hazard Hood, Microbalances, and other diverse lab equipment and various wet chemistry techniques.
Lead method transfer activities by authoring, and executing protocols for compendial verifications, experimental testing, and method validation protocols.
Follow written protocols, SOPs, and directions from other lab scientists and manager.
Lead lyophilization development studies using (but not limited to) DSC, FDM, small-scale lyophilization, XRD, and supporting wet chemistry methods.
Follow company documentation SOPs to record and summarize laboratory findings in formal analytical methods reports.
Communicate project status to Sr. Pharmaceutical Scientists, QC/DEV Management, and Project Management personnel.
Monitor usage of laboratory supplies and chemicals, including glassware, equipment, materials, client drug substance/product, and excipients, and assist with material purchases.
General support required of a company where everyone is expected to perform multiple tasks both inside and outside their department to meet the needs of the business.
Technical writing ability to be the lead author on lab reports, SOPs, PM/SC documentation.
Analytical Development client representative for QC/DEV
Perform quality control analyses on a variety of equipment following formal written documentation, including SOPs, client methods, and compendial requirements.
Review experimental data, analytical data, and laboratory reports for accuracy.
Record and summarize work conducted and findings according to company documentation SOPs.
Comply with company and laboratory quality and safety management systems including requirements for documentation, training, system use, SOPs, and processes.
Primary analytical liaison between PPD and the laboratory for testing PPD study samples
Mentor associate scientists on diverse analytical methods applicable to parenteral product development, including HPLC, Karl Fischer, XRD, CE, UV Vis, and various wet chemistry techniques.
Support in the training of new QC/DEV staff to increase team strength and flexibility.
Promotes a highly professional working environment within the company.
Engage in effective teamwork between operating groups to lead the company towards meeting its goals and objectives.