Senior Product Development Scientist

Singota Solutions•Bloomington, IN

16h

About The Position

The role of the Senior Product Development Scientist includes the following key functions carried out in according to the company vision, mission, standards, goals, objectives, and strategic direction: Responsible for client specific and internal projects associated with product formulations optimization, scale up, and design of the process for clinical manufacturing. Works integrated with the Analytical, Product and Process Development groups, communicates and presents scientific outcomes at internal and external forums. Collaborates with Business Development and Client Services to manage client opportunities. Serves and supports Singota operations as a subject matter expert for Product Development functions. Mentor Scientists and invested in continuing education. Accountable for client specific and internal activities associated with product formulations optimization, scale up and process design and readiness for clinical manufacturing: Designs and executes pre -formulation, formulation, and sterile product processes development studies. Identifies and performs the analytical testing associated with formulation screening and selection. Develops and executes protocols associated with method evaluation, optimization of liquid and lyo formulations, product presentations (vial, syringe, cartridge etc.) and in -use product requirements. Designs product fit for purpose compatibility and stability protocols Summarizes results and share outcomes of the studies using best documentation practices. Works with Lab manager to manage testing protocols, method transfer processes. Develops and refines tools, systems, SOPs, and processes needed in alignment with R&D and Ops priorities. Works integrated with Lab and Process Development leaders to assist with execution and documentation of testing protocols and method development processes and testing parameters. Performs data analytics to provide useful information, inform conclusions, and support decisions. Maintains awareness of industry technical trends and application for innovative techniques. Recommends laboratory capabilities with industry needs and technological advancements. Collaborates with Business Development and Client Services to manage client opportunities: Contributes to sessions associated with ongoing and incoming projects to ensure alignment with the project plans at Singota. Summarizes laboratory findings timely in presentations and formal reports provided to clients. Represents Singota at external events, including but not limited to Conferences, seminars, webinars, etc. Assists in the writing, planning and executing of formulation/method development projects for clients. Provides timely and accurate communications/updates to Project Managers, BD, or Management. Supports client/regulatory visits and audits of the laboratory. Regarded as Subject Matter Expert within the pharmaceutical development and method development arena. Assists in onboarding of new client projects into manufacturing. Authors and reviews APPD standard operating procedures. Serves and supports Singota operations as a subject matter expert for Product Development functions: Participates in knowledge generation and integration. Study industry best practices and build knowledge of industry trends. Collaborates on implementing best practices. Identifies process improvements. Leads the planning, implementation, and track metrics of process improvements in the Product Development organization. Support the client team in organizing and leading meetings. Drive projects to meet operational deliverables by delivering all project work on time with a high level of quality. Balance multiple projects Mentors scientists and is invested in continuing education: Mentor pharmaceutical scientists on diverse analytical and bioanalytical methods applicable to parenteral product development, including but not limited to HPLC, Karl Fischer, CE, UV -Vis, and various wet chemistry techniques. Participates and is an advocate in training of new staff to increase team strength and flexibility. Promotes a highly professional working environment within and outside the company. Actively promote and engage in effective teamwork between operating groups, collaborating with other managers and directors to lead the company towards meeting its goals and objectives. General: Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures 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.

Requirements

Strong interest and commitment to exceptional customer service and teamwork by engaging remotely and executing timely or proactively on tasks important to clients and internal customers.
Highly motivated, independent and self -directed work ethic; good judgement 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, audits, 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 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.
PhD in pharmaceutics, chemistry, or in a related field with at least 5 years of relevant experience OR
Masters in pharmaceutics, chemistry, or in a related field with at least 7 years of relevant experience OR
Bachelors in chemistry, biology, or in a related field with at least 10 years of relevant experience
Minimum of 10 years of relevant laboratory experience
Minimum of 7 years pharmaceutical and/or life science experience, or equivalent education/experience
Minimum of 5 year of formulation development experience for pharmaceutical drug products
Verbal presentation skills – small and large group presentations with prospective clients
Ability to author formulation, testing service proposals, written communications, and reports
Experience with GMP, GLP, and R&D documentation and analytical testing

Responsibilities

Responsible for client specific and internal projects associated with product formulations optimization, scale up, and design of the process for clinical manufacturing.
Works integrated with the Analytical, Product and Process Development groups, communicates and presents scientific outcomes at internal and external forums.
Collaborates with Business Development and Client Services to manage client opportunities.
Serves and supports Singota operations as a subject matter expert for Product Development functions.
Mentor Scientists and invested in continuing education.
Accountable for client specific and internal activities associated with product formulations optimization, scale up and process design and readiness for clinical manufacturing
Designs and executes pre -formulation, formulation, and sterile product processes development studies.
Identifies and performs the analytical testing associated with formulation screening and selection.
Develops and executes protocols associated with method evaluation, optimization of liquid and lyo formulations, product presentations (vial, syringe, cartridge etc.) and in -use product requirements.
Designs product fit for purpose compatibility and stability protocols
Summarizes results and share outcomes of the studies using best documentation practices.
Works with Lab manager to manage testing protocols, method transfer processes.
Develops and refines tools, systems, SOPs, and processes needed in alignment with R&D and Ops priorities.
Works integrated with Lab and Process Development leaders to assist with execution and documentation of testing protocols and method development processes and testing parameters.
Performs data analytics to provide useful information, inform conclusions, and support decisions.
Maintains awareness of industry technical trends and application for innovative techniques. Recommends laboratory capabilities with industry needs and technological advancements.
Contributes to sessions associated with ongoing and incoming projects to ensure alignment with the project plans at Singota.
Summarizes laboratory findings timely in presentations and formal reports provided to clients.
Represents Singota at external events, including but not limited to Conferences, seminars, webinars, etc.
Assists in the writing, planning and executing of formulation/method development projects for clients.
Provides timely and accurate communications/updates to Project Managers, BD, or Management.
Supports client/regulatory visits and audits of the laboratory.
Regarded as Subject Matter Expert within the pharmaceutical development and method development arena.
Assists in onboarding of new client projects into manufacturing.
Authors and reviews APPD standard operating procedures.
Participates in knowledge generation and integration.
Study industry best practices and build knowledge of industry trends. Collaborates on implementing best practices.
Identifies process improvements. Leads the planning, implementation, and track metrics of process improvements in the Product Development organization.
Support the client team in organizing and leading meetings.
Drive projects to meet operational deliverables by delivering all project work on time with a high level of quality.
Balance multiple projects
Mentor pharmaceutical scientists on diverse analytical and bioanalytical methods applicable to parenteral product development, including but not limited to HPLC, Karl Fischer, CE, UV -Vis, and various wet chemistry techniques.
Participates and is an advocate in training of new staff to increase team strength and flexibility.
Promotes a highly professional working environment within and outside the company.
Actively promote and engage in effective teamwork between operating groups, collaborating with other managers and directors to lead the company towards meeting its goals and objectives.
Comply with quality and safety management systems including requirements for documentation, training, system use, SOPs, processes and procedures
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.