Quotient Sciences Limited
Senior Group Leader: Formulation Development
Quotient Sciences Limited, Garnet Valley, Pennsylvania, United States, 19060
Provides direction and oversight for product and process development, scale up protocol, and transfer activities for internal projects and between sites;Builds strong internal and external relationships with key stakeholders to facilitate project delivery and meet projects timeline;Participates in discussions with existing & potential clients to ensure effective dialogue;Manages detailed project plans with Lead Formulator and Project Management team to ensure clarity and attainment of milestones and timelines;Develops mitigation plans as needed to achieve project deliverables;Provides guidance to the Formulator to conduct pre-formulation, formulation, and manufacturing process development and oversees optimization for various solid dosage formulation and process development work;Identifies issues and facilitates problem solving, contingency planning, and decision making;Leads and ensures any quality investigations are completed in a timely manner to minimize interruption to supplies;Ensures timely review and approval of development and manufacturing documents such as development protocol, development report, manufacturing/ packaging batch record and DOE protocol;Supervises product development team members including administrative functions such as entering timecard information, interviewing candidates, performance evaluations, and training;Supports technical transfer from internal project to the process validation group and commercial group;Conducts routine checks to ensure proper GMP, and GDP compliance;Supervision of 3 Staff Formulator and 1 Manufacturing Scientist.
Minimum requirements:
Bachelor's degree, or foreign degree equivalent, in Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field, plus six (6) years of pharmaceutical industry experience in small molecule, oral drug product, or liquid and semisolid development and clinical manufacturing.
The experience (which may be gained concurrently) must include:
6 years of experience in designing and conducting de-formulation, pre-formulation and formulation studies, process development and optimization of solid dosage forms or liquid and semisolid development under cGMP conditions;6 years of experience in preparation of Manufacturing Batch records, Packaging Batch records, scale up protocols and reports, process validation protocols and reports, Hold time study protocols and reports, and Product Development reports for FDA;6 years of experience in development by using DOE, QBD and QBR approaches;6 years of experience in preparing and reviewing CMA, CQA, control strategy, and EMEA documents; and6 years of experience with each of the following pharmaceutical manufacturing processes: powder blending, liquid manufacturing, wet granulation, tablet coating, fluid bed drying, and compression/powder filling.
To apply, please forward resume to Yamel Gomez, People Coordinator at yamel.gomez@quotientsciences.com.
Minimum requirements:
Bachelor's degree, or foreign degree equivalent, in Chemical Engineering, Pharmacy, Pharmaceutical Sciences, or related field, plus six (6) years of pharmaceutical industry experience in small molecule, oral drug product, or liquid and semisolid development and clinical manufacturing.
The experience (which may be gained concurrently) must include:
6 years of experience in designing and conducting de-formulation, pre-formulation and formulation studies, process development and optimization of solid dosage forms or liquid and semisolid development under cGMP conditions;6 years of experience in preparation of Manufacturing Batch records, Packaging Batch records, scale up protocols and reports, process validation protocols and reports, Hold time study protocols and reports, and Product Development reports for FDA;6 years of experience in development by using DOE, QBD and QBR approaches;6 years of experience in preparing and reviewing CMA, CQA, control strategy, and EMEA documents; and6 years of experience with each of the following pharmaceutical manufacturing processes: powder blending, liquid manufacturing, wet granulation, tablet coating, fluid bed drying, and compression/powder filling.
To apply, please forward resume to Yamel Gomez, People Coordinator at yamel.gomez@quotientsciences.com.