Merck Sharp & Dohme
Senior Scientist, Oral Formulation Sciences (PSCS)
Merck Sharp & Dohme, Rahway, New Jersey, us, 07065
Job Description
Our company's Pharmaceutical Sciences and Clinical Supply organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.
The successful candidate will be a passionate Scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new chemical entities as part of a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.
Primary Responsibilities:
Propose new, innovative approaches for product development, generate experimental designs, execute experimental plans, and interpret data.
Support internal capability development by evaluating new technologies and deploying them to pipeline assets.
Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.
Execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.
Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups.
Outsource/coordinate formulation development or clinical manufacturing at Contract Development or Manufacturing Organizations.
Facilitate manufacturing, packaging, and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations.
Enhance our professional image and competitive advantage through patents, presentations, publications, and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations.
Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others.
Education Minimum Requirements:
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline. Bachelor of Science (B.S.) or Master of Science (M.S.) degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 6 years' relevant industrial experience.
Required Experience and Skills:
Proven ability to identify and develop innovative ideas.
Demonstrated ability to independently design and execute complex experiments and data analysis.
Ability to work effectively with team members of diverse skill sets and backgrounds.
Strong verbal and written communication skills.
Preferred Experience and Skills:
Pharmaceutical development experience.
Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development and optimization of novel production technologies.
Experience with advanced drug product manufacturing technologies, including: continuous manufacturing, three dimensional (3D) printing, controlled release, and/or oral delivery of large molecules.
Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector.
Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solving practical pharmaceutical development problems.
Hands-on experience in pharmaceutical pilot plants.
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Our company's Pharmaceutical Sciences and Clinical Supply organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench top to the Good Manufacturing Practice (GMP) manufacturing facilities, our Scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.
The successful candidate will be a passionate Scientist with strong academic fundamentals and a drive to develop new medicines to improve human health. In this role, the individual will be responsible for supporting the formulation development of new chemical entities as part of a matrix team from initial first in human formulations (suspensions, solutions, capsules, tablets) through final market formulation definition and manufacturing process robustness assessment.
Primary Responsibilities:
Propose new, innovative approaches for product development, generate experimental designs, execute experimental plans, and interpret data.
Support internal capability development by evaluating new technologies and deploying them to pipeline assets.
Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.
Execute formulation and process development activities using Design of Experiments for new chemical entities or life cycle management opportunities.
Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups.
Outsource/coordinate formulation development or clinical manufacturing at Contract Development or Manufacturing Organizations.
Facilitate manufacturing, packaging, and release of clinical supplies for clinical studies, assist in scale up activities at pilot and commercial scale, and summarize results in technical reports and presentations.
Enhance our professional image and competitive advantage through patents, presentations, publications, and professional activities and advance areas such as science and technology development, technical and business strategic improvements, business process innovations.
Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others.
Education Minimum Requirements:
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline. Bachelor of Science (B.S.) or Master of Science (M.S.) degree in Engineering, Pharmaceutical Sciences or related discipline with minimum of 6 years' relevant industrial experience.
Required Experience and Skills:
Proven ability to identify and develop innovative ideas.
Demonstrated ability to independently design and execute complex experiments and data analysis.
Ability to work effectively with team members of diverse skill sets and backgrounds.
Strong verbal and written communication skills.
Preferred Experience and Skills:
Pharmaceutical development experience.
Demonstrated ability to identify, fundamentally characterize, and address manufacturing challenges through the development and optimization of novel production technologies.
Experience with advanced drug product manufacturing technologies, including: continuous manufacturing, three dimensional (3D) printing, controlled release, and/or oral delivery of large molecules.
Experience with process modeling, simulation, and automation integration in the pharmaceutical and/or industrial manufacturing sector.
Desire to build new capabilities through the evaluation of new technologies and hands-on optimization of existing technologies.
Demonstrated ability to apply the principles of physical/organic chemistry, physical pharmacy, and materials science to solving practical pharmaceutical development problems.
Hands-on experience in pharmaceutical pilot plants.
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