Hispanic Alliance for Career Enhancement
Principal Scientist, Oral Formulation Sciences
Hispanic Alliance for Career Enhancement, Rahway, New Jersey, us, 07065
Overview
Our company's Pharmaceutical Sciences 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 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 leading CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization. Primary Responsibilities
Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction Mentor technical staff to develop team members scientifically and support the execution of pipeline programs Spearhead due diligence of potential pipeline assets and drug delivery technologies, including representing Pharmaceutical Sciences on cross-functional teams to make strategic and technical recommendations to leadership Set direction and coordinate technology development efforts in emerging drug delivery areas Drive evaluation of new technologies and leads capability build to deploy them to pipeline assets Collaborate effectively within and across functional areas to lead the development of novel drug delivery technologies Be recognized as a subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology Bring knowledge and creativity to the position and maintain discipline to drive results Independently execute formulation and process development activities using Design of Experiments for new chemical entities or lifecycle opportunities while coaching others Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups Lead project activities at external manufacturing sites 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 company's 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 Build and maintain awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and staff development Education Minimum Requirement
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience MS in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience BS in Engineering, Pharmaceutical Sciences or related discipline with minimum of 14 years relevant industrial experience Required Experience and Skills
Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across the company Extensive experience with conventional and novel drug product technologies, including hands-on experience to operate in a pilot plant and the ability to train others Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas Broad knowledge of formulation science and deep knowledge in multiple areas, including core understanding of the drug development process Demonstrated ability to independently design, execute and lead complex experiments and data analysis Track record of working effectively with team members of diverse skill sets and backgrounds Strong verbal and written communication skills Preferred Experience and Skills
Prior experience leading development projects at an enterprise level Strong mentoring capabilities to build individuals and teams Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology Demonstrated ability to identify, characterize and address manufacturing challenges through development and optimization of novel production technologies Desire to build new capabilities through evaluating new technologies and hands-on optimization of existing technologies Ability to engage others to build a strong scientific community and address drug delivery challenges Demonstrated ability to apply principles of physical/organic chemistry, physical pharmacy and materials science to solving practical pharmaceutical development problems U.S. and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work model consisting of three on-site days per week, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This model does not apply to remote roles. The salary range for this role is $169,700.00 - $267,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, retirement benefits (401(k)) and paid time off. More information about benefits: https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en. The application deadline is stated on the posting. Travel requirements: 10% We are an Equal Opportunity Employer and maintain compliance with applicable laws and regulations. Shop for roles carefully and ensure you meet the posted requirements before applying.
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Our company's Pharmaceutical Sciences 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 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 leading CMC project teams and the formulation development of new chemical entities through a matrix team from initial first in human formulations through final market formulation definition and manufacturing process robustness assessment. This individual will also be responsible for driving new technology strategy, scientific understanding and capability builds within the organization. Primary Responsibilities
Lead development of new, innovative approaches for product development, generation of experimental designs, execution experimental plans and data analysis to impact pipeline development and set strategic direction Mentor technical staff to develop team members scientifically and support the execution of pipeline programs Spearhead due diligence of potential pipeline assets and drug delivery technologies, including representing Pharmaceutical Sciences on cross-functional teams to make strategic and technical recommendations to leadership Set direction and coordinate technology development efforts in emerging drug delivery areas Drive evaluation of new technologies and leads capability build to deploy them to pipeline assets Collaborate effectively within and across functional areas to lead the development of novel drug delivery technologies Be recognized as a subject matter expert in at least one area of drug delivery and/or drug product manufacturing technology Bring knowledge and creativity to the position and maintain discipline to drive results Independently execute formulation and process development activities using Design of Experiments for new chemical entities or lifecycle opportunities while coaching others Coordinate development activities with process chemistry, preformulation, analytical, and physical characterization groups Lead project activities at external manufacturing sites 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 company's 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 Build and maintain awareness of relevant and emerging technologies and capabilities at a department level to develop institutional understanding and staff development Education Minimum Requirement
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 8 years relevant industry experience MS in Engineering, Pharmaceutical Sciences or related discipline with minimum of 10 years relevant industrial experience BS in Engineering, Pharmaceutical Sciences or related discipline with minimum of 14 years relevant industrial experience Required Experience and Skills
Capable of leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process Ability to lead complex teams in the development of new molecules and new technologies that shape drug delivery strategy across the company Extensive experience with conventional and novel drug product technologies, including hands-on experience to operate in a pilot plant and the ability to train others Recognized as a technical expert and scientific contributor with proven ability to identify and develop innovative ideas Broad knowledge of formulation science and deep knowledge in multiple areas, including core understanding of the drug development process Demonstrated ability to independently design, execute and lead complex experiments and data analysis Track record of working effectively with team members of diverse skill sets and backgrounds Strong verbal and written communication skills Preferred Experience and Skills
Prior experience leading development projects at an enterprise level Strong mentoring capabilities to build individuals and teams Recognized as a subject matter expert in multiple drug delivery and/or manufacturing technology Demonstrated ability to identify, characterize and address manufacturing challenges through development and optimization of novel production technologies Desire to build new capabilities through evaluating new technologies and hands-on optimization of existing technologies Ability to engage others to build a strong scientific community and address drug delivery challenges Demonstrated ability to apply principles of physical/organic chemistry, physical pharmacy and materials science to solving practical pharmaceutical development problems U.S. and Puerto Rico Residents Only: Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please click here if you need an accommodation during the application or hiring process. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other legally protected characteristics. As a federal contractor, we comply with affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights; EEOC GINA Supplement U.S. Hybrid Work Model: Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work model consisting of three on-site days per week, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence. This model does not apply to remote roles. The salary range for this role is $169,700.00 - $267,200.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision, retirement benefits (401(k)) and paid time off. More information about benefits: https://jobs.merck.com/us/en/compensation-and-benefits. You can apply for this role through https://jobs.merck.com/us/en. The application deadline is stated on the posting. Travel requirements: 10% We are an Equal Opportunity Employer and maintain compliance with applicable laws and regulations. Shop for roles carefully and ensure you meet the posted requirements before applying.
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