Hispanic Alliance for Career Enhancement
Associate Principal Scientist, Oral Formulation Sciences
Hispanic Alliance for Career Enhancement, Rahway, New Jersey, us, 07065
Overview
Our company's Pharmaceutical Sciences & Clinical Supplies 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 leading the formulation development of new chemical entities as part of a matrix team from initial first in human formulations through final market formulation definition and manufacturing process robustness assessment.
Primary Responsibilities
Lead development of new, innovative approaches for product development, generation of experimental designs, execution of experimental plans and data analysis.
Drive evaluation of new technologies and lead capability build to deploy them to pipeline assets.
Collaborate effectively within and across functional areas and be a recognized 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 management opportunities, while coaching others in a collaborative environment.
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 the company’s professional image and competitive advantage through patents, presentations, publications and professional activities, and advance science and technology development and related improvements.
Maintain awareness of relevant new technologies, capabilities, and share this knowledge with others.
Education Minimum Requirement
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant drug product development experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with a minimum of 10 years relevant industrial experience.
Required Experience and Skills
Prior experience leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process.
Experience with conventional and novel drug product technologies to develop pipeline assets, including hands-on experience to independently operate in a pilot plant and the ability to train others in the department.
Scientific contributor with proven ability to identify and develop innovative ideas.
Broad knowledge of formulation science with in-depth knowledge in multiple areas, including core understanding of the drug development process.
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.
Ability to mentor individuals in a peer-to-peer and technical mentorship capacity.
Recognized subject matter expert in at least one drug delivery and/or manufacturing technology.
Ability to identify, characterize and address manufacturing challenges through development and optimization of novel production technologies.
Desire to build new capabilities through evaluation of new technologies and optimization of existing technologies.
Demonstrated application of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.
Breadth of experience across related functional areas, including Pharmaceutical Operations, Analytical Sciences, and Commercialization.
US and Puerto Rico Residents Only: Our company is committed to inclusion and provides accommodations during the application process if needed. Equal Employment Opportunity statement and related information are provided for transparency about rights under EEO laws. See external links and notices included in the posting for more details.
Additional Information Current Employees apply HERE. Current Contingent Workers apply HERE. The salary range for this role is $139,600.00 - $219,700.00 and includes eligibility for annual bonus and long-term incentive, if applicable. The company offers a comprehensive benefits package and a Hybrid Work Model in the U.S. (three on-site days per week with Friday remote, subject to site requirements).
Geographic and local compliance notes: San Francisco and Los Angeles residents may be eligible for local ordinances regarding fair chance hiring and related protections. See posted policies for full details.
To apply, visit the company careers site. The posting includes a legal notice about recruitment practices and travel expectations (approx. 10%). This posting ends on 10/31/2025.
#J-18808-Ljbffr
Our company's Pharmaceutical Sciences & Clinical Supplies 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 leading the formulation development of new chemical entities as part of a matrix team from initial first in human formulations through final market formulation definition and manufacturing process robustness assessment.
Primary Responsibilities
Lead development of new, innovative approaches for product development, generation of experimental designs, execution of experimental plans and data analysis.
Drive evaluation of new technologies and lead capability build to deploy them to pipeline assets.
Collaborate effectively within and across functional areas and be a recognized 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 management opportunities, while coaching others in a collaborative environment.
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 the company’s professional image and competitive advantage through patents, presentations, publications and professional activities, and advance science and technology development and related improvements.
Maintain awareness of relevant new technologies, capabilities, and share this knowledge with others.
Education Minimum Requirement
Ph.D. in Chemical Engineering, Biomedical Engineering, Pharmaceutical Sciences or related discipline with a minimum of 4 years relevant drug product development experience. B.S. or M.S. degree in Engineering, Pharmaceutical Sciences or related discipline with a minimum of 10 years relevant industrial experience.
Required Experience and Skills
Prior experience leading formulation development activities in matrix team environments to define a robust formulation and manufacturing process.
Experience with conventional and novel drug product technologies to develop pipeline assets, including hands-on experience to independently operate in a pilot plant and the ability to train others in the department.
Scientific contributor with proven ability to identify and develop innovative ideas.
Broad knowledge of formulation science with in-depth knowledge in multiple areas, including core understanding of the drug development process.
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.
Ability to mentor individuals in a peer-to-peer and technical mentorship capacity.
Recognized subject matter expert in at least one drug delivery and/or manufacturing technology.
Ability to identify, characterize and address manufacturing challenges through development and optimization of novel production technologies.
Desire to build new capabilities through evaluation of new technologies and optimization of existing technologies.
Demonstrated application of physical/organic chemistry, physical pharmacy & materials science to solving practical pharmaceutical development problems.
Breadth of experience across related functional areas, including Pharmaceutical Operations, Analytical Sciences, and Commercialization.
US and Puerto Rico Residents Only: Our company is committed to inclusion and provides accommodations during the application process if needed. Equal Employment Opportunity statement and related information are provided for transparency about rights under EEO laws. See external links and notices included in the posting for more details.
Additional Information Current Employees apply HERE. Current Contingent Workers apply HERE. The salary range for this role is $139,600.00 - $219,700.00 and includes eligibility for annual bonus and long-term incentive, if applicable. The company offers a comprehensive benefits package and a Hybrid Work Model in the U.S. (three on-site days per week with Friday remote, subject to site requirements).
Geographic and local compliance notes: San Francisco and Los Angeles residents may be eligible for local ordinances regarding fair chance hiring and related protections. See posted policies for full details.
To apply, visit the company careers site. The posting includes a legal notice about recruitment practices and travel expectations (approx. 10%). This posting ends on 10/31/2025.
#J-18808-Ljbffr