EyeBio
Overview
The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include analytical method development and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. Responsibilities
Analytical method development and validation in a cGMP environment Drug product testing and analytical investigations Drug product and manufacturing process characterization Drug product stability studies and specification development Manufacturing process scale-up and validation support Preparation of CMC documents for global regulatory submissions and responses to regulatory questions Collaborate in a dynamic, integrated, and multidisciplinary team environment Qualifications
Education Minimum Requirements: PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience Required Experience and Skills: Strong background and hands-on experience with UHPLC/HPLC, UV, IR spectroscopy, Karl Fischer titration, and dissolution Strong chemistry knowledge Demonstrated problem solving ability Excellent verbal and written communication skills, creativity, and strong interpersonal skills Ability to work in a team environment with cross-functional interactions Preferred Experience and Skills: Experience with pediatric formulation studies, including food and liquid in-use studies and troubleshooting methodologies Experience with method development and validation Familiarity with authoring relevant CMC sections of regulatory submissions Required Skills: Analytical Chemistry Analytical Development HPLC Karl Fischer Cross-functional collaboration Benefits and Compensation
The salary range for this role is $139,600.00 - $219,700.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available from the company’s compensation and benefits resources. Additional Information
U.S. and Puerto Rico Residents Only: We are committed to inclusion and provide accommodations in the hiring process if needed. As an Equal Employment Opportunity Employer, we 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. The company complies with affirmative action requirements for protected veterans and individuals with disabilities. Application details: You can apply for this role through the company careers site. The posting end date is indicated on the job posting.
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The Analytical Commercialization Technology (ACT) group within Analytical Chemistry in Development and Supply (ACDS) is seeking applicants for an Associate Principal Scientist position available at the Rahway, NJ and West Point, PA sites. The successful candidate will utilize innovative analytical characterization technologies to drive late-stage pharmaceutical drug product development and commercialization. The Associate Principal Scientist responsibilities include analytical method development and validation, drug product testing and analytical investigations in a cGMP environment, drug product and manufacturing process characterization, drug product stability studies, specification development, manufacturing process scale-up and validation support, preparation of Chemistry, Manufacturing, and Controls (CMC) documents for global regulatory submissions, and responses to regulatory questions. The successful candidate must be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. Responsibilities
Analytical method development and validation in a cGMP environment Drug product testing and analytical investigations Drug product and manufacturing process characterization Drug product stability studies and specification development Manufacturing process scale-up and validation support Preparation of CMC documents for global regulatory submissions and responses to regulatory questions Collaborate in a dynamic, integrated, and multidisciplinary team environment Qualifications
Education Minimum Requirements: PhD in Analytical Chemistry or related discipline with 4+ years of relevant pharmaceutical development experience or MS in Analytical Chemistry or related discipline with 10+ years of relevant pharmaceutical development experience Required Experience and Skills: Strong background and hands-on experience with UHPLC/HPLC, UV, IR spectroscopy, Karl Fischer titration, and dissolution Strong chemistry knowledge Demonstrated problem solving ability Excellent verbal and written communication skills, creativity, and strong interpersonal skills Ability to work in a team environment with cross-functional interactions Preferred Experience and Skills: Experience with pediatric formulation studies, including food and liquid in-use studies and troubleshooting methodologies Experience with method development and validation Familiarity with authoring relevant CMC sections of regulatory submissions Required Skills: Analytical Chemistry Analytical Development HPLC Karl Fischer Cross-functional collaboration Benefits and Compensation
The salary range for this role is $139,600.00 - $219,700.00. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits, including medical, dental, vision, retirement benefits (401(k)), paid holidays, vacation, and compassionate and sick days. More information about benefits is available from the company’s compensation and benefits resources. Additional Information
U.S. and Puerto Rico Residents Only: We are committed to inclusion and provide accommodations in the hiring process if needed. As an Equal Employment Opportunity Employer, we 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. The company complies with affirmative action requirements for protected veterans and individuals with disabilities. Application details: You can apply for this role through the company careers site. The posting end date is indicated on the job posting.
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