Associate Principal Scientist, Analytical Chemistry 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 West Point, PA and Rahway, NJ 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, but not limited to, 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.
The ideal candidate will have knowledge and proficiency in the following areas:
separation techniques and mass spectrometry.
Strong fundamental knowledge in recent advances in analytical technologies and small molecule degradation mechanisms is highly desired.
Applicants must have effective organizational skills, multi-tasking, oral and written communications skills.
Minimum Education Requirements and Experience:
Master of Science (MS) in Analytical Chemistry or related discipline with seven (7) years of relevant pharmaceutical and analytical development experience.
OR
PhD in Analytical Chemistry or related discipline with three (3) years of relevant pharmaceutical and analytical development experience
Required Experience and Skills:
Strong background and extensive hands-on experience with common analytical techniques such as Ultrahigh/High Performance Liquid Chromatography (UHPLC/HPLC), Gas Chromatography, Ultraviolet (UV) and Infrared (IR) spectroscopy, Karl Fischer titration, and dissolution.
Strong chemistry knowledge
Demonstrated problem solving ability
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills
Ability to work in a team environment with cross-functional interactions
Preferred Experience and Skills:
Experience with hyphenated analytical techniques such as LC/MS and GC/MS with proven ability in troubleshooting these methodologies
Experience with method development and validation
Familiarity with authoring relevant CMC sections of regulatory submissions
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 applicable legally protected characteristics.
As a federal contractor, we comply with all 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:
We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds.
The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills come together in an inclusive environment.
We encourage our colleagues to respectfully challenge one another's thinking and approach problems collectively.
Effective September 5, 2023, employees in office-based positions in the U.
will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, 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 Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely.
Please note, this Hybrid work model guidance also does not apply to roles that have been designated as 'remote'.
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States.
Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$139,600.
00 - $219,700.
00
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 West Point, PA and Rahway, NJ sites.
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