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Principal Pharmaceutical Scientist

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Job Description - Principal Pharmaceutical Scientist

Selects techniques to solve complex problems and makes sound design recommendations. Solid understanding on controlled drug release mechanism. Drug release and stability testing at internal and external laboratories Write CMC sections to support IDE and PMA submissions for combination products Participate in cross-functional product development teams and provide technical leadership to formulation development, test methods, sterilization process selection, packaging specification requirements, clinical manufacturing, quality assurance, analytical R&D, and regulatory affairs Consistently generates innovative and unique solutions to market needs and submits idea disclosures. Work is expected to result in the development of new or refined products, processes, or equipment. The selected candidate must have an ability to collaborate effectively with other scientists in a multidisciplinary team environment and possess excellent verbal and written communication skills. Ability to research literature and develop clinical understanding with technical credibility to develop a strategy for regulatory submission. Demonstrated ability to provide technical leadership on a large-scale development program. Providing technical direction to technicians/entry-level engineers, mentor junior level engineer Actively collaborating with process development, quality, manufacturing, regulatory, clinical, and marketing on complex projects to ensure project success. PhD in Pharmaceutical Sciences, Physical/Polymer Chemistry, Material Science, Chemical Engineering, Biomedical Engineering, or related technical field. 5 to 7 years of Medial Device, polymer materials or Pharmaceutical industry experience under a research and development environment. Strong hands-on capability and deep understanding of pharmaceutics and physical chemistry is a must. Understanding and experience in translation pre-clinical model development Knowledge of major analytical techniques such as HPLC, GC, LC/MS, GC/MS, and NMR are desirable. Strong interpersonal and communication skills Good technical writing skills Substantial knowledge in assay method development and validation and familiarity with drug release and stability testing are desirable. Good understanding of controlled drug delivery systems and ICH guidance are highly desirable Experience in practical lab-based Pharmacokinetics/Pharmacodynamics data analysis Must have critical thinking, curiosity and problem-solving skills In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures. Requisition ID: 620083 Minimum Salary: $ 99100 Maximum Salary: $ 188300 Compensation will be commensurate with demonstrable level of experience and training, pertinent education including licensure and certifications, among other relevant business or organizational needs. At BSC, it is not typical for an individual to be hired near the bottom or top of the anticipated salary range listed above. Compensation for non-exempt (hourly), non-sales roles may also include variable compensation from time to time (e.g., any overtime and shift differential) and annual bonus target (subject to plan eligibility and other requirements). Compensation for exempt, non-sales roles may also include variable compensation, i.e., annual bonus target and long-term incentives (subject to plan eligibility and other requirements). For MA positions: It is unlawful to require or administer a lie detector test for employment. Violators are subject to criminal penalties and civil liability. As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most - united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate. Now more than ever, we have a responsibility to apply those values to everything we do - as a global business and as a global corporate citizen. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you! That is why we stand for inclusion, equality, and opportunity for all. By embracing the richness of our unique backgrounds and perspectives, we create a better, more rewarding place for our employees to work and reflect the patients, customers, and communities we serve. To ensure full implementation of its equal employment policy, the Company will continue to take steps to assure that recruitment, hiring, assignment, promotion, compensation, and all other personnel decisions are made and administered without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information or any other protected class. Please be advised that certain US based positions, including without limitation field sales and service positions that call on hospitals and/or health care centers, require acceptable proof of COVID-19 vaccination status. Candidates will be notified during the interview and selection process if the role(s) for which they have applied require proof of vaccination as a condition of employment. As employees of the Company, you will be expected to meet the ongoing requirements for your roles, including any new requirements, should the Company's policies or protocols change with regard to COVID-19 vaccination. This role is deemed safety-sensitive and, as such, candidates will be subject to a prohibited substance test as a requirement. The goal of the prohibited substance testing is to increase workplace safety in compliance with the applicable law.
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