Principal Scientist, Chemical Engineering R&D The Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking highly motivated individuals who are looking for an opportunity to work in a fast-paced job that provides a high degree of technical leadership and mentoring. This position leverages significant depth and breadth of scientific and technical experience to lead small molecule drug substance process development teams to develop safe, robust and productive processes, through scale-up, tech transfer, process characterization, validation and filing. This role involves hands-on process development at the laboratory bench and kilo lab scales, in addition to support of and scale-up to pilot plant and commercial manufacturing scales. The candidate will also provide mentoring and scientific direction to develop junior staff to design, plan, and implement advanced experiments aimed at achieving research goals related to process development, technology development, and production of active pharmaceutical ingredients (API). The candidate may also have the opportunity to manage process development and/or manufacturing activities at external suppliers. The engineer will be expected to exhibit a mindset of safety and quality compliance, which will include following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). A high level of innovation, creativity, and self-initiative along with the ability to plan and organize activities are expected. Successful candidates will be required to communicate regularly, clearly, and effectively as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers. Education Minimum Requirement: The position requires either a BS and/or MS in Chemical/Biochemical Engineering (or comparable) from an accredited college/university plus at least 11 years of relevant work experience in process development, or a PhD in Chemical/Biochemical Engineering (or comparable) from an accredited college/university with at least 6 years of relevant work experience post PhD defense. Required Experience and Skills:
- For BS/MS candidates, at least 11 years of relevant work experience post-graduation - OR - for PhD candidates with at least 6 years of relevant work experience post PhD defense, where relevant work experience would include the following:
- Experience performing lab-based research/process development including performing unit operations common in small molecule drug substance process development such as chemical reactions, work-up, and crystallization.
- Demonstrations of successful chemical process scale-up and technology transfer, moving from laboratory to pilot plant or production scale.
- Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity.
- Ability to mentor technical staff in the laboratory and through data analysis.
- Highly effective communication and collaboration skills.
- Good organizational, interpersonal, writing, and time management skills.
- Lead and operate within a cross-functional process development team. Preferred Experience and Skills:
- Direct experience with pharmaceutical drug development.
- Knowledge of concepts and application of ICH, cGMP and GDP during pharmaceutical drug substance development and production.
- Experience with enabling technologies in chemical processing, such as bio/chemo-catalysis, continuous processing, and/or particle engineering.
- Experience applying statistical experimental design (i.e. Design of Experiments), data-rich experimentation, process modeling, and data analysis.
- Experience with chemical engineering-related technology development.
- Experience with risk assessments, process characterization, validation, and regulatory authoring.
- Proven track record of technical innovation and sharing of this work internally and externally via publications and conference presentations. NOTICE FOR INTERNAL APPLICANTS: In accordance with Managers' Policy - Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior to applying for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. US 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. We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. Expected US salary range: $164,800.00 - $259,400.00 Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. Employee Status: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Shift: 1st - Day Job Posting End Date: 11/1/2024 #J-18808-Ljbffr