Job DescriptionThe Chemical Engineering Research & Development department (CERD), part of the Process Research and Development organization, is seeking a highly motivated and technically focused individual to lead the Crystallization Lab. Through direct, lab-based contributions and scientific supervision of a team of crystallization subject matter experts, the Crystallization Lab Lead collaborates with cross-functional teams to ensure small molecule Active Pharmaceutical Ingredient (API) processes meet target yield, purity, and physical attributes for clinical programs across the diverse pipeline. As a recognized expert in the field of crystallization and solid-state chemistry, this role offers the unique opportunity to influence crystallization and drying process development strategies that span early-phase API deliveries and commercial supply. The candidate may also have the opportunity to manage crystallization development and/or crystallization manufacturing activities at external suppliers. The Crystallization Lab Lead 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, and Good Documentation Practices (GDPs).
In addition to supporting pipeline activities, the Crystallization Lab Lead is responsible for identifying and developing innovative processes and technologies aimed at improving the performance and efficiency of crystallizations, providing enhanced process knowledge, and integrating particle engineering approaches to realize desired API physical properties across scales. Serving as a steward for scientific excellence, the Crystallization Lab Lead advocates technical growth opportunities through collaboration with internal resources and academic or industrial partnerships. In partnership with the Director of Chemical Engineering R&D, the Crystallization Lab Lead also plays a key role in talent management of junior engineers while driving departmental initiatives.
A high level of innovation, creativity, and self-initiative along with the ability to balance and prioritize activities across multiple projects are expected. Successful candidates will be required to communicate regularly, clearly, and with confidence as they discuss technical problems, support pilot plant operations, and interface with cross-functional colleagues/customers in drug substance, drug product, and material science. Mentoring chemistry and engineering colleagues to share best practices and guide their development toward efficiently achieved successful outcomes is a central expectation of the role.
Position Qualifications: 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 15 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 10 years of relevant work experience post PhD defense.
Required Experience and Skills:- For BS/MS candidates, at least 15 years of relevant work experience post-graduation - OR - for PhD candidates with at least 12 years of relevant work experience post PhD defense, where relevant work experience would include the following:
- Experience performing lab-based crystallization development and/or solid-state analysis.
- Experience with process scale-up and technology transfer of small molecule crystallization, moving from laboratory to pilot plant or production scale.
- Experience with drug product processing and experience collaborating across the drug substance / drug product interface.
- Experience with crystallization Process Analytical Tools (e.g., FTIR, FBRM, Raman, image analysis), common off-line analytical techniques (e.g., HPLC, GC, SEM, NMR), and data-rich experimentation concepts, practices, and equipment.
- Proven track record for scientific excellence that includes scientific publications and external conference presentations, as well as commercialization of crystallization processes.
- Technical leadership experience, including examples of mentoring technical staff in the laboratory.
- 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:- Experience with drying process development, optimization, and scale-up.
- Experience with developing crystallizations to control and optimize the purity profile of API and intermediates by applying mechanistic understanding of impurity rejection.
- Experience with technology development to enhance crystallization processes, such development of crystallization models, process intensification technology to improve crystallization robustness, continuous crystallization platforms, and crystallization data analytics.
- Experience with concepts and application of cGMP and GDP during pharmaceutical development and production, across multiple scales on multiple projects.
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U.S. Hybrid Work ModelEffective September 5, 2023, employees in office-based positions in the U.S. 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:
$187,000.00 - $294,400.00
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. A summary of benefits is listed here.
San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance
Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance
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Employee Status: Regular
Relocation:VISA Sponsorship:Travel Requirements:Flexible Work Arrangements:Not Applicable
Shift:Valid Driving License:Hazardous Material(s):Job Posting End Date:02/17/2025
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