Associate Principal Scientist, Engineering

** Job Description
** The Chemical Commercialization Technology (CCT) department, which is part of our company Manufacturing Division is seeking a self-motivated individual who is looking for an opportunity to work in a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work.

The Associate Principal Scientist, Engineering position leverages scientific/technical experience to develop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small molecule pipeline. The candidate will provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments. This role involves hands-on experimentation at the laboratory bench and kilo lab scales in addition to technology transfer to commercial manufacturing facilities.

Mentoring is required to develop junior staff to initiate, plan and execute characterization and complete technical support objectives. The scientist 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).  
** Position

Qualifications:

**** Education Minimum Requirement:
*** The position requires a BS and/or MS in Chemical Engineering or a related field from an accredited college/university plus at least 8 years of relevant work experience in process development or PhD with at least 4 years of relevant work experience post PhD defense.
** Required

Experience and Skills:

** Relevant work experience in chemical process development, including the following:
* Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity
* Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory
* 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
* Ability to operate within a cross-functional process development team
** Preferred

Experience and Skills:

*** 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
* Experience leading regulatory file authoring, validation planning and execution
* Experience guiding internal/external technical discussions
* Familiarity with statistical design and analysis tools
* Familiarity with concepts and application of current Good Manufacturing Practices (cGMPs) ideally during pharmaceutical drug substance / drug product development and production, e.g. in a pilot and/or factory setting
* Experience with mathematical modeling, theoretical scaling calculations, and Quality by Design principles.
*
* Required Skills:

** Bioprocessing, Chemical Engineering, Chemical Technology, Data Analysis, Detail-Oriented, Maintenance Supervision, Manufacturing Process Validation, Manufacturing Quality Control, Manufacturing Scale-Up, Protein Purifications, Regulatory Submissions, Technical Writing
** Preferred

Skills:

** Current Employees apply

Current Contingent Workers apply
** 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  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…