Senior Scientist, Small Molecule Chemical Engineering

MSD•Rahway, NJ

8d•$117,000 - $184,200

About The Position

The Chemical Commercialization Technology (CCT) department, which is part of our 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 Senior 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. 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).

Requirements

BS and/or MS with a minimum of 5 years relevant work experience or PhD in Chemical Engineering from an accredited college/university.
Relevant work experience in chemical process development.
Demonstrated capability to develop and execute an experimental program to address issues of process design, robustness and productivity.
Highly effective communication and collaboration skills.
Good organizational, interpersonal, writing, and time management skills.
Ability to operate within a cross-functional process development team.
cGMP Regulations
Chemical Engineering
Chemical Manufacturing
Chemical Processes
Chromatographic Techniques
Design of Experiments (DOE)
Process Characterization
Process Scale Up
Reaction Engineering
Small Molecule Synthesis
Technology Transfer

Nice To Haves

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.
Experience with process scale-up and technology transfer, moving from laboratory to pilot plant or factory.
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.
Current Employees apply HERE
Current Contingent Workers apply HERE
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.
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: EEOC Know Your Rights EEOC GINA Supplement
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. Learn more about your rights, including under California, Colorado and other US State Acts
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
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.

Responsibilities

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.
Provide scientific expertise by learning and utilizing Quality Risk Management methodologies and tools for statistical design of experiments.
Conduct hands-on experimentation at the laboratory bench and kilo lab scales.
Manage technology transfer to commercial manufacturing facilities.
Exhibit a mindset of safety and quality compliance, including following current Good Manufacturing Practices (cGMPs).
Participate in risk assessments, deviation investigations, and Good Documentation Practices (GDPs).