Senior Scientist, Engineering

Job description

Job Description We aspire to be the premier research-intensive biopharmaceutical company. We're at the forefront of research to deliver innovative health solutions that advance the prevention and treatment of diseases in people and animals. Join our Chemical Commercialization Technology (CCT) department, part of our manufacturing division, and be part of a highly collaborative environment that provides substantial technical responsibility and leadership of internal and external work. The Chemical Commercialization Technology (CCT) department, which is part of our Company's Manufacturing Division, is seeking self-motivated individuals who are 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.  Given the significant role of biocatalysis and enzymes in the portfolio, the ideal candidate should have a specific expertise in microbial fermentation and downstream processing and is expected to draw on their expertise to optimize and fully characterize the enzyme manufacturing process control strategy across different scales.   The successful candidate will play a pivotal role in developing internal technical capabilities via mentoring junior staff and enhancing fermentation and downstream processing laboratory capabilities, in addition to supporting transfer of technologies to commercial manufacturing.  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). ResponsibilitiesDevelop safe and robust manufacturing processes through process characterization, technology transfer, validation, filing, and supply support of late-stage projects in the small molecule pipeline. Optimize and fully characterize the enzyme manufacturing process control strategy across different scales, leveraging expertise in microbial fermentation and downstream processing. Mentor junior staff and enhance fermentation and downstream processing laboratory capabilities. Support the transfer of technologies to commercial manufacturing. Utilize Quality Risk Management methodologies and tools for statistical design of experiments. Conduct hands-on experimentation at the laboratory bench and kilo lab scales. Ensure safety and quality compliance, including following current Good Manufacturing Practices (cGMPs), and participating in risk assessments, deviation investigations, and Good Documentation Practices (GDPs). QualificationsRequired PhD in Chemical Engineering, Bioprocess Engineering, Biological Engineering, Synthetic Biology, or a related field from an accredited college/university. Three years (3) of experience required in chemical, pharmaceutical, large molecule, or vaccine process development. Experience and knowledge in microbial fermentation and downstream process development and optimization, as well as process scale-up and scale-down. 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. Lead and operate within a cross-functional process development team. Preferred 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 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 (QbD) principles. Experience supporting/writing regulatory filings. . Required Skills: Adaptability, Biocatalysis, Biological Engineering, Bioprocess Engineering, Bioreactors, cGMP Regulations, Chemical Engineering, Chromatographic Techniques, Crystallizations, Design of Experiments (DOE), Detail-Oriented, Fermentation, Good Manufacturing Practices (GMP), Manufacturing Processes, Process Design, Process Development (PD), Process Optimization, Process Scale Up, Quality by Design, Regulatory Submissions, Small Molecule Drug Development, Small Molecule Synthesis, Synthetic Biology, Technology Transfer, Vaccine Development Preferred Skills: 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 The primary location for this posting is: USA - New Jersey - Rahway Where required by law, the compensation range for this role is provided below. The salary range for the primary location of this role is: $117,000.00 - $184,200.00 This range reflects the Company's reasonable expectation of the base salary applicable to this role at the time of posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. We offer a comprehensive package of benefits. Available benefits include medical, dental, vision healthcare and other insurance benefits (for employee and family), retirement ben