Senior Scientist - Supply Analytical Sciences (SAS)
PharmaCRORegulatory AffairsQuality Assurancegmpsasregulatory submissionemacrorave
Job description
Job Description Our company is currently seeking an exceptional individual for a technical leadership position within the Supply Analytical Sciences (SAS) - Analytical Chemistry in Development and Supply (ACDS) organization located at Rahway, NJ, USA. The successful candidate will join a group of innovative scientists with broad deliverables ranging from API and Drug Product analytical troubleshooting to driving lead-time reduction and efficiency gains. This role supports our company’s World Class Supplier and Operationalizing Quality goals. The Senior Scientist position is a laboratory-based scientific track role in a fast-paced, multidisciplinary team environment, focused on analytical deliverables associated with API/Drug Substance manufacture. Responsibilities Author analytical procedures, development and validation protocols and reports, technical reports, experimental designs, regulatory submission documents, etc. Perform investigations with strong technical troubleshooting skills. Provide documentation/technical input during inspections and audits (Regulatory and Internal) and have a working knowledge of data integrity. Evaluate analytical methods associated with the critical quality attributes of cGMP materials. Responsible for technical training of staff, as needed, on analytical techniques and problem solving once established within our department. Qualifications Required Master of Science (MS) in Chemistry or related discipline with at least eight (8) years of relevant pharmaceutical development experience; PhD in Analytical Chemistry or related discipline with two or more (2+) years of experience. Working knowledge of analytical techniques used in commercial testing of raw materials, intermediates, and drug substances. Strong verbal and written communication skills as well as flexibility to work in a dynamic environment (internal and external communications). Demonstrate strong interpersonal skills with flexibility and sensitivity in dealing with different cultures. Self-motivated to take ownership and accountability of issues and drive them to completion. Ability to quickly adapt to changes and develop appropriate plans for managing risks. Advanced knowledge of ALCOA+ principles. Must be able to travel on our company's behalf. Preferred Advanced experience developing various analytical techniques (e.g., chromatography, and spectroscopy) and product specification to support drug substance development and registration. Fundamental knowledge of synthetic (organic) chemistry. Advanced experience with API development and commercialization from an analytical perspective. Advanced experience working with contract manufacturing organizations and/or contract research organizations. Advanced experience working in cross-functional teams. Required Skills: Adaptability, Adaptability, Analytical Analysis, Analytical Chemistry, Analytical Method Development, Analytical Testing, Analytical Thinking, Chemical Proteomics, Chemical Synthesis, Chemistry, Chemometrics, Chromatographic Analysis, Chromatography, Commercialization, Cross-Functional Project Management, Data-Driven Decision Making, Data Integrity, Design of Experiments (DOE), Drug Delivery, Drug Formulations, Flow Cytometry, Mass Spectrometry Based Proteomics, Motivation Management, Pharmaceutical Sciences, Problem Identification {+ 10 more} 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 benefits, including 401(k), paid holidays, vacation, and compassionate and sick days. More information about benefits is available at https://jobs.merck.com/us/en/compensation-and-benefits . Additional location(s): Please note the salary range above applies to the Primary Location of the position. Where a role has other listed locations, different compensation guidelines may apply. You may find the sa
Stand out for this role
NoxPharm tailors your CV to this job description by aligning your experience with the role requirements and terminology. Built for pharma & life sciences.
Tailor my CV now — free to trySimilar Pharma jobs
Associate, Project Management (Pharmaceutical Labeling)
Open Scientific — Hauppauge, us
Maintenance Coordinator
Open Scientific — Bohemia, us
Manufacturing Operators - Pharmaceutical
Open Scientific — Melville, us
Pharmaceutical Mechanics - Packaging, Production, Maintanence
Open Scientific — Hauppauge, us
Warehouse - Pharmaceutical
Open Scientific — Hauppauge, us
Pharmaceutical Machine Operators
Open Scientific — Hauppauge, us