Senior Scientist, Vaccine Process Development and Commercialization

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Location :
West Point, Pennsylvania

Expiry Date :
Mon, 14 Dec 2020 23:59:59 GMT

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Job Details Full-timeEstimated: $69,000 – $92,000 a year11 hours ago Benefits – Health insurance Qualifications – Strategic planning – CGMP – Communication skills – Manufacturing – Data analysis skills – Bachelor’s degree – Doctoral degree – Master’s degree Full Job Description Job Description Our Engineers support internal and external manufacturing operations remain operational, continuously improve and innovate. With our extensive range of facilities and environments, our Engineers have opportunities across many diverse areas including Biological, Chemical, Automation, Capital Projects, Maintenance, Safety, Process Development, Technical Services, Utilities and Validation. The Vaccine Process Development and Commercialization (VPDC) group within our Company’s Manufacturing Division focuses on late stage process development, technology transfer, and in-line support of vaccine products (live-attenuated vaccines, inactivated vaccines, subunit, recombinant, polysaccharide, and conjugate vaccines). We are committed to keeping pace with the ever-evolving infectious disease landscape by researching and developing vaccine candidates for important diseases. We seek people-oriented leaders with strong scientific and technical skills to lead the development and commercialization activities supporting multiple vaccine programs in late stage development. Primary Responsibilities Leading process development activities to execute large molecule upstream processing including lab-scale process development and process scale-up/scale-down Executing lab scale experiments and authoring associated technical reports and documents Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner Authoring and/or reviewing technical documents to support Process Performance Qualification (PPQ) and licensure Collaborating with commercial manufacturing teams to support facility start-up activities and provide on-the-floor support for drug substance manufacturing, both within our Company’s network and at contract manufacturing organizations (CMOs) Leading assignment execution against accelerated, critical-path timelines in a right-first-time manner Provide mentor-ship, coaching, and technical direction to other members of the team which may include direct reporting relationships Education Minimum Requirement Bachelor of Science in Chemical Engineering, Biochemical Engineering, Bio-engineering, Pharmaceuticals, Biochemistry, Microbiology, or related field with 6+ years of relevant experience; OR Master degree with 4+ years of relevant experience; OR Ph.D. with relevant experience Required Experience and Skills Large molecule process development, or relevant experience including scaling (up and down) and tech transfer of large molecule drug substance processes Good understanding of cellular physiology and metabolism and ability to correlation to in-lab or shop floor events Small, lab or pilot-scale bioreactors Lab scale experimental execution and experience with statistical data analysis and presentation of results/conclusions Authoring technical documentation Outstanding communication and people skills Project strategic planning Outstanding communication and people skills Current Good Manufacturing Practice (cGMP) Preferred Experience and Skills Knowledgeable in Drug Substance, end-to-end process development, including microbial, live virus vaccine, gene therapy, or oncolytic virus processes Downstream unit operation mathematical modeling, theoretical scaling calculations, computational fluid dynamics (CFD) modeling Quality by Design (QbD) and Lean Six Sigma principles Ability to provide scientific mentor-ship and guidance to technical coworkers Supporting/writing regulatory filings (IND, MAA, BLA) and supporting inspections with multiple agencies (FDA, EMA, JNDA, TGA) Good Manufacturing Practice (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations Our Manufacturing & Supply Division is dedicated to being the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create a reliable global manufacturing network that’s devoted to delivering a high quality, reliable supply to customers and patients on time, every time. Who we are . We are known as Merck & Co., Inc., Kenilworth, New Jersey, USA in the United States and Canada and MSD everywhere else. For more than a century, we have been inventing for life, bringing forward medicines and vaccines for many of the world’s most challenging diseases. Today, our company continues to be at the forefront of research to deliver innovative health solutions and advance the prevention and treatment of diseases that threaten people and animals around the world. What we look for . In a world of rapid innovation, we seek brave Inventors who want to make an Impact in all aspects of our business, enabling breakthroughs that will affect generations to come. We encourage you to bring your disruptive thinking, collaborative spirit and diverse perspective to our organization. Together we will continue Inventing For Life, Impacting Lives while Inspiring Your Career Growth. INVENT. IMPACT. INSPIRE. NOTICE FOR INTERNAL APPLICANTS In accordance with Managers’ Policy – Job Posting and Employee Placement, all employees subject to this policy are required to have a minimum of twelve (12) months of service in current position prior toing for open positions. If you have been offered a separation benefits package, but have not yet reached your separation date and are offered a position within the salary and geographical parameters as set forth in the Summary Plan Description (SPD) of your separation package, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor. US and Puerto Rico Residents Only: If you need an accommodation for the application process please email us at Show full job description Apply Now