This role is for our Purification team in the Downstream area within the Vaccine Process Development and Commercialization (V-PDC) group which is in our Company's Manufacturing Division. V-PDC focuses on late stage process development, technology transfer, and in-line support of vaccine products. We seek an energetic, people-oriented leader with strong scientific, and technical skills to lead development, and commercialization activities supporting multiple vaccine programs.
In this role, you will be responsible for:
Leading process development activities to execute large molecule upstream and/or downstream processing, including lab-scale process development, in-process assay support, and process scale-up/scale-down.
Execution of lab scale experiments, and authoring associated technical reports and documents.
Collaborating with commercial manufacturing teams to support facility start-up activities, and provide on-the-floor support for drug substance manufacturing, both within the our Company network and at contract manufacturing organizations (CMOs).
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.
Provide mentor-ship and technical direction to other members of the team which may include dotted-line reporting relationships.
Education Minimum Requirement:
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.
Hands-on expertise in execution of process development with multiple programs and unit operations across upstream and/or downstream unit operations.
Expertise in lab-scale experimental execution, and experience with Design of Experiments (DOE), statistical data analysis, and presentation of results/conclusions.
Experience authoring technical documentation to support regulatory submissions.
Outstanding communication and people skills.
Ability to foster a collaborative work environment focused on mentor-ship, coaching, and Subject Matter Expertise.
Subject Matter Expert development.
Experience with project strategic planning.
Knowledgeable in Drug Substance end-to-end process development.
Proficiency with downstream unit operations, including chromatography.
Strong cross-functional background, enabling teams to reach peak performance.
Ability to provide scientific mentor-ship and guidance to technical coworkers and colleagues within and outside our Company
Project management experience with the ability to lead teams
Experience with downstream unit operation mathematical modeling, theoretical scaling calculations, and computational fluid dynamics (CFD) modeling.
Experience with large molecule assay development and/or execution.
Experience with Quality by Design (QbD), Lean Six Sigma principles
Experience supporting/writing regulatory filings (IND, MAA, BLA) and inspections with multiple agencies (FDA, EMA, JNDA, TGA) .
Experience with on-the-floor Good Manufacturing Practice (GMP) manufacturing support including providing immediate responses on the shop floor to deviations and potential deviations.
Our Manufacturing & Supply Division is committed to be the most trusted supplier of bio-pharmaceuticals worldwide. Our facilities, along with our external contractors, suppliers, and partners, create an interdependent global manufacturing network that's committed to delivering a high quality, reliable supply to customers and patients on time, every time.
Who we are
Merck & Co., Inc., Kenilworth, New Jersey, USA is known as "Merck" in the United States, Canada & Puerto Rico. We are known as "MSD" in Europe, Middle East, Africa, Latin America & Asia Pacific. We are a global biopharmaceutical leader with a diverse portfolio of prescription medicines, oncology, vaccines and animal health products.
We are driven by our purpose to develop and deliver innovative products that save and improve lives. With 69,000 employees operating in more than 140 countries, we offer state of the art laboratories, plants and offices that are designed to Inspire our employees as we learn, develop and grow in our careers. We are proud of our 125 years of service to humanity and continue to be one of the world's biggest investors in Research & Development.
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.
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 to applying 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.
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Merck & Co., Inc.