Biologics and Vaccines Analytics (BVA), in our Manufacturing Division, is responsible for the commercialization of vaccine analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine availability.
Our Company has an expansive vaccines portfolio and an exciting pipeline of human health vaccine candidates. This position will be part of a manufacturing organization that brings these vaccines to people around the world.
The BVA team is highly motivated, fast-paced and focused on the rapid advancement of our Company vaccines pipeline, plus growth of existing products.
The Associate Principal Scientist will be responsible for leading analytical development, scale-up, optimization, and commercialization for late-stage vaccines programs, and to develop the analytical life-cycle management strategy for these programs.
In this role you will interact with and influence numerous functions across the late stage development and commercialization areas (such as clinical, process development, quality control, quality assurance, technical operations, value chain management).
You will be expected to show deep technical knowledge in analytical method development and validation (experience with cell-based assay and scale-up of laboratories strongly preferred), as well as the demonstrated ability to excel in complex cross-functional team settings and to proficiently manage very aggressive program timelines.
Education Minimum Requirement:
- B.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 10+ years of relevant industry experience;
- M.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 6+ years of relevant industry experience;
- Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 3+ years of relevant industry experience.
Required Experience and Skills:
- Experience with late stage method development, validation, transfer, and trouble-shooting.
- At least 3 years working experience in a current Good Manufacturing Practices (cGMP) laboratory environment in the area of large molecules (vaccines, biologics) with experience in immunochemical, chromatography-based, and cell-based analytical methods.
- Experience with drug substance and drug product release, stability and extended characterization testing for vaccines and biologics.
- Ample experience with analytical method development, validation and transfer.
- Experience developing analytical comparability protocols and reports.
- Strong organizational and project management skills.
- Strong oral and written communication skills.
- Ability to work independently with minimal supervision.
- Ability to effectively identify and communicate risks.
- Experience with deviation management and change control processes.
- Experience in effectively managing analytical development and testing activity at external vendors such as Contract Manufacturing Operation (CMOs).
Preferred Experience and Skills:
- Capital Management Committee (CMC) document preparation.
- Experience with LIMS systems.
- Experience with continuous improvement or lean six sigma methodology.
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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