Biologics and Vaccines Analytics (BVA), Our Manufacturing Division is responsible for the commercialization of large molecule (vaccines, biologics) analytical techniques from Phase III through launch and transfer to supply as well as in-line analytical support to enable world-wide robust vaccine and biologics availability. This team is highly motivated, fast-paced and focused on the rapid advancement of our company's large molecule pipeline, plus growth of existing products. This position will involve all stages of late stage development, validation, transfers and life-cycle management of methods supporting our company's large molecule pipeline and inline products.
- Oversee GMP lab areas and equipment to ensure a constant state of testing readiness.
- Participate in equipment and instrument installation, operation, and performance qualification.
- Complete investigations, change control and author SOPs as needed.
- Act as A Subject Matter Expert and perform training of the lab analysts.
- Support routine testing and housekeeping of the lab as needed.
- Complete appropriate documentation supporting testing procedures, including data capture forms, equipment logbooks and inventory forms.
- Maintain current training on all assigned procedures to include read & understood, skills development and classroom training activities as required.
- Maintain close communication and interaction with management and staff to ensure on-time completion of assigned activities
- Fully comply with company health and safety procedures and practices
- B.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 2+ years of relevant industry experience;
- M.S. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 2+ years of relevant industry experience;
- Ph.D. in biochemistry, molecular/cellular biology, or equivalent bio-related science with 1+ years of relevant industry experience.
Required Experience and Skills
- Experience working in a cGMP laboratory environment in the area of large molecules (vaccines, biologics).
- Experience with instrument qualification and maintenance.
- Experience with deviation management and change control processes.
- Experience with LIMS systems.
- Strong oral and written communication skills.
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.
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., Kenilworth, NJ, USA, also known as Merck Sharp & Dohme Corp., Kenilworth, NJ, USA, does not accept unsolicited assistance from search firms for employment opportunities. All CVs / resumes submitted by search firms to any employee at our company without a valid written search agreement in place for this position will be deemed the sole property of our company. No fee will be paid in the event a candidate is hired by our company as a result of an agency referral where no pre-existing agreement is in place. Where agency agreements are in place, introductions are position specific. Please, no phone calls or emails.
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