Job Description

Job Description

We are seeking a highly motivated individual to join our team providing technical ownership and support for bioanalytical methods. These methods include multiple assay platforms, including ELISA and Cell-based Assays and are used in testing Biologics products and late-stage pipeline candidates. The group will be responsible for the commercialization of assays supporting our late-stage pipeline as well as the technical oversight of analytical methods supporting our commercial products.

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.

Education Minimum Requirement:

* Bachelors degree in biology, chemistry, biochemistry or related science with 4 years of relevant experience in analytical development, validation, and/or quality control (QC)

* Master's degree in biology, chemistry, biochemistry or related science with 2 years of relevant experience in analytical development, validation, and/or quality control (QC)

* PhD in biology, chemistry, biochemistry or related science

Required Experience and Skills:

* Experience with bioassays, immunoassays and/or biologics research. Including such techniques as ELISA, Bioassays, Cell Culture, Cell Activation

* Experience with late stage method development, validation, transfer, and trouble-shooting

* Development and management of project timelines and deliverables

* Participation in cross-functional project teams

* Authoring and review of technical documents

* Ability to work independently and within a cross-functional team

* Ability to learn new techniques

* Good technical, communication (oral and written), interpersonal, and teamwork skills

* Self-motivated with a positive attitude and proven performance record

* 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.

* Strong organizational and project management skills.

* Ability to effectively identify and communicate risks.

* Experience with deviation management and change control processes.

Preferred Experience and Skills:

* Capital Management Committee (CMC) document preparation.

* Experience with LIMS systems.

* Experience with continuous improvement or lean six sigma methodology.

* 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.

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 thats committed 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 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.

MMDHJ

LI-PG1

BVA

US and Puerto Rico Residents Only:

If you need an accommodation for the application process please email us at staffingaadar@msd.com
For more information about personal rights under Equal Employment Opportunity, visit:

EEOC Poster

EEOC GINA Supplement

OFCCP EEO Supplement

OFCCP Pay Transparency Rule

We are an equal opportunity employer, Minority/Female/Disability/Veteran proudly embracing diversity in all of its manifestations.

Search Firm Representatives Please Read Carefully
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.

Employee Status:

Regular

Relocation:

Domestic

VISA Sponsorship:

No

Travel Requirements:

10%

Flexible Work Arrangements:

Not Specified

Shift:

1st - Day

Valid Driving License:

Hazardous Material(s):

General Laboratory Hazards

Number of Openings:

1
Requisition ID:R82632