Our company is a global health care leader with a diversified portfolio of prescription medicines, vaccines and animal health products. Today, we are building a new kind of healthcare company – one that is ready to help create a healthier future for all of us.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of people like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The Department of Pharmacokinetics, Pharmacodynamics and Drug Metabolism (PPDM) is seeking an experienced director to join the Regulated Immunogenicity and Molecular Biology Bioanalytics (BA) team. The primary role of the successful candidate will be to set the strategic direction and implement automation in workflows for vaccine program clinical assays. The position is accountable for delivering automated phase-appropriate, robust analytical clinical methods that adhere to the highest scientific standards. The desired candidate must also show strong working knowledge of implementing regulated (preclinical and clinical) assays and have experience in supporting regulatory submissions and responses (BLA submission). In this role, responsibilities include scientifically coaching and mentoring across the organization, being influential in program strategy cross-functionally across our company's portfolio, working across industry teams and with health authorities to develop immunogenicity assay guidance. The incumbent will be responsible for the recruiting and development of talent under her/his supervision.
The successful candidate will strategically influence general and program-specific assay development with a line of sight to successful product approvals via implementing robotic solutions. The director must be able to collaborate in a fast-paced, integrated, multidisciplinary team environment. Research and industry experience should demonstrate successful application and management of state-of-the-art automation, including experience with a variety of analytical automation platforms, sound scientific understanding of QbD/DOE principles as well as data analysis and statistics for reporting clinical data. Candidates without all qualifications will be reviewed and could be successful based on past achievements and a desire for continued learning.
Education Minimum Requirement:
A Ph.D. degree in Biology, Chemistry, Biochemistry, Bio-Engineering, Immunology, Virology, Pharmaceutical Sciences, or related area with 12+ years, a MS degree with 15+ years, or BS degree with 16+ years of relevant experience and sustained documented interactions with regulatory agencies.
Required Experience and Skills**:
Expertise in implementing and transferring robotic innovative solutions in a regulated environment
Strong scientific and technical expertise in regulated assay design, automation, development, transfer, and execution in support of GLP and clinical development programs
Independent manager with ability to hire, mentor, and inspire scientists at various levels; Encourages curiosity in others and challenges the status quo to foster innovation, well-developed decision-making skills that thinks broadly across development programs
Proven ability to lead development of new, innovative approaches including experience with new assay technology evaluation and shaping scientific strategy both at the platform and program level
Excellent oral and written communication skills
Experience leading diverse teams and driving a collaborative and inclusive mindset
Provide scientific oversight for robotic platforms assays being implemented at CROs, including review of trending data and technical reports. Some travel to CROs required.
Preferred Experience and Skills:
Serve as a program representative on development teams that collaborates with various late development program leaders across our company.
Background in biostatistics, and/or information management systems is desirable
Working knowledge of AI coding using machine learning algorithms and deep learning neural networks to assist with robotic solutions
Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or leading) cross-company working groups or consortia
We are a research-driven biopharmaceutical company. Our mission is built on the simple premise that if we “follow the science” that great medicines can make a significant impact to our world. We believe that a research-driven enterprise dedicated to world-class science can succeed by inventing medicine and vaccine innovations that make a difference for patients across the globe.
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.
NOTICE FOR INTERNAL APPLICANTS
In accordance with [Register to View] 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.
Current Employees apply [Register to View]
Current Contingent Workers apply [Register to View]
US and Puerto Rico Residents Only:
Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their true capabilities. Please [Register to View] if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
We are proud to be a company that embraces the value of bringing diverse, talented, and committed people together. The fastest way to breakthrough innovation is when diverse ideas come together in an inclusive environment. We encourage our colleagues to respectfully challenge one another’s thinking and approach problems collectively. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.
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.
Flexible Work Arrangements:
Valid Driving License:
Number of Openings:1