The Molecular & Viral Safety group within Cell Based Sciences (Analytical R&D) is seeking applicants for a Senior Scientist position located at our West Point, PA research facility. The successful candidate will contribute to delivering analytical solutions that enable and accelerate process and product development to ensure safety and quality of our products. Key deliverables will include method development, implementation, and scientific oversight of viral and biosafety testing for cell substrates and virus stocks used for GMP manufacturing .
The successful candidate will be able to collaborate in a dynamic, integrated, and multidisciplinary team environment. An expansive range of analytical tools (e.g. microbiology, molecular biology, Sanger and next generation sequencing, etc.) are leveraged and new technologies are developed to ensure that our vaccine and biologic products are free of adventitious agents.
Responsibilities include:
Design adventitious agent detection analytical control strategies and develop custom analytical methods used for release and characterization of cell substrates and virus stocks for GMP manufacture of vaccines and other biological products.
Provide technical review and/or approval of biosafety related methods, reports, and data in alignment with current regulatory requirements.
Author technical reports and sections of regulatory filing documents.
Build and maintain deep technical expertise in area of biosafety and adventitious virus testing.
Contribute to solving complex problems and technical advances in the field.
Represent the molecular & viral safety group on cross-functional project teams.
Demonstrate effective multitasking, prioritization and problem-solving skills in the planning and execution of experiments
Effectively collaborate in a fast-paced, integrated, multidisciplinary team environment
Education Minimum Requirement:
A Ph.D.; or a master's degree with a minimum of 5 years' experience; or bachelor's degree with a minimum of 8 years' experience in virology, microbiology, microbiology, molecular biology, biological sciences, or related discipline in the biopharmaceutical industry.
Required Experience and Skills:
Strong background and direct experience in applying a variety of virology, molecular biology, and microbiology techniques to understand and solve diverse scientific questions.
Familiar with Sanger sequencing, next generation sequencing, and modern PCR methods.
Strong skills in data and sequence analysis.
Demonstrated scientific ability through publications in peer reviewed journals and presentations in scientific conferences.
Excellent verbal and written communication skills, demonstrated creativity, and strong interpersonal skills.
Ability to deliver complex objectives under strict timelines in a rapidly changing environment
Ability to work in a diverse, cross-functional team environment.
Preferred Experience and Skills:
Working knowledge of regulatory and industry guidelines in the area of biosafety testing, including compendial requirements, CFR and ICH requirements, and WHO/EMA/FDA regulations.
Familiarity with electronic laboratory notebook applications and good documentation practices
Prior work in a biopharmaceutical industry and knowledge of cGMP practices
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., Rahway, 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 ...
Imagine getting up in the morning for a job as important as helping to save and improve lives around the world. Here, you have that opportunity. You can put your empathy, creativity, digital mastery, or scientific genius to work in collaboration with a diverse group of colleagues who pursue and bring hope to countless people who are battling some of the most challenging diseases of our time. Our team is constantly evolving, so if you are among the intellectually curious, join us-and start making your impact today.
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.
Residents of Colorado
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For positions located in the United States and Puerto Rico - Subject to applicable law, all new hires (including internal transfers) must demonstrate that they are fully vaccinated against COVID-19 or that they qualify for a medical or religious exemption to this vaccination requirement. New hires (including internal transfers) to a position that, as determined by the Company, requires routine collaboration with external stakeholders (such as roles in health services or customer-facing commercial or research-based roles) ("Customer-Facing Role") who are not vaccinated must qualify for a medical or religious exemption and be in a position that the Company determines can accommodate unvaccinated employees without causing an undue burden to business operations. If, following dialog with the candidate as appropriate, it is determined that the candidate either a) does not qualify for a religious or medical exemption or, b) for candidates applying for Customer-Facing roles, it is determined that allowing the candidate to work without vaccination would cause an undue burden to the Company, the candidate will be ineligible for hire or transfer, or any offer of employment or transfer (if applicable) will be revoked. Please note that notwithstanding the approval of any reasonable accommodation, the Company reserves the right to monitor, modify, or revoke any such accommodation if it is determined, following dialog with the employee, that the accommodation is no longer effective or results in an undue burden to the Company.
Current Employees apply HERE
Current Contingent Workers apply HERE
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 click here if you need an accommodation during the application or hiring process.
For more information about personal rights under Equal Employment Opportunity, visit:
EEOC Know Your Rights
EEOC GINA Supplement
Pay Transparency Nondiscrimination
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.
Residents of Colorado:
Click here to request this role's pay range.
Learn more about your rights, including under California, Colorado and other US State Acts
Search Firm Representatives Please Read Carefully Merck & Co., Inc., Rahway, NJ, USA, also known as Merck Sharp & Dohme LLC, Rahway, 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: Yes
Travel Requirements:
Flexible Work Arrangements:
Shift:
Valid Driving License:
Hazardous Material(s):
Number of Openings: 1
To apply please click on APPLY TO THIS POSITION
Job Post Date: 01/22/23
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