Senior Scientist, Process Analytical Technology

Job Description

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 an individual 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 Global Small Molecule Science and Technology (SMS&T) organization within Manufacturing Division focuses on late-stage process development, technology transfer, implement control and rapid release strategy and in-line support of small molecule drug substance and drug products. Our mission is to enable current and future compliant supply of our finest inventions to patients at a competitive cost through technical excellence. This position is located in Rahway, New Jersey.

As a member of SMS&T, you will serve as a Senior Scientist driving solutions for the rapid characterization and process understanding of small molecule drug substance and drug products. This is a laboratory-based role where you will join a diverse team in a center of excellence supporting product commercialization and product release with process analytical technology for small molecule drug product processes.

As a member of the Process Analytical Technology team (PAT), you will integrate with a motivated and inclusive team of expert scientists and engineers passionate about PAT tools application from process development, routine manufacturing and product release. The Senior Scientist will be responsible for development, optimization and implementation of new in-line, on-line and at-line analytical technology to support small molecule drug substance and drug product process understanding throughout the full product life cycle. The candidate will have a strong technical background in spectroscopy (Raman, FTIR, NIR, UV, Fluorescence), multivariate (chemometrics) modelling skills and process control for pharmaceutical drug product processing and hands-on-experience and in-depth understanding of PAT concepts and its application to Pharmaceutical development.

Your expertise will be applied to both traditional batch as well continuous manufacturing processes for diverse modalities in our small molecule pipeline and commercial product portfolio.

You will have the opportunity to collaborate within SMS&T groups as well as our Research Division partners to realize the implementation of process analytical technology platforms enabling highly capable manufacturing in our commercialization and in-line product manufacturing facilities. The incumbent will also be responsible for developing regulatory strategies to ensure the world-wide acceptance of innovative control and product release strategies to be filed with our company's next generation process and analytical platforms. The scope of the contributions includes development and implementation of advanced real-time technologies to support development of new products as well as methods for process control and product release applications in manufacturing to ultimately help meet our World Class Supply objectives of highest quality, lowest cost, and shortest lead time.

Job role expectations:

• Partner with scientists and engineers in upstream drug product development and operations areas to identify opportunities and optimize the use of process analytical technology methods to support process and product development in the commercialization lifecycle phase.
• Develop and validate in-line, on-line or at-line PAT methods to monitor and control process parameters or product quality attributes to support process understanding, product development studies, and comparability assessments.
• Develop and validate at-line or laboratory PAT methods for small molecule drug product release.
• Apply chemometrics and multivariate data analysis techniques for PAT calibration and spectral data interpretation in alignment with process data.
• Support PAT scale-up and technology transfer to large scale manufacturing.
• Develop standard process analytics platforms encompassing all available tools to enable deep process understanding. These include, but are not limited to, in-line/on-line spectroscopic based methods (FTIR, Raman, NIR, UV, Fluorescence etc.) and support other tools such as FBRM, on-line HPLC, in-line particle characterization and on-line MS.
• Write technical protocols and reports ensuring compliance with applicable regulatory guidelines.
• Support scientific documentation, validation of PAT methods and contribute to regulatory filling sections regarding PAT methods.
• Interface with global regulatory agencies to ensure successful regulatory filings regarding PAT methods for process control and/or release.

Education Guideline:

• B.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with 5+ years of relevant industry experience
• M.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with 3+ years of relevant industry experience or a
• Ph.D. with 0 year's
• A record of relevant publications

Required Experience and Skills:

• Demonstrated capability in development and validation of Process Analytical Technologies
• Technical proficiency in operation and troubleshooting of Spectroscopic instrumentation including Vibrational Spectroscopy (Raman, FTIR, NIR, etc.),
• Spectra interpretation, and analysis
• Data-driven qualitative and quantitative chemometric model building approaches

Preferred Experience and Skills:

• Fast learner, self-motivated to drive innovation with a problem solving mindset;
• Expertise with innovative process analytical technologies for small molecule drug products
• Strong data analysis skills including a knowledge of multivariate statistics
• Hands-on experience with analytical spectroscopy (NIR, FTIR, or Raman, UV, Fluorescence)
• Excellent communication skills. Must be able to communicate technical information both verbally and written in a concise manner;
• Ability to work independently in a multidisciplinary and team environment.
• Must be able to work effectively in a cross-functional team environment.
• Hands-on experience using multivariate software platforms such MATLAB, SIMCA, Unscrambler for data analysis.
• Experience with PAT Manufacturing systems automation (SIPAT, Modbus, OPC, PLC)

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.

Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.

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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.

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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.

Under New York City, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.

Expected salary range:
$107,600.00 - $169,400.00

Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. For Washington State Jobs, a summary of benefits is listed here.

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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:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Flex Time

Shift:
1st - Day

Valid Driving License:

Hazardous Material(s):

Requisition ID:R250221