You will have the opportunity to collaborate with GVBC groups as well as our Research Division partners to realize the implementation of process analytical 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 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 applications in manufacturing to help meet the World Class Supply objectives of highest quality, lowest cost, and shortest lead time.

Job role expectations:

• Partner with scientists in upstream cell culture/fermentation, purification, and drug product 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.
• Apply chemometrics and multivariate data analysis techniques for PAT calibration and spectral data interpretation in alignment with process data.
• Lead the systematic assessment and deployment of PAT tools/testing and enable enhanced process control strategies.
• 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, biophysical/separations assays, in-line/on-line spectroscopic based methods (FTIR, Raman, NIR) and support other tools such as FBRM, on-line HPLC, in-line particle characterization, on-line MS.
• Develop integrated control strategies based on these analytical platforms that will enable highly capable manufacturing processes across a range of modalities (live virus and conjugate vaccines, mAb' s, antibody-drug conjugates, and fusion proteins).
• 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./M.S. in chemistry, biochemistry, biotechnology bioengineering, chemical engineering, or a related discipline with 5+ years of relevant industry experience or a Ph.D. with 0+ years

Required Experience and Skills:

• Technical proficiency in the operation and troubleshooting of analytical instrumentation including vibrational spectroscopy (Raman, FTIR, NIR),
• Understanding of spectra interpretation, and analysis, with demonstrated capability in development of Process Analytical Technologies.
• Good knowledge of data-driven qualitative and quantitative chemometric model building approaches
• 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.
• Adaptive person, self-motivated to drive innovation with a problem-solving mindset.

Preferred Experience and Skills:

• Expertise with innovative process analytical technologies for vaccine and biologics
• Direct experience using multivariate software platforms such as PLS Toolbox, SIMCA, Unscrambler for data analysis.

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.

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.

We are an Equal Opportunity Employer, committed to fostering an inclusive and diverse workplace. All qualified applicants will receive consideration for employment without regard to race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or other applicable legally protected characteristics. For more information about personal rights under the U.S. Equal Opportunity Employment laws, 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.

Learn more about your rights, including under California, Colorado and other US State Acts

U.S. Hybrid Work Model

Effective September 5, 2023, employees in office-based positions in the U.S. will be working a Hybrid work consisting of three total days on-site per week, Monday - Thursday, although the specific days may vary by site or organization, with Friday designated as a remote-working day, unless business critical tasks require an on-site presence.This Hybrid work model does not apply to, and daily in-person attendance is required for, field-based positions; facility-based, manufacturing-based, or research-based positions where the work to be performed is located at a Company site; positions covered by a collective-bargaining agreement (unless the agreement provides for hybrid work); or any other position for which the Company has determined the job requirements cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".

The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. 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 US salary range:
$111,400.00 - $175,300.00

Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles' Fair Chance Initiative for Hiring Ordinance

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:
Hybrid

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
10/23/2024
*A job posting is effective until 11:59:59PM on the day BEFORE the listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R316088