Job Description

The Global Vaccines and Biologics Commercialization (GVBC) team within our Manufacturing Division is dedicated to the late-stage process development, technology transfer, and ongoing support of large molecule products, including vaccines and biologic therapeutics. Our mission is to ensure a compliant and cost-effective supply of our top-tier inventions to patients through technical excellence. We support manufacturing sites by commercializing our pipeline and offering technical assistance in the production, testing, and release of our products.

As a member of the Process Attribute Sciences team, you will join a dynamic and inclusive group of expert process scientists and engineers. In this role, you will serve as a PAS lead, playing a vital role in drug substance (DS), drug product (DP), and analytical working groups. You will be responsible for developing in-process testing strategies for both internal and external commercialization activities and will work closely with analytical subject matter experts (SME's) to ensure method readiness for technology transfer and late-stage/PPQ campaign support. Additionally, you will coordinate testing activities necessary to support small-scale process development, as well as late-stage process and product characterization activities. A strong technical background in analytical tools for characterizing process and product-related variants of large molecules is essential for this role.

You will have the opportunity to collaborate with GVBC teams and our Research Division partners to implement process analytical platforms that enhance manufacturing capabilities in our commercialization and in-line product manufacturing facilities. You will also be responsible for developing regulatory strategies to secure global acceptance of innovative control strategies that will be filed with our next-generation process and analytical platforms. Your contributions will include the development and implementation of advanced real-time technologies to support new product development and process control applications in manufacturing, ultimately helping our company achieve its 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 research and development to support process and product development in support of all activities (including small scale and large scale sample testing) required for process validation.

• Single point of contact to ensure successful execution of the in-process testing strategy on behalf of the DS, DP, and analytical working group leads.

• .

• Represent our companytduring regular interactions with external contract manufacturing partners to ensure scope of method establishment is completed on time.

• Drive process and product comparability studies in collaboration with process scientists and analytical SMEs that enable successful process performance qualification activities.

• Work with PAS colleagues to ensure in-process methods are established internally and that SME's are appropriately resourced to support program testing requirements.

• Mentor new PAS leads

• Drive quality by design (QbD) into process development by supporting the identification of critical quality attributes and understanding how to control these during fermentation and purification.

• Proactively communicate program technical risks to ensure best science at filing.

Education Guideline:

• B.S./M.S. in chemistry, biochemistry, analytical chemistry, biological engineering, chemical engineering, or a related discipline with 5+ years of relevant industry experience or a Ph.D. with 0+ years

Required Experience and Skills:

• Hands on experience in the operation and troubleshooting of analytical instrumentation including UPLC, HPLC, or CE.

• Technical proficiency with the mechanism behind chromatographic separations common to the biopharmaceutical industry

• Excellent oral and written communication skills to a diverse set of audiences.

• Ability to work independentlyin a multidisciplinary team environment

• Adaptive and self-motivated individual who can drive towards innovative solutions in occasionally ambiguous situations.

Preferred Experience and Skills:

• Familiarity with mammalian cell culture process and purification techniques for proteins.

• Demonstrated track record of delivering excellent results while working in a team environment.

• Familiarity with analytical techniques such as ELISA, PCR, Capillary Electrophoresis, and Mass Spectrometry are a plus.

• Ability to listen to stakeholders, understand their needs, and prioritize activities that drive towards agreed upon solutions.

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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.

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:

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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:

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:

Relocation:

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Requisition ID:R334719