Job Description

About the role

You will join our Large Molecule Analytical Validation team to serve as an Analytical Program Lead. The lead must take charge in overseeing and guiding analytical strategies, driving the technical execution of large molecule (biologics and vaccine) programs as they progress from development to commercialization as part of the Development and Commercialization Team. The incumbent should apply stage appropriate scientific rigor, ensure adherence to timelines across all workstreams, and proactively mitigate challenges that may arise. The lead will maintain program schedules diligently while escalating any identified risks to ensure smooth progress and successful outcomes. In this role, you will work closely with cross functional teams within Biologics and Vaccines AR&D, Global Quality, Upstream/Downstream Process Development, Formulations, Global Clinical Supply, CMC Regulatory, Quality, and Commercial-facing Partner Groups to support commercialization of our products.

Responsibilities:

• Working with external partners to manage, oversee, take ownership and accountability of all analytical deliverables, including method development, testing, validation, transfer, stability, extended characterization, and formulation workstreams.

• Serve as the primary point of contact for key stakeholders for all Analytical Research and Development (AR&D).

• Develop and implement the analytical strategies for large molecule (biologics and vaccines) programs in a matrix team environment to enable delivery on time.

• Provides multi-disciplinary leadership to the team and is able to foresee emerging issues, drive recommendations through to implementation with an enterprise mindset, and influence others in a matrix organization.

• Drive disciplined decisions in rapidly evolving, complex or ambiguous situations and effectively represent these decisions across functional areas and governances.

• Provides guidance and support to the team in troubleshooting analytical issues and resolving conflicts.

• Coordinate and facilitate the development, optimization, and validation lifecycle activities of analytical methods.

• Support Quality by Design (QbD) activities and lead discussions on process and analytical risk assessment.

• Proactively initiate technical reviews within AR&D and serve as the Analytical representative on governance interactions and stage-gate reviews.

• Develop and maintain a central repository for knowledge and life-cycle management of the program to support regulatory filings.

Required Experience and Skills:

• Extensive experience in analysis of biologics and vaccines encompassing all types of analytical methods.

• Strong background in analytical and integrated control strategy development and execution with a sound scientific understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications

• Experience in establishing phase appropriate specifications, justifying specifications as governance, and authoring source documents to support filings

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving

• Actively develops high performing teams

• Ability to design, execute and/or direct the development, validation and transfer of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development

• Proficient in the development of comparability strategies to enable agency acceptance

• Experience in the design of stability studies to maximize product shelf-life claim including combination products

Qualifications:

• Bachelor's degree in chemistry, Biochemistry, Engineering, Pharmaceuticals, or a related field with at least 14 years of relevant experience. Alternatively, a master's degree with 10 years of relevant experience or a Ph.D. with 8 years of relevant experience.

• Possess a deep technical expertise within analytical on biochemical, biophysical, and biological activity-based assays for large molecules with demonstrated ability to support new product development and commercialization.

• Understands connectivity between cross functional partners to support pipeline progression

• Strong knowledge of large molecule CMC requirements and experience in supporting health authority filings.

• Effective communication and leadership skills in a dynamic environment.

• Project management experience, including tracking, supporting, and communicating timely delivery of milestones.

• Ability to work independently and within cross-functional teams.

• Familiarity with current Good Manufacturing Practices (cGMP) and health authority submissions and interactions

Current Employees apply HERE

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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

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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.

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Requisition ID:R327817