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Job Description

Principal Scientist, Late Stage Analytical Program Lead

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

Preferred Qualifications:

• Prior experience managing therapeutic product analytical programs

• Previous experience leading or working in a quality control or analytical development organization

• Familiarity with typical analytical techniques used for large molecule batch release and stability testing

• Experience using project management, validation and EDMS solutions (e.g. scheduling tools, PowerBI, Kneat, Trackwise

#AR&D

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 separationpackage, 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.

Current Employees apply HERE (https://wd5.myworkday.com/msd/d/task/1422$6687.htmld)

Current Contingent Workers apply HERE (https://wd5.myworkday.com/msd/d/task/1422$4020.htmld)

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 (https://survey.sogosurvey.com/r/aCdfqL) 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 (https://www.eeoc.gov/sites/default/files/2022-10/22-088_EEOC_KnowYourRights_10_20.pdf)

EEOC GINA Supplement​

Pay Transparency Nondiscrimination (https://www.dol.gov/sites/dolgov/files/OFCCP/pdf/pay-transp_%20English_formattedESQA508c.pdf)

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 (https://www.msdprivacy.com/us/en/CCPA-notice/)

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, generally Tuesday, Wednesday and either Monday or 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:

$149,400.00 - $235,100.00

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 (https://www.benefitsatmerck.com/) .

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:

Not Indicated

Valid Driving License:

No

Hazardous Material(s):

n/a

Job Posting End Date:

09/17/2024

*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.

Job Posting End Date: 09/17/2024

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: R306127