Associate Principal Scientist (Hybrid) | Alabaster, AL

global method ownership, and many other cross functional interactions. This position is technical in nature and demonstrated expertise in viral vaccine analytics is required. The role also requires effective collaboration with external contract providers as well as colleagues in our research laboratories, supply chain, site and global Quality, as well as CMC-Regulatory.

Responsibilities include but are not limited to: Direct an analytical working group for commercial vaccine program(s). Collaborate across the internal network, external partners, international governments and/or contract manufacturing and research organizations (CMO/CRO) in large molecule (biologics) analytics Coordinate

with analytical and process development groups to prepare for and coordinate analytical troubleshooting, validation and technology transfers between our Company, external partners and CMO/CROs Guide cross-functional teams and ensure alignment with analytical strategies and Quality Systems in support of analytical procedure Lifecyle management.

Steer teams of subject matter experts to develop and optimize existing analytical methods to enable modernization of our testing strategies. Accountability for analytical method transfers and in-line assay method validations, including review of protocols and reports. Routine assay monitoring and trending to ensure a robust analytical testing network.

Develop, maintain and execute the strategy for global analytical methods including routine evaluation of methods for analytical lifecycle changes.

Escalation of key project challenges to management in a timely and concise manner. Partnership with critical reagent and reference standard groups to ensure unconstrained supply of reagents required for routine analytical testing. Perform technical review of analytical change requests, atypical analytical results, Out-Of-Specification results, and analytical methods. Coordinate analytical issue resolution via subject matter experts within the global large molecule network. Minimum Education Requirement and Experience: Bachelor's Degree (BA/BS) with a concentration in sciences with eight (8) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Master's Degree (MA/MS) with a concentration in sciences with six (6) years of experience working in the field of analytical testing, development, transfer, and/or validation; OR Ph D with a concentration in sciences with three (3) years of experience working in the field of analytical testing, development, transfer, and/or validation.

Required Experience and Skills: Demonstrated experience with analytics for commercial viral vaccine products Effective communication and teamwork.

Experience with large molecule GMP testing including drug substance and drug product stability and release testing. Experience with analytical comparability Experience leading a cross-functional team Strong technical expertise in general large molecule analytical laboratory operations, equipment, and techniques Preferred Experience and Skills: Continuous improvement or Project Management training Writing or review of regulatory filings (IND, MAA, BLA, PAS, CBE) and inspections with multiple agencies (FDA, EMA, JNDA) Experience with large molecule analytical transfers Experience with commercial product analytical method changes Experience with assay monitoring and trending 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.

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, interaction, interactionual 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, 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" 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 Requisition ID: R259382PDN-9a22cb5d-e4bd-46cb-8b1f-ebea5b872cf3