Job Description

We are seeking a growth and improvement-minded Associate Principal Scientist that can help drive our Strategic Operating Priorities.

Associate Principal Scientist: Container Closure Integrity Testing (CCIT)

Global Quality Large Molecule Analytical Sciences (GQLMAS) in West Point PA, in our Manufacturing Division, is accountable for the inline analytical support of large molecule programs including vaccines and biologics. This team is highly motivated, fast-paced and focused on the rapid advancement of our Company's large molecule pipeline, plus growth of existing products. We also provide in-line analytical sponsorship to enable world-wide robust vaccine and biologics product availability.

We are seeking a talented and self-motivated Associate Principal Scientist with proven experience overseeing container-closure system integrity testing (CCIT), in order to establish a CCIT troubleshooting laboratory for large molecule (biologics and vaccines) product images (vial, syringe, delivery device, bulk/flexible/rigid containers); provide subject matter expertise for CCIT method transfer, validation and technical support during container-closure integrity testing by internal and external sites, be familiar with current industry and regulatory thought on CCI, and identify as a subject matter expert to assist our Manufacturing Division partner functions in a technical consulting role regarding CCIT and container-closure system attribute testing.

This position will involve method troubleshooting, analytical tech transfer, and analytical procedure lifecycle (APLC) management with a focus on Container Closure Integrity testing (CCIT) and compendial methods. The successful candidate will interface with our QC partners across our Company network and external partners to provide SME support where needed.

Education Minimum Requirement:

• Ph.D. degree with 2 years relevant working experience

• Master degree with 4 years relevant working experience

• Bachelor degree with 6 years relevant working experience

Required Experience and Skills:

• Hands-on experience in CCIT testing and troubleshooting for injectable therapeutics. Candidate should be familiar with following CCIT technologies for this purpose: dye ingress, high voltage leak detection, vacuum and pressure decay, laser headspace analysis

• Experience in day-to-day management of laboratory analysts performing CCIT method development, validation, release and stability testing

• Strong knowledge of current global regulatory thought related to all aspects of CCIT

• Excellent organizational skills to manage multiple projects

• Good written and oral communication skills

• Ability to work and lead in a collaborative multidisciplinary working environment.

Preferred Experience and Skills:

• Experience in biologic and/or vaccine drug product manufacturing, process development, inspection and release testing

• Training and proficiency in current good manufacturing practices

• Successful track record of management of a biologics or vaccines quality control or analytical development laboratory

• Experience in authoring of regulatory documentation and health authority interactions representing analytical function

• Prior experience in analytical technology transfer and day to day management and oversight of contract testing organizations performing release, stability or characterization testing of biologic or vaccine products

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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".

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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Relocation:

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Requisition ID:R332062