Associate Principal Scientist (ADC), Sterile Drug Product Commercialization - Military Veterans

Job Description

About Us:

The Discovery, Preclinical and Translational Medicine Operations (DPTM) is seeking an Associate Director to lead the Molecular lab within the Late Development (AdVAnce) Vaccines bioanalytical group located at our Company's new state-of-the-art AdVAnce GxP research facility in West Point, PA. At this new facility, we will combine the power of innovative robotics, IT platforms, and science to accelerate vaccines and enable late-stage clinical trials through the generation of timely, high-quality regulated bioanalytical data. A combination of molecular (e.g., PCR), serology (e.g., ligand binding titer immunoassays), and cell-based assays (e.g., neutralizing assays) will be utilized to generate pivotal safety and efficacy clinical patient data required for regulatory filings. As the AdVAnce facility will not be fully constructed and ready for occupancy until 2026, initial roles will complete training and perform work primarily at our Company's Springhouse Innovation Park facility in Lower Gwynedd Township, PA.

We are seeking a talented, organized, and innovative leader to lead our Laboratory Operations and System Validation team. The successful candidate will coach and mentor staff, oversee the end-to-end lifecycle of regulated laboratory equipment (from onboarding and maintenance to retirement), and manage and improve the computer system validation of laboratory equipment. This individual should be collaborative and capable of developing a network of vendors, QA, IT, and other collaborators to support equipment within an expanding laboratory, balancing ongoing pipeline support while innovating processes.

Position Location :

• West Point, Pennsylvania (with ~25% travel to Spring House, PA)

Responsibilities :

• Lead a team of staff that span across Laboratory Operations and provide supervision, mentorship, and coaching.
• Work closely with divisional/enterprise IT teams, global infrastructure, and risk/security organizations to ensure that project deliverables and ongoing operations receive appropriate support.
• Support the successful implementation of automation solutions, including both platform technologies and associated reporting needs.
• Assist in developing a suite of reporting, analytics, and visualization solutions that support local operations and administrative business processes.
• Ensure automation systems are maintained in a validated state, as part of an active/ongoing lifecycle management program and in compliance with current GXP requirements
• Use technical knowledge to assure the efficient operation of a variety of automated processing and operational and informational technology systems.
• Apply deep expertise in the computer system validation process of lab equipment, including the conduct of system validation for diverse lab equipment (e.g., plate readers, lab automation, liquid handlers).
• Oversee asset management activities across a variety of vendors, service engineers, and facilities staff while building and maintaining strong working relationships.
• Serve as a system administrator of equipment applications, temperature monitoring systems, and assist in managing controlled temperature units and alarm handling.
• Partner with vendors, QA, and IT to develop best practices for maintenance requirements and computer system validation processes. Maintain a motivated mindset toward continuous improvement.
• Utilize electronic application platforms (Electronic Notebooks, Procal, Benchling, etc.) to input and retain calibration documentation; participate in efforts to upgrade or replace related applications.
• Represent the DPTM Laboratory Operations on all aspects of laboratory equipment and system validation during audits.
• Operate within the confines of departmental Standard Operating Procedures (SOP) and regulatory guidance; responsible for authorship of equipment-related SOPs and job aids.

Education Minimum Requirement:

• B.S. Degree in Biology, Chemistry, Engineering, or related sciences with at least 8 years of industry experience

Required Experience and Skills:

• Demonstrates strong interpersonal skills with the ability to influence and support others through a culture of inclusion, feedback, and empowerment.
• Strong project management skills, with the ability to plan, execute, and monitor projects to successful completion.
• Follows Standard Operating Procedures with insight for continuous improvement.
• Direct support of validation activities and all other associated Quality functions
• Understands and applies regulatory/compliance requirements relative to their role.
• Experience working within a GxP laboratory, preferably in an analytical lab.
• Experience with supervision/management of staff in a direct reporting relationship.
• Highly organized, and capable of multitasking to manage a variety of equipment or system-related schedules, documents, and maintenance tasks.
• Applies general knowledge of company business developed through education or experience.
• Excellent written and verbal communication skills, with the ability to articulate complex technical information to non-technical stakeholders.
• Ability to work independently and as part of a multidisciplinary team in a challenging environment.
• An analytical person/troubleshooter, skilled in Root Cause Analysis (RCA).

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, 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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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.

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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

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:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:
Not Applicable

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:
01/31/2025
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