Senior Principal Scientist, Clinical Research, GYN malignancies - Military Veterans

Job Description

Position Description:

Under the Site Quality Head's direction, the QC Lab Manager oversees guidance and supervision for QC Specialists and Technicians to fulfill testing and support activities.

The role encompasses responsibility for Animal biologics, including animal safety/potency testing and other logistics, bacteriology/sterility testing, team development for seasoned QC analysts, maintaining a comprehensive training program, and fostering a compliant and safe culture through policy implementation. This dynamic position operates within a fast-paced setting and involves managing 10-15 direct reports.

Additional Responsibilities:

• Oversee the QC team, providing management, coaching, and mentorship to cultivate technical expertise. Foster a diverse talent pool equipped for success and encourage collaboration, teamwork, and transparent communication.
• Conduct testing of final and bulk products, raw materials, and demonstrate proficiency in the analytical techniques relevant to the supported laboratories.
• Handle Animal biologics, encompassing potency, safety testing and animal care, as well as study director for IACUC, and other related projects.
• Author, review, revise, and approve SOPs, Quality Control Procedures, and other critical business documents.
• Supervise the QC training program to guarantee employee competency and qualification for their roles.
• Evaluate data critically for product release, advising on acceptance or rejection.
• Maintain records, devise improvement strategies, and manage tracking functions like corrective actions and special projects.
• Lead or assist in Investigations, Root Cause Analysis, CAPA implementation, and effectiveness assessments.
• Lead or aid in the effective Change Control of processes and documentation.
• Investigate safety and environmental incidents, modeling a safe and compliant culture in the laboratories.
• Support internal audits and regulatory lab inspections, acting as a subject matter expert.
• Serve as a resource and intermediary between technicians and support groups to ensure seamless operations.

Education Minimum Requirement:

• Bachelor's degree in biology, Microbiology, Virology, Biochemistry, or related field

Required Experience and Skills

• Minimum five (5) years of laboratory, manufacturing, or quality experience in a cGMP environment.
• Working knowledge in the biotech industry with specific understanding of QC operations, regulatory agency engagement and ability to gain alignment on strategy.
• Demonstrated principled verbal and written communications.
• Servant Leadership Mindset
• Excellent interpersonal communication skills
• Demonstrated ability or aptitude for continuous learning and analytical problem solving with experience in root cause analysis and CAPA deployment.
• Animal care and biologics testing experience

Preferred Experience and Skills

• Experience developing and improving methods for biological and/or biochemical assays.
• Continuous Improvement and Lean methodology experience.
• Strong knowledge of USDA, GMP, regulation regarding vaccine manufacture
• Assay validation methods and report writing

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.

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:

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, 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:
Domestic

VISA Sponsorship:
No

Travel Requirements:
10%

Flexible Work Arrangements:
Not Applicable

Shift:
1st - Day

Valid Driving License:
No

Hazardous Material(s):
n/a

Job Posting End Date:
12/2/2024
*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.