Sr. Spclst, Biologics Operations Cell Banking Support
Merck
**Job Description**
Our Manufacturing Operations teams are the people that make our products. We work with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in our global manufacturing network (external & internal network) to ensure the highest quality of raw materials, intermediates, and finished products.
Our ability to excel depends on the integrity, knowledge, imagination, skill, diversity, and teamwork of an individual like you. To this end, we strive to create an environment of mutual respect, encouragement, and teamwork. As part of our global team, you’ll have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.
The GBO Biologics External Manufacturing End to End Cell Banking Team (formerly called BioExM Cell Banking Focus Factory) is looking for a Senior Specialist, Biologics External Manufacturing Operations to support the Cell Bank Global End to End Management Team. The Cell Bank Team is responsible for the manufacture, testing, shipping, and storage of cell banks needed to supply drug substance production sites within the GBO network (Internal GBO and External (CMO) GBO sites).
The Cell Banking End to End Team Support provides support in the areas of:
+ Understanding of operational aspects of biological cell bank manufacturing
+ Project management and oversight capabilities
+ Knowledge of SAP and Quality systems
+ Lean Six Sigma methodology
+ Strong communication and collaboration skills
+ Dispute resolution (w/ appropriate escalation)
+ Production Planning
+ Materials Management
+ Quality issues (Deviation Management, Product Release, Change Control)
+ Technology issues (Technology transfers, Investigations, Process Improvements, etc.)
+ Operational Excellence and Continuous Improvement activities
+ Metrics driven operations
+ Collaboration with internal and external partners as Cell Banking straddles both
The responsibilities of the Cell Bank End to End Team support include, but are not limited to:
+ Leading operations owned change controls and supporting cell bank change controls
+ Supporting partner, site and team interactions
+ Managing transactions within SAP
+ Managing storage, shipping & logistics activities for cell banks
+ Track operations performance metrics
+ Project Management activities
+ Material management activities
+ Supporting Cell Bank Supply Chain Working Group & Cell Bank (Technical) Working Group
+ Support continuous improvement initiatives within the End-to-End Team and with our partners at our internal Cell Bank Manufacturing sites and our External Cell Bank CMO Partners.
+ Collaborate with other Biologics External Manufacturing Operations Support personnel to leverage best practices & lessons learned across Biologics External Manufacturing Ops.
**Minimum Education Requirement and Experience:**
+ Bachelor’s degree in Engineering, Science or Business or related fields with five (5) years’ experience in Pharma Operations
**Required Experience and Skills:**
+ Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills.
+ Demonstrated problem solving, and sensitivity to diverse cultures.
+ Must possess the ability to work independently with minimal coaching.
+ Some cell banking (manufacturing or testing or control) experience is preferred but not essential.
The Cell Banking End to End Team Support with work with the Cell Banking Leads (team & org) to ensure the end-to-end functioning of the Cell Bank area and will also be a back-up to the Cell Bank Lead as required.
The Cell Bank End to End Team Support stays abreast with industry and policy changes and identifies implications and opportunities for his/her area of Biologics External Manufacturing and/or Internal Cell Banking Manufacturing Organization in support of Global Biologics.
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, 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:**
No relocation
**VISA Sponsorship:**
No
**Travel Requirements:**
10%
**Flexible Work Arrangements:**
Hybrid
**Shift:**
1st - Day
**Valid Driving License:**
No
**Hazardous Material(s):**
N/A
**Job Posting End Date:**
03/5/2025
***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:** R336049
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