Job Description
Specialist, Biologics External Manufacturing Operations (Cell Banking Support)
P2
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 Organization (formerly called BioExM Cell Banking End to End Team) is looking for a 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:
- Supporting operations owned change controls Supporting partner, site and team interactions
- Managing transactions within SAP
- Supporting 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 three (3) years’ experience in Pharma Operations or Master’s degree level with one (1) years’ experience in Pharma or Pharma Cell Banking Operations.
Required Experience And Skills
- Must possess excellent interpersonal, communication, collaboration, negotiation, and project management skills.
- Project Management skills are very important for this role.
- 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
Current Contingent Workers apply HERE
US And Puerto Rico Residents Only
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Requirements
As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. 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 together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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:
No relocation
VISA Sponsorship
No
Travel Requirements
10%
Flexible Work Arrangements
Hybrid
Shift
1st - Day
Valid Driving License
No
Hazardous Material(s)
n/a
Required Skills
Adaptability, Adaptability, Asset Management Systems, Biological Manufacturing, Biotechnology Manufacturing, Business, Business Processes, Communication, Contract Management, External Manufacturing, Good Manufacturing Practices (GMP), Human Resource Management, Management Process, Manufacturing Operations, Marketing Resource Management (MRM), Meeting Facilitation, Operations Management, Production Quality, Production Scheduling, Product Lifecycle, Product Management, Project Human Resource Management, Project Management, Project Manufacturing, Quality Assurance Compliance {+ 4 more}
Preferred Skills
Job Posting End Date:
06/1/2025
- 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:R351970
