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Job Description
The Manufacturing Operations Associate Specialist is assigned to a product manufacturing team and partners with the Operations Managers in coordinating maintenance activities and ensure the manufacturing area is operating at peak efficiency.
Summary, Focus and Purpose
Qualified individuals will take responsibility for routine assay execution, laboratory maintenance, maintaining and reviewing GMP documentation, and proactive process and assay monitoring of the Varicella zoster virus propagation process. Conduct real-time flow cytometry assay in support of increased manufacturing process control and consistency in viral growth kinetics and contribute to maintaining a consistent community of practice amongst all lab analysts.
Key Functions
Support routine laboratory operations, including cleaning, supply ordering, and preventative maintenance
Support proactive process monitoring through assay and process data collection, GMP laboratory experiments (e.g., viral growth curves), etc.
Characterize existing processes, identify key sources of variability, and identify potential process improvements
A successful candidate must have problem-solving and troubleshooting skills, good attention to detail, and an interest in understanding how cell expansion and viral propagation impact the manufacturing process. Furthermore, the candidate must be able to work efficiently in a high paced environment, collaborate well with others, and have excellent interpersonal skills.
Minimum Required Education:
High School Diploma/GED with two (2) years of relevant experience in manufacturing or military service
Or:
Bachelor’s degree or higher, preferably in Science, (e.g., biology, microbiology, immunology, etc.), or engineering (e.g., biomedical, chemical)
Required Experience and Skills:
Demonstrated experience in data analysis/interpretation, and the ability to exercise scientific judgment and for real-time decision-making
Work both independently and within multi-functional teams in a fast-paced environment | Ability to work with little supervision and manage/differentiate ambiguous situations is important
Communication and documentation skills, including result reporting skills (i.e. presentation of results, impact, and recommendations)
Ability to work with others
Continue to progress towards achieving qualification on assays by completing training on required skills
Contingent upon demonstration of a positive titer against the virus
Work a flexible, rotating shift schedule, which will be predominantly night and weekend coverage will be required based on manufacturing process support needs
Preferred Experience and Skills:
Experience with flow cytometry (clinical flow cytometry is a plus) and/or performing immunoassays is preferred. Experience in analytical testing utilizing a variety of biochemical, molecular, and cell biology techniques
Experience in laboratory operations including scheduling, equipment maintenance, and GMP documentation
Experience with cell culture
Good general industrial process knowledge and experience with cGMP manufacturing and/or large-scale production
Schedule:
3rd Shift
Tuesday-Saturday(12am-8am, flexible start time)
Must be willing to work weekends when needed
Must be willing to start early based on processing needs.
NOTICEFORINTERNALAPPLICANTS
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.
VETJOBS
MSJR
Employees working in roles that the Company determines require routine collaboration with external stakeholders, such as customer-facing commercial, or research-based roles, will be expected to comply not only with Company policy but also with policies established by such external stakeholders (for example, a requirement to be vaccinated against COVID-19 in order to access a facility or meet with stakeholders). Please understand that, as permitted by applicable law, if you have not been vaccinated against COVID-19 and an essential function of your job is to call on external stakeholders who require vaccination to enter their premises or engage in face-to-face meetings, then your employment may pose an undue burden to business operations, in which case you may not be offered employment, or your employment could be terminated. Please also note that, where permitted by applicable law, the Company reserves the right to require COVID-19 vaccinations for positions, such as in Global Employee Health, where the Company determines in its discretion that the nature of the role presents an increased risk of disease transmission.
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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, generally Tuesday, Wednesday and either Monday or 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”.
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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.
Employee Status:
RegularRelocation:
No relocationVISA Sponsorship:
NoTravel Requirements:
No Travel RequiredFlexible Work Arrangements:
Not ApplicableShift:
3rd - NightValid Driving License:
NoHazardous Material(s):
n/aJob Posting End Date:
05/23/2024Job Posting End Date:05/23/2024
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.
Requisition ID:R295954
Full Time
Pharmaceutical
$54k-75k (estimate)
05/23/2024
05/25/2024
merck.com
KENILWORTH, NJ
>50,000
1960
KENNETH C FRAZIER
$10B - $50B
Pharmaceutical