Job Description
Job Description Job Description: The Formulation, Laboratory, and Experimentation (FLEx) Center is a multi-modality (small molecule, biologics, vaccine) Drug Product development and clinical manufacturing facility in Rahway, New Jersey.- This team works with non-sterile formulations, typically oral solid dosage (blending, roller compaction, encapsulation, tableting) though also including spray dried intermediates, liquid suspension/bottle fills, and autoinjector assembly. We are part of the research division, focusing on development and clinical deliveries in a GMP piloting facility supporting our company's research division.
The Oral Solids Dosage (Non-Sterile) team at the FLEx Center in Rahway is looking for an Specialist - Process Engineer to lead clinical supply manufacturing, scientific rigor of processes, and ultimately to enable flexibility and speed of our company's pipeline.
This person will:
- Lead and strategically plan on-the-floor batch manufacturing to ensure safety and quality of clinical supplies to augment and accelerate our products.
- Draft and execute GxP documentation including but not limited to batch records, equipment qualification and cleaning, change records and deviations.
- Build partnerships by developing and leveraging relationships within and across work groups of formulators, engineers, safety and quality representatives.
- Foster culture of collaboration, learning and innovation.
Required Experience and Skills: - Experience executing GxP manufacturing in pilot plant environment.
- Experience of interest in supporting electronic batch records and MES systems.
- Knowledge and experience of drug product processing.
- Desire and willingness to learn and contribute through independent problem-solving.
- Experience in leading and supporting quality investigations and change management.
Education Minimum Requirements: - Associate's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related field with a minimum of 4 years relevant experience
- Bachelor's in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 2 years relevant experience
- Master's degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 1 year relevant experience
Preferred Experience and Skills: - Knowledge of Investigational drug regulatory requirements
- Understanding of Clinical Supply Chain Operations
- Experience with Commissioning, Qualification and Validation
- Experience with spray dried intermediates and/or hot melt extrusion
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 separationpackage, then you are no longer eligible for your separation benefits package. To discuss in more detail, please contact your HRBP or Talent Acquisition Advisor.
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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. Current Employees apply HERE
Current Contingent Workers apply HERE
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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, 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".
The Company is required to provide a reasonable estimate of the salary range for this job in certain states and cities within the United States. Final determinations with respect to salary will take into account a number of factors, which may include, but not be limited to the primary work location and the chosen candidate's relevant skills, experience, and education.
Expected US salary range:
$83,100.00 - $130,900.00
Available benefits include bonus eligibility, long term incentive if applicable, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. A summary of benefits is listed here .
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: Not Indicated
Valid Driving License: No
Hazardous Material(s): N/A
Job Posting End Date: 09/17/2024
*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. Job Posting End Date: 09/17/2024
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: R310757
Job Tags
Holiday work, Full time, Remote job, Relocation, Visa sponsorship, Flexible hours, Shift work, 3 days per week,