Executive Director, Engineering - FLEx Co-Lead job in Rahway
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New Jersey (NJ),
Rahway
| Job Code: | MERCUSR291845ENUS |
| Employer: | Merck & Co. |
| Category: | Engineering |
| Job Type: | Full Time |
| Location | |
| Country: | United States |
| State: | New Jersey (NJ) |
| City: | Rahway |
| Post Date: | 04/26/2024 |
| Description | |
|
Job Description FLEx is a set of multi-modality Drug Product development and GMP clinical manufacturing assets being constructed in the Rahway, New Jersey site, to support our company's diverse and growing pipeline of oral and injectable therapeutics and vaccine drug products. Operational leadership of the FLEx complex is shared across two co-leader roles, and includes operations that support end-to-end GMP clinical supply manufacture and product/process development, as well as oversight of the Enterprise Resource Planning systems (SAP, PAS-x) and the Data Analytics output of those areas. -The RY119, RY53 and RY80B facilities are fully operational, along with the non-sterile portion of the RY880 building.- The sterile portion of RY880 is in commissioning/qualification/validation. Successfully delivering on the entire scope of FLEx, including the qualification and validation work in the RY880 sterile modality, is a key near-term focus for the FLEx Co-Leads. The FLEx Co-Leads are jointly accountable for all activities associated with FLEx, including the realization of the overall FLEx intent in Pharmaceutical Sciences and Clinical Supply (PSCS) organization.- This includes operating model, culture, talent development, technology introduction, and compliance.- However, one co-lead remains focused on non-sterile pipeline programs and infrastructure while one co-lead remains focused on sterile pipeline programs and infrastructure.- The FLEx Co-Lead role is based in New Jersey and reports to the Associate Vice President of Pharmaceutical Operations and Clinical Supply in our Research and Development Division (R&D).- The current opening is focused on the non-sterile pipeline and infrastructure. The FLEx Co-Leads are responsible for providing tactical and strategic level direction to the cross-functional teams working in the set of FLEx assets in RY880, RY53, RY53 and RY80B.- This extends from materials management, weigh and dispense, GMP manufacture, formulation development, and bulk Drug Product release.- Close connectivity with upstream Drug Substance and downstream packaging partners is required to optimally support clinical development and product commercialization. The FLEx Co-Leads are responsible for creation and management of the performance management processes that govern operations, including tier, clinical siting and compliance councils. Key performance indicators range from quality and regulatory compliance, operational excellence, pipeline program support, financial, talent development and diversity/equity/inclusion.- Key to the realization of FLEx is the creation of a collaborative scientific community that inspires innovation and enables speed of new product development from clinical research to commercialization of robustly understood products and processes. The FLEx Co-Leads have direct management responsibilities for a staff that is expected to grow to >150 FTEs and contractors in the 2-year window, along with a matrixed reporting relationship to functional groups in development, quality, safety, facilities management, analytical, finance and regulatory.- FLEx was designed to be a facility that evolves to meet company and pipeline needs over its entire lifetime.-As such the FLEx Co-Leads are responsible for understanding the external and internal drivers of change, translating that to a local FLEx strategy, securing support for that strategy with partners and R&D Senior Leadership, and executing on plans to deliver the strategy.- This is inclusive of business process development, governance structure, talent development, innovation and delivery of technology, and defining the cultural attributes required for the area's success.-Significant focus will be placed on adoption of new digital capabilities that allow for better access to high-fidelity data, more efficient clinical product release, improved product/process characterization, and more successful commercialization of new products into our Manufacturing Division. Primary Responsibilities include but are not limited to:
Education:
Required Experience and Skills:
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. 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 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, 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". Under New York State, Colorado State, Washington State, and California State law, the Company is required to provide a reasonable estimate of the salary range for this job. 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 salary range: $220,700.00 - $347,500.00 Available benefits include bonus eligibility, health care and other insurance benefits (for employee and family), retirement benefits, paid holidays, vacation, and sick days. - For Washington State Jobs, 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:05/04/2024 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:R291845 | |
ref: (MERCUSR291845ENUS) 13 days ago
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