Job Description

　　The FLEx Center is a newly established Drug Product development and GMP clinical manufacturing plant in Rahway, New Jersey. It is designed to cater to multiple modalities including small molecules, biologics, and vaccines. Within the facility, the sterile section comprises two cutting-edge filling suites that possess multi-format, potent and lyophilization capabilities. Currently, the first filling suite is undergoing qualification and validation, while the second suite is still in the design phase. These state-of-the-art filling suites, along with the diverse stages of the projects, provide exceptional prospects for individuals to enhance their leadership skills and achieve professional growth.

　　The primary mission of the FLEx group is to facilitate the speed, agility, and rigor of our company's pipeline products. This will be accomplished through several key strategies:

　　Facilitating robust formulation and process development by leveraging flexible physical and digital infrastructure.

　　Ensuring the timely delivery of compliant and high-quality clinical supplies, with a focus on getting it right the first time.

　　Nurturing talent through the implementation of a new operating model that promotes a growth mindset and fosters the development of employees.

　　The FLEx Sterile Operations team is actively seeking highly motivated individuals for the role of Director, FLEx Sterile. This position offers significant opportunities to contribute to the 2nd filling suite capital project right from its initiation phase. The successful candidate will have a wide range of responsibilities, including but not limited to leading matrix teams, supporting the design and initiation of the second filling suite, attracting and developing staff members for the sterile operations team, and collaborating with the broader organization to establish systems and processes at the Rahway site.

　　This Director role provides a unique prospect for the suitable candidate to lead, collaborate, and drive initiatives within a dynamic environment that spans from capital projects to GMP operations. The selected individual will have the opportunity to work with both filling suites, initially focusing on leading the design of the 2nd filling suite and supporting the initiation of this significant capital project. Additionally, there may be opportunities to support the start-up and ongoing operations of the 1st filling suite. Apart from technical and operational responsibilities, the successful candidate will play a crucial role in developing world-class talent and fostering a stimulating, diverse, creative, and learning culture within the organization.

　　By taking on this role, the selected candidate will be an integral part of shaping the future of FLEx Sterile Operations and contributing to the growth and success of the organization as a whole. Your leadership and strategic decision-making abilities will be crucial in driving productivity, efficiency, and innovation. Additionally, you will have the opportunity to collaborate with cross-functional teams, leveraging their expertise and resources to ensure the successful implementation of key projects and objectives.

　　Based in New Jersey, this role reports to the Executive Director of Clinical Sterile Operations in Pharmaceutical Operations and Clinical Supply. While the position initially starts as an individual contributor role, there is the potential for it to progress into a people management position. Occasionally, weekend and night shifts may be required.

　　Required Experience and Skills:

　　Bachelor's or Master's degree in Engineering, Pharmaceutical Sciences, or a related field with a minimum of 8 years of experience in plant operations within the Pharmaceutical or Biopharmaceutical industry.

　　Extensive experience in aseptic GMP manufacturing.

　　Working knowledge of regulatory requirements in compliance with GMPs and industrial hygiene (IH) requirements.

　　Demonstrated leadership skills, including talent development, stakeholder management, and strategy setting and execution.

　　Strong oral and written communication skills.

　　Excellent planning, scheduling, and time management abilities.

　　Preferred Experience and Skills:

　　Experience with equipment and facility qualification.

　　Product development experience.

　　Proficiency in computer systems and applications, including ERP/MES systems.

　　Change management experience.

　　Experience in influencing business partners and prioritizing resources.

　　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 (https://wd5.myworkday.com/msd/d/inst/1422$1533/rel-task/3001$14.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, 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:

　　$159,200.00 - $250,700.00

　　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 (https://www.benefitsatmerck.com/) .

　　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:

　　VISA Sponsorship:

　　Travel Requirements:

　　Flexible Work Arrangements:

　　Shift:

　　Valid Driving License:

　　Hazardous Material(s):

　　Requisition ID: R272946