Director, FLEx Non-Sterile Production

Job Description

The Formulation Laboratory and Experimentation (FLEx) Center in Rahway, New Jersey provides a launch pad for the commercial formulation development and GMP clinical supply manufacture of our company's drug product pipeline.  The FLEx Non-Sterile Production Lead will steer this facility within the FLEx network.  They will collaborate closely with scientists and engineers from the research and manufacturing divisions in the development of formulations in support of oral and combination products using the talent, capabilities, and facilities of the FLEx Center.  They will be responsible for operating and maintaining a compliant, GMP-licensed manufacturing facility with the capability to manufacture supplies for early and late phase clinical trials.  Close partnership with supply chain colleagues from Quality, Regulatory Affairs, Facilities Management, Engineering, and Analytical will be required to ensure effective utilization of the facility in support of clinical development.   

The Production Lead is the steward of this key our company asset, ensuring its capabilities and operating model are developed and maintained over time to effectively support a dynamic and complex pipeline.  The Lead will sponsor and drive continuous improvement to realize the vision of the FLEx Center as a learning facility, founded on more inclusive collaboration in a workforce of great diversity, to enable the promise of the pipeline and more fully develop our talent.  They will help to create an entrepreneurial culture which values diversity in all its forms as a catalyst to innovation and product creation, recognizes the freedom to experiment and fail, is a safe environment to challenge, nurtures a strong sense of belonging, and motivates all to achieve their potential.  Critically, the Lead will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have GMP facility operations experience, an affinity for hands-on problem solving, and excellent leadership and communication skills.

The role is based in New Jersey and reports to the Executive Director of FLEx Non-Sterile Operations in Pharmaceutical Operations & Clinical Supply. 

Primary Responsibilities:

• Oversee facility readiness including but not limited to equipment / facility cleaning and calibrations, materials availability, safety and environmental conditions to support development or GMP activities

• Manage, develop, and grow a team of facility-facing engineers and technicians

• Provide trouble shooting support on the shop floor

• Support internal capability development by evaluating new drug product technologies and deploying new technologies to develop pipeline assets

• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results.

• Maintain awareness of relevant new and current technologies, capabilities, and effectively share this knowledge with others

• Participate in external and internal audits, tours, and inspections

• Ensure closure of investigations, as needed

• Establish and manage expense and capital expenditure financial budgets and forecasts associated with the FLEx Center

• Maintain facility and equipment systems in a state of permanent inspection readiness

• Recruit and develop staff, through objective setting, rewards and recognition, stretch leadership and/or technical assignments, and learning opportunities that broaden experience

• Sponsor and drive a culture of continuous improvement across this facility

Education Minimum Requirement: 

Ph.D. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 7 years of relevant experience or B.S. or M.S. degree in Chemical Engineering, Chemistry, Pharmaceutical Sciences or related scientific field with a minimum of 10 years of relevant experience

Required Experience and Skills:

• Knowledge of drug substance or drug product processing

• Experience with GMP manufacturing

• Effective interpersonal and communication skills, both verbal and written

• Excellent organizational skills to handle multiple priorities

• Track record of independent problem-solving

• Experience with leading complex teams / matrix management

Preferred Experience and Skills:

• Experience with GMP facility operations

• Experience with leading organizational change

• Experience in leading and supporting quality investigations and change management

• Experience with quality systems

• Familiarity with US and EU GMP and Safety compliance regulations

• Experience with SAP, ERP or MES systems

• Familiarity with computer systems and applications including but not limited to: Programmable Logic Controllers (PLCs), Calibration/Maintenance Database Systems

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.

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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:

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.

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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. 

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