Manufacturing Director (Drug Substance)

Job Description

Our Manufacturing Operations teams are the people that make our products. We work in the manufacturing plants with a “Safety First, Quality Always” mindset striving for continuous improvement. We work in the local plant connected to our global manufacturing network to ensure the highest quality of raw materials, intermediates and finished products.

GENERAL SUMMARY

The Director of Operations (Integrated Process Team (IPT) Lead) is an exciting opportunity to lead a new manufacturing area at the Durham, North Carolina Site. This role will lead the operations team to deliver the facility startup, process validation, regulatory submission, PAI, and ultimately the commercial manufacture of the product's Drug Substance.

GENERAL PROFILE

• Provides leadership and direction to ensure that short and long term IPT objectives are achieved while reliably supplying quality product at a competitive cost and consistent with our company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing practices (GMP), equal employment opportunity, finances, labor, employee, environment, and safety.

• Develops and cultivates a Production System (MPS) and continuous improvement culture while achieving MPS Targets and business outcomes for the IPT.

• Creates and sustains a highly engaged workforce through utilization of Enterprise Leadership Skills and Inclusion.

• Provides guidance and makes decisions to ensure the safety of the employees is always maintained.

• Development and management of the IPT operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost.

• Resolves complex technical, operational, and financial problems.

• Prioritizes based on departmental budget and profit plan to address resource and operational challenges.

• Leads and directs the operations organization of approximately 100 through managers, individual contributors, and technicians.

• Develops business plans, including financial, production and/or organizational priorities.

• Prioritizes based on departmental budget and profit plan to address resource and operational challenges.

• Leverages relationships with key clients and/or customers to support business needs.

PEOPLE MANAGEMENT

• Leads Production team for the new Durham, NC HPV Bulk manufacturing organization, including associate directors, coaches, technicians and engineers (~100 people)

• Provides coaching on professional development and career paths. Provide timely feedback and performance evaluations for direct reports after obtaining the relevant input and evaluation. Provide feedback and input on performance evaluations for indirect IPT reports.

FINANCIAL MANAGEMENT

• Responsible for development and management of the IPT operating budget as defined with the profit plan. Accountable for meeting the operating budget and continuously reducing cost; Ensure members of the IPT have high business acumen and understand how they may impact business finances.

QUALIFICATIONS

Essential:

• Bachelor Degree in Engineering, Science or related field

• Minimum 10 years of experience in Manufacturing, Technical Operations, Management Engineering, Science & Technology, Site Engineering Services with extensive supervisory responsibility with exempt and hourly personnel

• Demonstrated knowledge of High Performing Organization tools and methodology, including MPS/Iean processing

Preferred:

• Demonstrated ability to create an engaged workforce

• Demonstrated experience of interacting with regulatory agencies via on-site inspections

• Demonstrated successes with Talent Management, reorganization and strategic initiative

Note: This description is not intended to be all-inclusive or a limitation of the duties of the Job. It is intended to describe the general nature of the job that may include other duties as assumed or assigned.

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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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”.

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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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