Job Description
The Associate Director, Clinical Supply Operations (CSO) within Global Clinical Supply (GCS) is responsible for supporting launch and subsequently overseeing the clinical supply packaging and distribution operations at our Company at Rahway Cold Chain Center. This role involves working with stakeholders, subject matter experts, and customers within and outside of GCS to ensure efficient and compliant processes, as well as business continuity.
Key responsibilities of the Associate Director, Clinical Supply Operations include:
Supporting the implementation and leading the operational readiness of a new clinical cold chain supply packaging and distribution operation in Rahway.
Overseeing the Cold Chain Center's distribution, inventory, and warehouse activities, including inventory management, metrics, utilization, and inspection readiness once the facility is live.
Ensuring efficient and compliant processes by owning and contributing to the development of standard operating procedures (SOPs) specific to the Cold Chain Center as well as ensuring representation of the Cold Chain Center in harmonized global procedures.
Effectively collaborate with other CSO nodes, including partner group interaction optimization (Packaging, Label Room, Ops Planning, Quality, Master planning, Bulk manufacturing, Analytical for cleaning/swabbing/investigations) to enable business continuity and portfolio needs
Build partnership with quality teams to ensure agility and speed in meeting portfolio needs.
Flexibly managing responsibilities and activities across CSO workstreams to support the business.
Collaborating closely with Global Clinical Trial Operations (GCTO) and Regulatory teams to ensure regulatory needs are included in the clinical supply chain and on-time arrival of products.
Conducting capacity modeling and resource management, including presenting to leadership.
Partnering with drug product manufacturing to develop, implement, and maintain playbooks and processes for integrated operations within clinical supply.
Seeking opportunities for innovation and process improvement, and supporting change as needed.
Education Minimum Requirement:
Required Experience and Skills:
At least 7-10 years of experience in production operations, technical project management, engineering, and/or management role within the pharmaceutical industry, with an understanding of clinical supply needs, GMP, packaging, and distribution operations.
Experience in pharmaceutical packaging and distribution operations will be highly valued.
Strong understanding of current Good Manufacturing Practices (cGMP), including FDA and EMEA requirements.
Experience in leading teams, developing talent, and mentoring or leading complex projects.
Demonstrated strong project leadership of cross-functional teams through project planning and execution.
Experience in collaborating with vendors or other external partners.
Ability to work effectively across boundaries and build strong collaborative relationships with other groups.
Strong abilities in stakeholder management and building cross-functional networks.
Excellent communication skills with the ability to effectively communicate with different global professional levels and external stakeholders.
Demonstrated ability to prioritize tasks and manage multiple responsibilities.
Preferred Experience and Skills:
Experience with cold chain clinical supply packaging and distribution operations
Experience with clinical trial operations
Familiarity with SAP
Operations Management Certification (i.e., APICS (American Production and Inventory Control Society))
Six Sigma certification (i.e., Green or Black Belt).
Project management, lean six sigma, scheduling practices preferred
Comfortable with Microsoft suite of applications
Dedication to solving complex problems with a creative mind and imaginative strategies.
Understanding of scheduling and capacity modeling to ensure appropriate resourcing.
GCSCareer
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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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:
$122,800.00 - $193,300.00
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:
No relocation
VISA Sponsorship:
No
Travel Requirements:
10%
Flexible Work Arrangements:
Not Applicable
Shift:
1st - Day
Valid Driving License:
No
Hazardous Material(s):
n/a
