Specialist, Project Management

Job Description

Our company's Pharmaceutical Sciences and Clinical Supply (PSCS) organization translates molecules to medicines, working from the discovery interface through registration stability manufacturing by designing, developing and scaling-up the formulation, device, and manufacturing process. Driving drug product design from the bench to Good Manufacturing Practice (GMP) manufacturing facilities, our scientists and engineers use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients. The External Development and Manufacturing (ExDM) team within PSCS is focused on executing our Company's Research Laboratories drug product sourcing strategy across all phases of small and large molecule research and development operations.

The successful candidate will be accountable for managing the execution of formulation development and cGMP drug product batch manufacturing campaigns at external providers as part of a matrix team including product development teams and internal partner groups (quality, analytical, procurement, and global clinical supply). Projects may include solid oral dosage forms (tablets, capsules), sterile injectables, or specialty dosage forms (inhaled, implants) delivering small molecules, biologics or vaccines. They will also design and implement strategies to realize new manufacturing technologies and dosage forms using the external network. The candidate will also have opportunities to improve business practices and work with project teams on the technical aspects of products in development.

Additional job duties include:

• Outsource and coordinate formulation development and/or clinical manufacturing at Contract Research Organization (CROs)/Contract Manufacturing Operation (CMOs)

• Manage vendor relationships and maintain an understanding of current vendor capabilities in the pharmaceutical industry

• Provide manufacturing and compliance expertise to project teams

• Support Pharmaceutical Sciences technology development efforts by sourcing external services such as equipment trials, research collaborations, software trials, etc.

• Collaborate effectively within and across functional areas and possess advanced knowledge or experience in a specialized scientific area; bring knowledge and creativity to the position as well as have the discipline to drive results

• Identify and champion continuous improvement projects for the workflows within the group

• Collaborate effectively with critical partner groups such as Procurement, Quality and Global Clinical Supply (GCS)

Note: This position is available either in Rahway, NJ or West Point, PA based on candidate preference.

Education:

• A minimum B.S. degree in Chemical Engineering, Pharmaceutical Sciences or related field with two (2) years relevant industrial experience

Required Experience and Skills:

• Prior experience with development and/or manufacturing of drug products/drug substance or relevant technical experience

• Ability to work effectively with team members of diverse skill sets and backgrounds

Preferred Experience and Skills:

• Hands-on experience in pharmaceutical pilot plants

• Knowledge of cGMP requirements for drug product manufacture

• Direct experience of working with external suppliers

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 separationpackage, 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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Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

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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. We are an equal opportunity employer, committed to fostering an inclusive and diverse workplace.

U.S. Hybrid Work Model

Effective September 5,2023 our U.S. Hybrid work model will be as follows: 1. Three total days on site per week: Tuesday and Wednesday – plus one additional day of choice based on what works best for organizations and/or teams. 2. Fridays will formally be a remote-working day unless business critical tasks require onsite presence.

Under New York City, 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:

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.

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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:

Relocation:

VISA Sponsorship:

Travel Requirements:

Flexible Work Arrangements:

Shift:

Valid Driving License:

Hazardous Material(s):

Requisition ID:R253859