Director, Small Molecule AR&D Strategic Operations Lead

Job Description

The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a director role as Strategic Operations Lead based in Rahway, NJ. As the Strategic Operations Lead within the SMAR&D GxP Operations group, you will drive the strategy and logistics for the team responsible for analytical release of raw materials, package components, medical device components, clinical drug substance, and clinical drug product for our small molecule portfolio.

In this individual contributor role, you will help define the business and operational strategies enabling analytical release and ensure operational excellence across the GxP analytical team. The role also involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization to deliver on the small molecule portfolio. Your main responsibilities will include: 

Strategy and Operational Excellence:

• Driving operational deliverables including timely release of clinical materials by actively partnering with the Analytical teams and other functional areas.

• Serving as the analytical point of contact for key partner groups, maintaining open and active communication.

• Defining and implementing operational control strategies to ensure efficient and compliant processes while maintaining scientific rigor.

• Proactively identifying and escalating operational risks.

• Partnering with director-level management to develop and execute operational and enterprise strategies.

Leadership:

• Representing the team and/or department in strategic and operational discussions with key partner groups.

• Serving as a subject matter expert during audits and inspections.

• Fostering strong collaborations with internal stakeholders and external partners by actively engaging in two-way communication to build trusting relationships.

• Serving as a facilitator and mentor to empower others to succeed.

Impact and Influence:

• Anticipating and solving operational problems that may have broad impact to the business.

• Promoting our Company's scientific excellence and regulatory influence through leadership in the scientific community.

Qualifications

Education Minimum Requirements

Applicants must hold one of: ​

• PhD Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 7 years of pharmaceutical industry experience​.

• Master’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 10 years of pharmaceutical industry experience. ​

• Bachelor’s Degree in Analytical Chemistry, Biochemistry, Pharmaceutical Sciences or related fields with at least 12 years of pharmaceutical industry experience.   ​

Required Experience and Skills

A strong team player with excellent written and oral communication skills, as well as strong leadership and interpersonal skills are essential to this role. Additional skills:

• Experience in operational control strategy and execution.

• Thorough working knowledge of GMPs, ICH, and relevant FDA guidelines.

• Demonstrated track record of taking initiative, creative problem solving, and innovation.

• Strong ability to deliver complex objectives under aggressive timelines in a rapidly changing environment.

• Demonstrated technical or operational leadership with significant and measurable project impact.

• Demonstrated ability to develop talent through good mentoring skills.

Preferred Experience and Skills ​

While not required, experience in one or more of the following areas is preferred: ​

• Project management skills

Current Employees apply HERE

Current Contingent Workers apply HERE

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 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:

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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, Monday - 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.

San Francisco Residents Only: We will consider qualified applicants with arrest and conviction records for employment in compliance with the San Francisco Fair Chance Ordinance

Los Angeles Residents Only: We will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws, including the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance

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:

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Job Posting End Date:

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