Director, Small Molecule Analytical Research & Development GxP Strategic Lead

Job Description

The Small Molecule Analytical Research and Development (SMAR&D) group has an exciting opportunity for a Director role as GxP Strategic Lead based in Rahway, NJ. Join us and experience our culture firsthand - one of strong ethics & integrity, diversified experiences, exceptional science, and a resounding passion for improving human health through innovative drug delivery technologies and predictive analytical tools. As part of our global team, you will have the opportunity to collaborate with talented and dedicated colleagues while developing and expanding your career.  

As GxP Strategic Lead, you will be part of a team that supports execution of analytical methodologies to characterize and release raw materials, package components, clinical drug substance, and clinical drug product for our small molecule portfolio. In this role, you will work with the GMP Analytical and Raw Materials teams on strategies associated with Operational Excellence. The role also involves strategic partnering with Development Quality, Process Research & Development, Pharmaceutical Operations, and other parts of the AR&D organization in aspects of quality control and compliance. Your main responsibilities will include: 

Strategy and Operational Excellence:

• Driving operational deliverables including timely release of clinical materials by actively partnering with the GxP 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 GMP processes while maintaining high-level of compliance and 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 via presentations to key partner groups or serving as a subject matter expert during GxP 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.

• Planning critical business needs, which can include impact of the external business, regulatory, and compliance environment.

• 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 necessary to qualify for this role. Additional skills:

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

• Possess strategic experience in operational control strategy development and execution.

• Demonstrated ability for taking initiative, creativity, and innovation in problem solving.

• 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: ​

• Ability to design, execute and/or direct the development and qualification of release, characterization, and stability assays for testing of clinical trial material and in support of product and process development.

• Project management skills

• Established scientific or regulatory reputation supported by publications and/or external presentations.

#AR&D

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.

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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, 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

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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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