Director, Oral Formulation Sciences

Job Description

Director Oral Formulation Sciences Job Description:

Our companys 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 benchtop to current Good Manufacturing Practice (cGMP) manufacturing facilities our scientists use cutting edge science to transform drug delivery and manufacturing technology to positively impact patients.

The Director of Oral Formulation Sciences will lead a team of scientists and engineers responsible for the formulation and process development of our oral product pipeline. The individual will be accountable for driving program strategy and translating into effective execution from discovery exit through commercial process definition. The individual stands at the vanguard of commercial product development ensuring that our capabilities talent and operating model are developed and maintained to effectively foster a dynamic and complex pipeline. They will help to create an entrepreneurial culture which values diversity in all its forms as a catalyst to innovation and product creation recognizes the freedom to experiment and fail is a safe environment to challenge nurtures a strong sense of belonging and motivates all to achieve their potential. Critically the individual will drive a culture of perpetual adherence to safety and compliance standards. A successful candidate should have extensive drug product development experience an affinity for hands-on problem solving and excellent leadership and communication skills.

Primary Responsibilities:

• Drives development of new innovative approaches for product development experimental designs execution of experimental plans and data analysis to impact pipeline development and set strategic direction

• Manages develops and grows a team of scientists and engineers tasked with developing and commercializing the companys oral product pipeline

• Collaborates effectively within and across functional areas and possesses advanced knowledge or experience in oral drug product development. The desired individual is someone who will bring knowledge and creativity to the position as well as have the discipline to drive results

• Maintains awareness of relevant new and current technologies capabilities and effectively shares this knowledge with others

• Drives internal capability development by evaluating new drug product technologies and deploying new technologies to develop pipeline assets

• Establishes and manages expense and capital expenditure financial budgets and forecasts

• Recruits and develops staff through objective setting rewards and recognition stretch leadership and/or technical assignments and learning opportunities that broaden experience

• Sponsors and drives a culture of continuous improvement throughout the organization

Education Minimum Requirement:

Ph.D. degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 8 years of relevant experience or B.S. or M.S. degree in Chemical Engineering Chemistry Pharmaceutical Sciences or related scientific field with a minimum of 12 years of relevant experience

Required Experience and Skills:

• Knowledge of oral drug product formulation and process development

• Experience with cGMP manufacturing

• Effective interpersonal and communication skills both verbal and written

• Excellent organizational skills to handle multiple priorities

• Track record of independent problem-solving

• Experience with leading complex teams / matrix management

Preferred Experience and Skills:

• Experience leading development projects at an enterprise level

• Experience with leading organizational change

• Strong mentoring capabilities to build individuals and teams

• Demonstrated ability to apply the principles of physical/organic chemistry physical pharmacy and materials science to solve practical pharmaceutical development problems

• Recognized as a subject matter expert in drug delivery and/or manufacturing technology

• Demonstrated ability to identify characterize and solve development challenges

• Desire to build new capabilities through the evaluation of new technologies and optimization of existing technologies

• Ability to engage others to build a strong scientific community and address drug delivery challenges

• Demonstrated understanding of connectivity between clinical development chemistry manufacturing and control (CMC) and commercial marketing balancing the needs of patients and ensuring successful launch and stable supply of product

• Encourages others to explore alternative ways to view and solve problems in innovative ways to achieve results

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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 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 salary range for this role is

We offer a comprehensive package of benefits. Available benefits include medical dental vision healthcare and other insurance benefits (for employee and family) retirement benefits including 401(k) paid holidays vacation and compassionate and sick days. More information about benefits is available at can apply for this role through (or via the Workday Jobs Hub if you are a current employee). The application deadline for this position is stated on this posting.

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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