Job Description

Join us to be part of a team of inventors to make a change in our patients' life! Using innovative thinking, state-of-the-art facilities and robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our success is backed by ethical integrity, forward momentum, and an inspiring mission to achieve new milestones in global healthcare.

The primary objective of the Small Molecule Analytical Research and Development (SMAR&D) team is to carry out R&D activities partnering across the network to enable process and formulation development. In this position the SMAR&D Director will set guidance, lead activities, and develop a team whose roles include development of characterization methods to characterize and release clinical drug substance and product and their stability tests, raw materials/excipients, and packaging components for our research pipeline. This research opportunity contributes to the Development Sciences and Clinical Supplies (DSCS) deliverable which is the development of robust chemical and biochemical processes, market formulations and their processes for non-sterile and sterile products. It also includes strategic partnering with CMC and Regulatory in aspects of control strategy and filings, Quality and our partners in the commercialization and manufacturing division.

This challenging position requires deep understanding of new commercial product development and commercialization, proactively identifying risks to influence solutions, driving operational and scientific excellence, actively engaging in two-way communication to build trusting relationships, providing timely feedback and coaching to talent within their organizations, and solving problems in innovative ways to achieve results.

Nature and Scope of Position:

The Director reports to the Executive Director of SMAR&D and will lead a team in Rahway (~10-15 scientists) who work closely within multidisciplinary DSCS teams. This role has a wide responsibility for analytical method development, and testing for chemical and biochemical processes, parenteral, oral, and specialty dosage formulations. The director should be well engaged with regulatory and industry trends to guide future activities for Analytical R&D and DSCS. The candidate will have experience in an innovative analytical/regulatory/GMP environment.

The Director will effectively team with the SMAR&D leadership, and extended leadership teams in order to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard and develop employees to their full potential. The candidate will contribute and establish a viable succession plan for key positions within the functional area (scientific and management pathways), including their own role. The position is responsible for disclosures prepared within the group to be used as the basis for external publications and filings. The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.

Maintaining an effective network internally and across the external academic and regulatory community is expected, as well as advancing a culture of scientific excellence, GMP and compliance mindset and collaboration with various partners and stakeholders in development.

Essential Knowledge, Duties & Responsibilities include:

• Analytical Methodologies

• Project management skills

• Review and approval of data

• Representation of the laboratory for internal and external audits

• SOP development

• Quality System experience

• Team and staff development

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

Qualifications:

Education:

• BS or MS in chemistry or related science with 10 years of industrial experience with pharmaceutical drug substance and/or product development.

• Ph.D. in chemistry or related science with 7 years of industrial experience with pharmaceutical drug substance and/or product development.

Required:

• Demonstrated ability in leading teams with proven talent development skillsets.

• Excellent scientific communication skills, demonstrated creativity, effective interpersonal and collaborative skills

• Ability to work in a team environment with cross-functional interactions is essential

• Strength in delivering results on firm deadlines in support of drug substance and product development and commercial filing

#AR&D

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:

EEOC Know Your Rights

EEOC GINA Supplement

Pay Transparency Nondiscrimination

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.

Learn more about your rights, including under California, Colorado and other US State Acts

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:

Shift:

Valid Driving License:

Hazardous Material(s):

Job Posting End Date:

*A job posting is effective until 11:59:59PM on the day BEFOREthe listed job posting end date. Please ensure you apply to a job posting no later than the day BEFORE the job posting end date.

Requisition ID:R319845