Job Description

Job Description:

The GMP Operations branch of Biologics Analytical Research & Development (BAR&D) seeks a driven leader to advance and commercialize complex biotherapeutics.

The Director of Compliance, reporting to the Senior Director of GMP Operations, will oversee laboratory compliance across multiple sites, managing regulatory audits, internal quality and safety audits, quality notices, CAPA management as the business area representative, as well as release and stability programs. This position is in Rahway, NJ, and will foster an inclusive culture emphasizing quality and scientific rigor for a team of 8-10 scientists. Our BAR&D GMP Operations team validates analytical methods and performs release and stability testing for biologic therapies in clinical development, impacting global patient health and wellness.

Responsibilities include, but are not limited to, the following:

• Lead a team of scientists to conduct validations, technical transfers, and release and stability testing.

• Manage stability activities, including protocols, reevaluation dating, sample shipments, and execution of tests within specified windows for the North American GMP Operations team.

• Ensure inspection readiness and offer prompt support during regulatory, quality, and safety inspections.

• Address audit findings and identify trends to enhance laboratory compliance.

• Conduct laboratory investigations and collaborate with stakeholders to implement corrective or preventative actions.

• Develop and track internal compliance metrics and report the observed trends to senior management.

• Provide regulatory support by preparing or reviewing high-quality CMC sections for IND/CTA/NTAs.

• Timely communication and prompt delivery of analytical results to meet project milestones and regulatory requirements.

• Sets high standards, builds, and develops a high performing team.

• Collaborates with the leadership team to establish departmental goals and performance objectives, supports talent development initiatives, and proactively addresses performance-related issues.

• Recruits, hires, and develops talent to advance the organization.

Qualifications:

Education:

• PhD in relevant scientific discipline with 8+ years' experience; MS in relevant scientific discipline with 12+ years' experience; BS in relevant scientific discipline with 16+ years' experience

Required:

• Proven experience with GMP compliance in an analytical laboratory.

• Extensive experience in technical operations, including resource modeling and capacity planning.

• Expertise in analytical methodologies including SEC, IEX, CE, icIEF, qPCR, ELISA, cell-based potency, and compendial assays.

• Demonstrated proficiency in talent development through effective leadership and mentoring.

• Strong initiative, creativity, and innovation in problem-solving.

• Comprehensive knowledge of regulatory guidance and quality standards, with experience in authoring and reviewing regulatory submissions and responses, including biologics license applications, and engaging with Health Authorities.

• Substantial experience in technical problem-solving.

• Proficient in communicating scientific concepts, including writing and reviewing internal and external technical protocols and reports.

• Proven capability to achieve complex goals within stringent deadlines in a dynamic and evolving environment.

• Exceptional team player with excellent oral and written communication skills.

• Occasional travel required

Preferred:

• Proficiency with assay qualification, validation, and transfer to a GMP, GLP or regulated lab per ICH Q2 and USP<1033>.

• Experience with analytical testing for biologics, such as monoclonal antibodies (mAb), antibody-drug conjugates, and fusion proteins.

• Strong grasp of Critical Quality Attributes/QbD/DOE principles and statistical data analysis approaches.

#AR&D

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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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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:

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Travel Requirements:

Flexible Work Arrangements:

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Requisition ID:R327374