Director of GMP Analytical, Pharmaceutical Analytical Sciences

Job Description The Pharmaceutical Analytical Sciences team has an opening for a GMP Analytical Director based in Rahway, NJ. Join us and experience our culture first-hand - 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. In this role, the Director will lead a team of scientists in Rahway supporting various GMP analytical activities including method validation, clinical release, and stability testing for drug substance and drug product across the entirety of our small molecule clinical portfolio (oral solid dosage forms and sterile liquids). The Director is responsible for ensuring cGMP compliance and operational excellence in the laboratories, and for maintaining a state of inspection readiness. The Director should be engaged with regulatory and industry trends and have thorough working knowledge of cGMPs, ICH, and relevant FDA guidelines. In addition, the Director will effectively team with the Pharmaceutical Analytical leadership, and extended leadership teams to identify and advance key departmental strategic and cultural initiatives. The Director will identify, recruit, onboard, and develop employees to their full potential. The role will also be responsible for proactive resourcing planning, risk assessment strategies, and budget management as necessary. Primary Responsibilities Essential knowledge and responsibilities include: Technical expertise in analytical methodologies such as liquid chromatography, spectroscopy, titration, and dissolution Strong project management skills, able to maintain oversight of multiple programs with evolving timelines Ensuring on-time, right first-time analytical testing per SOPs to enable clinical manufacture of drug substance and drug product Provide technical and compliance oversight on lab investigations and deviations including root cause analysis and identification of robust corrective and preventative actions Review and approval of GMP data, release specifications, analytical reports, Certificates of Analysis, and SOPs Serve as analytical lead during internal and external compliance audits Ensure operational excellence and drive process improvements within the laboratory Talent recruiting and employee development Cross-functional leadership including working with senior management to drive departmental strategic and cultural initiatives Education Minimum Requirements: BS in Chemistry or related science with at least 12 years of industry experience with pharmaceutical drug substance and/or product development. MS in Chemistry or related science with at least 10 years of industry experience with pharmaceutical drug substance and/or product development. Ph.D. in Chemistry or related science with at least 8 years of industry experience with pharmaceutical drug substance and/or product development. Required Experience and Skills · Proven leadership in an analytical laboratory, preferably in a GMP environment Demonstrated coaching and talent development skillsets Excellent communication and written skills Demonstrated creativity, effective interpersonal and collaborative skills Ability to work in a team environment with cross-functional interactions is essential Strength in delivering right first-time results on firm deadlines; preferably in support of small molecule drug substance and/or drug product clinical needs Required Skills: Analytical Method Development, Analytical Reports, Analytical Testing, Biologics License Application (BLA), Chromatographic Techniques, Compliance Oversight, Dosage Forms, GMP Compliance, Inspection Readiness, People Leadership, Pharmaceutical Management, Process Analytical Technology (PAT), Project Management, Regulatory Compliance, Regulatory Submissions, Risk Analysis, Risk Assessments, Risk Evaluation And Mitigation Strategy (REMS), Spectroscopy, Talent Development, Team Leadership, Technical Writing Preferred 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. As an Equal Employment Opportunity Employer, we provide equal opportunities to all employees and applicants for employment and prohibit discrimination on the basis of race, color, age, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability status, or other applicable legally protected characteristics. As a federal contractor, we comply with all affirmative action requirements for protected veterans and individuals with disabilities. For more information about personal rights under the U.S. Equal Opportunity Employment laws, visit: EEOC Know Your Rights EEOC GINA Supplement​ We are proud to be a company that embraces the value of bringing together, talented, and committed people with diverse experiences, perspectives, skills and backgrounds. The fastest way to breakthrough innovation is when people with diverse ideas, broad experiences, backgrounds, and skills 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 The salary range for this role is $173,200.00 - $272,600.00 This is the lowest to highest salary we in good faith believe we would pay for this role at the time of this posting. An employee’s position within the salary range will be based on several factors including, but not limited to relevant education, qualifications, certifications, experience, skills, geographic location, government requirements, and business or organizational needs. The successful candidate will be eligible for annual bonus and long-term incentive, if applicable. 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 https://jobs.merck.com/us/en/compensation-and-benefits . You can apply for this role through https://jobs.merck.com/us/en (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 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: Regular Relocation: Domestic VISA Sponsorship: Yes Travel Requirements: 10% Flexible Work Arrangements: Not Applicable Shift: Not Indicated Valid Driving License: No Hazardous Material(s): n/a Job Posting End Date: 08/15/2026 *A job posting is effective until 11:59:59PM on the day BEFORE the 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: R408297