Job Description

The Pharmaceutical Analytical Sciences team has an opening for a GMP Analytical Director based in Rahway, NJ. 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:

Preferred Skills:

Current Employees apply HERE

Current Contingent Workers apply HERE

US and Puerto Rico Residents Only:

The salary range for this role is

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:

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.