Director of GMP Analytical, Pharmaceutical Analytical Sciences

Merck•Rahway, NJ

1d•$173,200 - $272,600•Onsite

About The Position

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.

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.
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

Nice To Haves

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

Responsibilities

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