Director of GMP Analytical, Pharmaceutical Analytical Sciences

About the role

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.

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
• Ensure 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
• Cross-functional leadership including working with senior management to drive departmental strategic and cultural initiatives

Requirements

• 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.
• 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

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
• Proven experience in 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

Qualifications

• 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

Benefits

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.

Pay

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.

Schedule

Shift Not Indicated