"Lighting a Path to the Future"

AD, Analytical Development

Location: Madison, NJ
Job Type: Direct Hire
Salary: $140,000.00 - $150,000.00
Date: 11/7/2017
Job ID: 02533117
Job Description
Top Tier Global Pharmaceutical company in New Jersey is expanding:
Looking for a strong Professional with Regulatory and 

Associate Director, Analytical Development  
bold, global pharmaceutical company and a leader in a new industry model – Growth Pharma.  we are focused on developing, manufacturing and commercializing branded pharmaceuticals and biologic products for patients around the world. We market a portfolio of best-in-class products that provide novel treatments for the central nervous system, eye care, medical aesthetics and dermatology, gastroenterology, women's health, urology, anti-infective and cardiovascular therapeutic categories. With commercial operations in approximately 100 countries, we are committed to working with physicians, healthcare providers and patients to deliver innovative and meaningful treatments that help people around the world live longer, healthier lives.  Our success is powered by our world-class team’s commitment to being Bold for Life. Together, we build bridges, power ideas, act fast and drive results for our customers and patients around the world by always doing what it is right.
Join one of the world’s fastest growing pharmaceutical companies!
You will have the opportunity to thrive in a fast-paced, strategic environment where bold, innovative thinking isn’t just welcomed, it’s encouraged. Across all functions, we relish the opportunity to help our people fulfill their potential. Our rapid growth strategy means plenty of opportunities to step into the spotlight.
Position Description
The Chemical Development organization is responsible for the design and development of safe, efficient, and robust processes for the manufacturing of APIs. The development and manufacturing activities are conducted through CMOs and CROs, where appropriate analytical methods need to be in place to control the quality of raw materials, intermediates and final API.   
The Manager/Associate Director in Chemical Development group will be responsible for providing analytical support to the execution of the drug substance (API)  process development activities, as well as oversight of analytical activities conducted at CROs/CMOs for process development, process optimization, technology transfer, manufacturing, validation and regulatory filing activities.
Main Areas of Responsibilities
  • Under the supervision of the Director, Chemical Development, provide analytical support to the chemical development of New Chemical Entities (small molecules), in line with the CMC-Sub team and core-team objectives, and in particular:
  • Ensure that all methods for starting materials, intermediates, in-process controls, and final API are adequate for the control of process-related impurities.
  • Liaise with cross-functional teams to ensure consistency of methods, impurity control and quality control across the Drug Substance manufacturing process and to assure the quality of final API used for non-clinical and clinical studies, registration and validation activities.
  • Contribute to the API regulatory strategy, including for the selection and control of regulatory starting materials and potential genotoxic impurities.
  • Contribute to risk analysis and mitigation plans to secure timelines, cost, and quality at all stages of project progression.
  • Manage and ensure proper execution of analytical development and validation work conducted by Contract Research, Development and Manufacturing Organizations (CRDMO).
  • Assist Procurement in preparing Requests for Proposals, and through the CDMO selection process.
  • Coordinate, monitor and evaluate project progression at CDMO, and timeliness and quality of deliverables.
  • In collaboration with the Quality Assurance department, ensure that all laboratory, pilot scale and manufacturing activities are executed in compliance with the appropriate regulation and cGMP where applicable.
  • Write and/or review Drug Substance regulatory documents including IND, NDA, SNDA, MAA submissions, briefing books, DMF, and other regulatory submission documents and updates.
  • Assist in troubleshooting analytical methods and drug substance manufacturing processes when required.
  • Ensure proper communication and reporting to the Chemical Development organization, CMC leads, and other functions.
  • Provide appropriate analytical support to Chemical Development for the scientific evaluation of APIs during in-licensing opportunities.
  • PhD is a must
  • PhD in Organic Chemistry or Analytical Chemistry or equivalent, with a minimum of 5 years of relevant pharmaceutical/biotechnology experience.
  • In-depth experience with the analytical development of small molecules required; experience with polypeptides is desirable.
  • Hands-on experience in API method development and various analytical instrumentation (e.g. LC, GC, LC-MS, GC-MS, NMR).
  • Experience with outsourcing and suppliers management.
  • Excellent knowledge of chemical development process steps, from support to Research, to process optimization, scale up, and technology transfer to commercial manufacturing.
Preferred Skills/Qualifications
  • Practical Organic Chemistry knowledge
  • Excellent communication, negotiation and external follow-up
  • Excellent knowledge of analytical development process steps, from support to Research, to process optimization, scale up, and technology transfer to commercial manufacturing.
  • Excellent understanding of the management of chemical and physical quality of API through process design and optimization.
  • Practical experience in implementing the principles of Quality-by-Design.
  • Excellent knowledge of how to control API chemical and physical quality on scale up.
Excellent understanding of cGMP with emphasis on regulatory


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