Seeking a Principal Scientist CMC in Analytical Chemistry who will have expert skills in pharmaceutical analytical chemistry, clinical trial manufacturing and authoring of CMC sections of regulatory submissions. The Scientist will also possess a deep understanding of the pharmaceutical development process from pre-clinical development through life-cycle management.
Responsibilities: The selected candidate will be engaged with cross-functional teams seeking to develop new chemical entities in a variety of dosage forms; keep abreast of potential new technologies to enable the design of new products, update current products and enhance technical capabilities to support development activities; leverage existing technologies and resources to advance our core businesses; advance our characterization, testing, analysis, and clinical trial manufacturing capabilities; plan and lead CMC development projects from concept to manufacturing; collaborate in the evaluation and assessment of competitive products, processes and new trends to ensure compliance with quality policies, procedures, and practices through appropriate communication, training and education of sound quality assurance.
Analytical Chemistry: Actively lead and participate in activities to support the development of novel pharmaceutical dosage forms for the Infection Prevention Platform.
Conceive and develop technologies to advance business goals internally and through the identification of external collaborative opportunities.
Deliver new product solutions which offer differentiating value to the business, our customers, patients, and the environment.
Preclinical/Clinical Manufacturing: Actively lead and participate in Preclinical/Clinical Manufacturing activities to facilitate in vivo evaluations of developed drug products for the Infection Prevention Platform.
Responsible for solving advanced technical problems.
Plan, implement and monitor the delivery of designated products with accountability for projects success.
Regulatory Writing: Actively author and defend applicable CMC activities for products under development.
Technology Transfer: Work with in plant resources to implement and execute efficient and effective transitions of products from research & development to manufacturing.
Partnership: Identify, establish working relationships and leverage best in class product and internal and external technology development partners.
Process Effectiveness: Utilization of the scientific method to identify problems or potential risks and deliver quick, effective solutions to enable projects to meet their timing and deliverables.
Ensure appropriate processes are followed for effective and timely engagement of other parts of the company in product development activities.
Master’s degree, in Pharmacy, Chemistry, or other related field or an equivalent combination of education and experience with 8 or more years of related experience in the pharmaceutical industry.
Successful track record of developing and delivering to market commercially viable products.
Knowledge of analytical chemistry, chromatographic separations, method development and validation in the pharmaceutical industry is required along with a background in GMP manufacturing of commercial or clinical trial materials are highly desired.
MS (with 5-7 years industry experience) or PhD (with 3-5 years industry experience) in biology, microbiology, pharmacology or life-sciences-related field.
Demonstrated success in development and execution of preclinical and/or clinical studies to support product development and regulatory registrations.
Familiarity with global drug and/or device development processes
Experience working in an environment controlled by Good Laboratory Practice (GLP), Good Clinical Practice (GCP), and/or Good Documentation Practice (GDP) requirements.