Danuta Gromek-Woods, Ph.D. Email & Phone Number

Provided a Chemistry, Manufacturing, and Controls (CMC) Subject Matter Expert technical, strategic, and regulatory guidance to pharmaceutical companies. Responsible for leveraging scientific and regulatory CMC expertise to support clients through the various phases of drug development while working closely with a multi-disciplinary team to ensure solutions are comprehensive and tailored to each client’s unique needs. Responsibilities included supporting clients in formulation development, advising on regulatory requirements at each stage of pharmaceutical development, authoring CMC regulatory submissions, providing scientific and regulatory support on drug substance and drug product quality expectations and development of proper control strategies, with specific expertise in small molecule and botanical drug products.

Provides a full range of consulting services and works within quality of pharmaceuticals in the pre-marketing and post-marketing areas, with specific expertise in small molecules drug products.Acts as a trusted advisor to clients, often on complex issues in the area that require extensive interpretation and resolution to complex regulatory and scientific issues that often lack precedent or are not clearly defined. As part of the Regulatory Consulting Services group, implements knowledge-centered activities, innovate methodologies and service offerings to expand PAREXEL’s global regulatory and compliance consulting services.Develops and implements business solutions addressing specific client needs using expertise, best practices and knowledge of the client’s business and key industry driver.

• Assessment of pharmaceutical quality of drug products in pre-marketing and post-marketing regulatory applications (INDs, NDAs and sNDAs)• Senior Pharmaceutical Quality assessor on inter-disciplinary Review Team conducting evaluation of critical quality attributes and identifying, communicating, and resolving approvability issues• CMC Team Leader/Application Technical Lead; leading approvability and marketing of products for patients in need• Representing the office/center/agency as the CMC technical authority during the meetings on regulatory submissions with sponsors/applicants from the regulated industry• Led team of scientists for Office of Testing and Research projects pertaining to drug product quality and reverse engineering of brand products

• Worked with the President, Vice Presidents, and Directors to build a strong contract research organization and to identify and build relationships with external customers• Worked on technical development and staffing of the Analytical R&D Department• Worked on the organization and processes within Analytical R&D to ensure that the analytical method development and validation are seamless• Managed analytical method development, validation, and reverse engineering of brand products• Coordinated multi-disciplinary CMC projects to assure that they are completed within specified timelines and budget while meeting all quality and regulatory requirements

Established and organized the Pre-formulation Department – new instrument implementation and qualification, development of the SOPs, hiring scientists, implementation of pre-formulation functional operations and associated administrative activities. f• Oversaw the overall operations of pre-formulation functions reporting to this position (pre-stability studies, solubility, determination of pKa, partition coefficient, chemical stability profile, active/excipient compatibility, crystal properties and polymorphism, particle size shape and surface area, and other physico-chemical characterization of API, excipients, and formulations), supported the Formulation Department in designing an optimum delivery system• Interact with Stiefel Pharmaceutical Science Divisions on a global levelCore Team Member of the Global Development Project for an (NME): managed the chemistry section of the pharmaceutical development for the topical formulation, supervised bio-analytical method development, validation, and clinical material analysis, cooperated with scientists from other Stiefel subsidiaries worldwide in solving complex analytical and formulation development problems• Supervised analytical method development and validation. This included the isolation, purification, mass balance studies and characterization of potential degradation products• Conducted reverse engineering of brand products, provided support for the formulation department• Implemented new instrumentation, conducted training of other scientists in advanced chromatographic techniques

• Performed extraction, isolation,purification, and structure determination of biologically active natural products (Annonaceous acetogenins) by various chromatographic and spectroscopic methods• Developed and implemented new methods of quantitative analysis of acetogenins by HPLC• Studied the biogenesis of acetogenins by biomimetic synthesis from their natural precursors• Performed cytotoxicity studies of extracts and isolated compounds in vitro• Trained and advised undergraduate and graduate students

Doctor Of Philosophy - Phd, Pharmaceutical Sciences

Master'S Degree, Pharmacy