FHI 360’s Contraceptive Technology Innovation team leads development and testing of a portfolio of new contraceptive leads with a focus on long-acting methods. The team consists of 30+ contraceptive development professionals with expertise in reproductive biology, gynecology, chemistry, epidemiology, and clinical trial and project management. We are currently seeking qualified candidates for the position of: Director, Chemistry, Manufacturing and Controls (CMC)
Responsible for providing strategic and technical direction and oversight in support of FHI 360’s current and future contraceptive product development pipeline, which includes drug and drug-device combinations. Leads efforts to:
Evaluate technology options and partner capabilities for new projects involving long-acting or complex drug delivery platforms; including polymer based systems
Liaise with product development partners on formulation and/or device development, as well as manufacturing and regulatory requirements, to ensure compliance with US and International Regulatory Authorities;
Identify manufacturing pathways for product development partners to promote efficient progression from proof-of-concept through pilot production and scale-up;
Work with the partnership management team to identify and vet potential manufacturing partners;
Contribute to global knowledge through publication and attendance at conferences;
Act as a spokesperson for all aspects of product development, manufacturing and testing of contraceptive products in development and advise executive management;
Interface with various FHI 360 departments and serve as an internal consultant.
Serve as a key member of integrated product development team(s).
Develops and executes strategies for manufacturing of contraceptive products including but not limited to formulation and/or device development, process development, identification of appropriate test methods and specifications to assure product quality, manufacturing, process validation, and compliance.
Provides guidance and assistance to development partners regarding strategies associated with drug/device development and manufacturing processes (both pilot and scale up).
Interacts with subject matter experts and regulatory authorities, as required, including preparation for and attendance at meetings and teleconferences to advance research objectives.
Proactively identifies potential issues, analyzes options, and provides recommendations to internal and external teams.
Where possible, documents, facilitates and shares “lessons learned” across the individual product development activities.
Contributes to the definition of go/no-go criteria for product leads and assists in pipeline prioritization.
Serves as a catalyst for innovation through the generation of practical, sustainable and creative options to solve problems and create business opportunities, while maximizing efficient use of existing resources.
Performs other duties as assigned.
Applied Knowledge & Skills:
Demonstrates a strong knowledge of pharmaceutical processes and process development, with a focus on long-acting and other advanced drug delivery technology-based products, as well as expert knowledge and understanding of relevant experimental designs/strategies, operations, products, and services including interactions, communications with and management of third party sites, vendors, and related resources.
Possesses a thorough knowledge of applicable regulatory requirements for drug substance, drug product and device development; i.e., Good Manufacturing Practice (GMP) and International Conference on Harmonization (ICH) guidelines.
Must be able to read, write and speak fluent English. Mandarin a plus.
Supervises a team of senior scientists and scientists leading product development programs.
Provides suggestions to strategic, operational and business decisions that affect the department.
Builds working relationships internally and externally with other scientists and scientific community.
Reports to the Director of Research & Development
Doctorate Degree or its International Equivalent in Chemistry, Pharmaceutical Science, Biochemistry, Chemical Engineering or related field.
A minimum of 10 - 15 years of product development experience, Quality Assurance (QA)/Quality Control (QC), and/or manufacturing is typically required.
Demonstrated experience commensurate with this position’s expectations working as a CMC professional in pharmaceutical product development or manufacturing setting is required.
Experience with diverse drug delivery platforms, drug/device combination products, and sterile products is required.
Experience in both early and late stage product development is required, and commercialization experience for advanced drug delivery technology-based products is strongly preferred.
Experience working with contraceptive products preferred.
Direct supervisory experience of technical staff, preferably experience leading a team is required.
This job description summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.
FHI 360 fosters the strength and health of its workforce through a competitive benefits package, professional development and policies and programs that support healthy work/life balance. Join our global workforce to make a positive difference for others — and yourself.
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FHI 360 is an equal employment and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, disability, veteran status, genetic information or any other status or characteristic protected under applicable law.
FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing — creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.
As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.