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:
Areas of Responsibility:
- 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).
Accountabilities:
- 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.
Educational Background:
Doctorate Degree or its International Equivalent in Chemistry, Pharmaceutical Science, Biochemistry, Chemical Engineering or related field.
Skills/Experience:
- 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.
Supervision Given/Received:
- 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
Experience:
- 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.
Travel Requirements:
- Approximately 20%
Compensation/Benefits:
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.
Job Function:
Organization Info
Listing Stats
Post Date:
Dec 28 2018
Active Until:
Jan 28 2019
Hiring Organization:
Fhi 360
industry:
Nonprofit