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About the Role

The Formulation Specialist will assist the Formulation Scientist with hands-on formulation development and implementation of the GMP manufacturing process. They will also provide technical and scientific expertise in developing the formulation of those products which includes formulation strategies, various formulation prototypes, analytical method development and data analysis.

Responsibilities

• Hands-on development of various formulations such as injectables, gels, vaginal inserts and vaginal ring for sexual and reproductive health, including contraception alone and for Multipurpose Prevention Technologies (MPTs) to simultaneously prevent HIV, other sexually transmitted infections (STIs)
• Perform physico-chemical characterizations and pre-formulation work
• Establish the scale-up of the manufacturing process from prototype to lab scale
• Hands-on technical manufacturing and GMP manufacturing of drug products in a clean room facility
• Assist in the drafting and reviewing of the technical batch and GMP manufacturing batch records including certificate of analysis
• Establish bioburden or sterilization process, packaging and integrity testing of the packaged drug products
• Coordinate and monitor outside vendors for testing services
• Perform in-house testing which includes in vitro release rate testing, assay, and degradation of the active pharmaceutical ingredients
• Perform in-house stability studies on both technical and GMP drug products
• Assist in drafting & reviewing new analytical methods, manufacturing records, and data generated by the lab
• Understand and follow GMP SOPs and maintain GMP compliance
• Provide guidance, feedback and assistance to the lab staff with existing projects in the lab

Requirements

• Ph.D. in pharmaceutical sciences, chemical engineering, chemistry and related discipline with a focus on bench work and instrumentation
• Minimum 2-3 years of post-doctorate experience. Exceptional candidates with less experience will also be considered.
• Hands-on experience in carrying out experiments and data analysis
• Knowledge of how to perform design of experiments
• Computer skills with utilization of Microsoft Office (Outlook, Word, Excel, PowerPoint, etc.) required.
• Problem solving skills required, preferred experience with laboratory investigations
• Must be able to work autonomously and collaborate with the lab staff
• Highly self-motivated

Skills

• Formulation development
• GMP manufacturing process implementation
• Formulation strategies
• Formulation prototypes
• Analytical method development
• Data analysis
• Injectable formulation
• Gel formulation
• Vaginal insert formulation
• Vaginal ring formulation
• Physico-chemical characterizations
• Pre-formulation work
• Scale-up
• Clean room manufacturing
• Technical batch records
• GMP manufacturing batch records
• Certificate of analysis
• Bioburden process
• Sterilization process
• Packaging
• Integrity testing
• Vendor coordination
• In vitro release rate testing
• Assay
• Active pharmaceutical ingredient degradation
• Stability studies
• Analytical methods
• GMP SOPs
• Microsoft Office Suite

Location

• New York, NY

Work Type

• Indefinite Assignment

Experience Level

• 2-3 years post-doctorate experience

Education Level

• Ph.D.

Salary/Compensations

• $85,000-$95,000

Benefits

• Medical insurance
• Dental insurance
• Vision insurance
• Life insurance
• 403(b) retirement plan with employer contribution
• 24 annual days
• 12 sick days
• 10 paid holidays
• 13 weeks of paid parental leave
• Educational assistance
• College tuition support for dependents

About the Company

• The Population Council is an international, nonprofit, nongovernmental institution that seeks to improve the well-being and reproductive health of current and future generations around the world and to help achieve a humane, equitable, and sustainable balance between people and resources. The Council conducts biomedical, social science, and public health research and helps build research capacities in developing countries. Established in 1952, the Council is governed by an international board of trustees. Its New York headquarters supports a global network of country offices.

Equal Opportunity

• The Population Council provides equal opportunity; it does not discriminate against any person with regard to age, color, creed, national origin, disability, political belief, veteran status, religion, marital status, gender, gender identity, or sexual orientation. Decisions on employment are based on an individual’s qualifications as related to the position for which they are being considered. The Population Council is international in the composition of its board of trustees and its staff, as well as in the nature and deployment of its activities.