Pharmaceutical Formulation Chemist
Watertown, MA /
Are you interested in an engaging job and making a big impact in patient's lives?
Windgap Medical, Inc. is a rapidly-growing, private pharmaceutical company developing injection devices for self-administration and associated drugs and is based out of Watertown, MA. Windgap’s first product is a wet/dry autoinjector delivering a proprietary epinephrine formulation for the treatment of anaphylactic shock. Windgap will leverage its injection platforms, formulation, and manufacturing expertise for additional indications.
Windgap is looking for a hands-on Pharmaceutical Formulation Chemist to develop safe, effective formulations optimized for integration into its proprietary primary drug container. The candidate will be joining Windgap’s Operations team to support the development new products from concept to commercialization in support of company growth. The position will also enhance and improve upon current products. The position will serve as a technical expert that supports product improvements, quality improvements, customer requests, and cost savings initiatives. The candidate preferably has hands-on experience with powder handling, suspension and liquid filling, and parenteral drug manufacturing. Experience with drug/device combinations products is a significant plus. Preference will be given to candidates that demonstrate experience with parenteral products, however, candidates that have experience with the filling of inhalation devices, or other drug/device combinations, should apply.
Department and Reporting Relationship:
· Department: Operations
· Reports to Vice President of Operations
The candidate will:
- report to Windgap’s VP of Operations as part of matrixed organization supporting product development
- be capable of working both independently and in a team, while being flexible, self-motivated, curious and willing to drive change
- contribute to the commercialization of Windgap’s wet/dry autoinjector through the ownership of chemistry, manufacturing, and controls
- design and execute formulation development experiments to develop and support rapidly dissolving parenteral formulations.
- design multivariate studies of different formulations of a particular product, minimizing the number of replicates while maximizing the amount of information obtained
- conduct physicochemical characterization of different drug substances and drug products
- conduct studies on long-term stability of products
- analyze results of experimental studies and write reports for both corporate records and regulatory bodies
- assist with scale-up from development to production quantities, in collaboration with chemical engineers and plant production personnel
- work closely with the Windgap’s CMOs to develop an integrated drug/device combination filling process. This includes but is not limited to: powder micronization, suspension filling and processing, liquid filling, powder filling, drying and environmental control, vacuum stoppering, aseptic and terminal processing, handling high-potency compounds, and quality control and analytical testing
- define process instructions, and release specifications
- work collaboratively on a joint development team with Windgap’s licensing partners
- work with the Watertown-based R&D team for the fill/finish development of multiple drug products
- B.S. is required, in addition to 10+ years of formulations drug product development experience (or MS with 8+ years, or PhD, with 4+ years of relevant experience). Minimum of 4 years of working experience developing and testing pharmaceutical formulations
- Confident laboratory skills, especially in analytical techniques for product analysis
- Analytical mindset on formulation, and hands-on experience with instruments such as HPLC, UV spectroscopy, dissolution, microscopy
- Knowledge in discovery and preclinical formulation, pre-formulation screening, solid state characterization and aiding formulation design.
- Math and statistical skills for complex experimental design and analysis such as Design of Experiments, ANOVA, and other techniques
- Experience operating in a regulated environment, with understanding of 21 CFR 4, 210, 211, and 820
- Preferably, experience with micronization, suspension filling, powder filling and handling
- Preferably, experience filling parenteral and injectable-related products
- Preferably, experience in a highly virtualized organizations while successfully engaging and managing external resources, worldwide
- Experience with MS Office, including email, word processing, spreadsheets, project management and presentation tools
- Experience with statistical analysis tools, such as Minitab or JMP, to support analysis techniques like Student’s T-test, ANOVA, and DOE
Windgap Medical, Inc. offers a competitive benefits package including, medical, dental, disability, life insurance, 401K savings plan and is EOE/M/F/D/V employer. In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and to complete the required employment eligibility verification document form upon hire.
Thank you for considering Windgap Medical. We will review your qualifications and contact you if we would like to talk more.
The Windgap Medical Team