Senior Drug Process Scientist/Engineer
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. Windgap’s first product is a wet/dry autoinjector delivering a proprietary epinephrine formulation for the treatment of anaphylactic shock. Long-term, Windgap will leverage its injection platform for other therapeutic areas.
Windgap is looking for a hands-on Senior Drug Process Scientist/Engineer to support the effective and efficient development, qualification and validation of the company’s drug fill/finish process. The candidate will be joining Windgap’s Operations team to develop, optimize, and oversee all technical functions of company’s drug Chemistry, Manufacturing, and Controls (CMC) processes through process qualification, process validation and product launch. The candidate should have direct experience with powder filling, 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.
Windgap leverages a team of Contract Manufacturing Organizations (CMOs) for all manufacturing operations along with Contract Research Organizations (CROs) for much of its development support. The candidate should be a flexible, self-starter, who is effective in working with contract resources, coming to and executing on technical decisions in fast moving environments. The candidate should be comfortable investigating, in the lab, to assess process parameters and work to transfer those processes to the company’s CMO. While the position will be based in Watertown, MA there will be extensive travel (up to 50%) to the UK where the company’s filling CMO is currently located along with other vendors in the EU.
The candidate will:
- Report to Windgap’s VP of Operations for drug CMC development
- Contribute to the commercialization of Windgap’s wet/dry autoinjector through the ownership of filling chemistry, manufacturing, and controls
- Work closely with the Windgap’s filling CMO to develop an integrated drug/device combination filling process. This includes but is not limited to:
- Powder micronization
- Multi-component powder blending and processing
- Powder filling
- Liquid filling
- Vacuum stoppering
- Quality control and analytical testing
- Work to define critical process controls, process SOPs, and release specifications
- Work alongside the company’s Director of Quality in support of documentation drafting, execution, and sign-off
- 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 other drug products
- Provide hands-on, troubleshooting, process and manufacturing support as well as tech transfer in a fast-paced environment
- Establish individual and team goals consistent with overall project and company goals, working with CMO’s to enable
- Support reliability, testing, and manufacturing engineers as the product advances from early development to product maturity
- Be capable of working both independently and in a team, while being flexible, self-motivated, curious and willing to drive change in the drug delivery market
- BS in Chem, Chem Eng, BME or similar required, MS preferred
- Minimum of 5 years of working experience in pharmaceutical powder filling for combination products
- Knowledgeable of commercial powder and liquid filling technologies and commercial solutions for the pharmaceutical industry
- Preferably hands-on experience with small dose powder filling
- Successfully implemented blending and related processes for multi-component powder formulations
- Proven experience with micronization, high shear blending, and roller compaction and other powder processing methods
- Experience with 21 CFR 4, 210, 211, and 820
- Experienced with risk management in CMC
- Experience filling combination medical device component technologies such as syringes, cartridges, capsules, blisters, etc.
- Comfortable with all phases of product development lifecycle including concept generation, design, process optimization, manufacturing, verification & validation, qualification, PPQ and transfer to production
- Preferably, experience with particle engineering
- Preferably, experience filling parenteral and injectable-related products
- Preferable, experience in a highly virtualized organizations while successfully engaging and managing external resources, worldwide
- Preferably, comfortable with concepts of design input, design output, traceability, and risk analysis
- Experience with MS Office, including email, word processing, spreadsheets, project management and presentation tools
- Significant travel may be required
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