US or UK
Satsuma Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic for the acute treatment of migraine. Our lead drug candidate, STS101, is a drug-device combination of a proprietary dry-powder formulation of dihydroergotamine mesylate, or DHE, capable of being quickly and easily self-administered by a proprietary pre-filled, single-use, nasal delivery device. STS101 is currently in Phase 3 development.
This newly developed role of Project Engineering Manager will report to the Director of Manufacturing. The role is in the pharmaceutical industry, based in the UK or US, working with equipment suppliers, suppliers of packaging materials and components liaising with Contract Manufacturing Organizations to establish commercial-scale packaging capability for a new single-use, dry powder, nasal delivery drug/device combination product.
This role can be either direct hire or on contract.
Duties and Responsibilities:
- Responsible for the delivery of the commercial packaging line, including FMEA, FAT, SAT and validation at the CMO.
- Responsible for the development of commercial scale supply of packaging components from a variety of packaging material suppliers.
- Work with our supply chain manager to ensure capacities and packaging component supplies are adequate for development and commercial demand.
- Support CMOs to improve OEE for both manufacturing and packaging equipment.
Minimum Requirements Education/Experience:
- Bachelor’s degree in engineering, or similar field.
- Minimum of 7 years’ experience pharmaceutical industry process/equipment engineering, project management, operations, or similar role.
- Experience in project execution and program management.
- Experience in process development in a GMP setting, from early-stage development to commercial manufacture.
- Experience supporting commercial production in a GMP setting.
- Track record of developing and working with external suppliers including CMOs.
- Lean manufacturing experience desired.
- Strong analytical problem-solving skills a must.
- Excellent communication skills, with an ability to work in cross-functional teams including across multiple sites.
- Must be self-motivated have ability to work on own initiative.
- Strong quality orientation with attention to detail.
- Ability to identify problems and to be innovative and effective in developing solutions, mitigating execution risk.
- Collaborative leader with ability to strongly influence with or without authority, facilitate groups with diverse perspectives, and bring teams to consensus/alignment.
- High tolerance for ambiguity and change – able to create order from chaos.
- Takes accountability for actions, drives results, learns from mistakes; is direct and truthful and therefore widely trusted – delivers on promises, goals, and expectations.
- Makes quality decisions and resolves problems rapidly.
- Ability to communicate effectively at all levels of the organization.
- Excellent planning and prioritization, with an ability to multitask and adapt – able to synthesize large amount of information and deliver results despite shifting environment.
For additional information:
Please send your resume or CV to us at firstname.lastname@example.org