We are ONE.
We, TOGETHER, are Sigilon.
We care deeply about patients’ and caregivers’ struggles, stories, and triumphs.
We care about rigorous science addressing critical patient needs
We strive to earn and keep the trust of patients, caregivers, and partners.
We respect each other, embrace diversity, and work as one team.
We are passionate about the impact of groundbreaking discoveries.
We dream big and don’t fear failure. We ask “What if we could…?”
We build value for patients and their families, clinicians, partners, and shareholders.
We make sure every experiment and decision counts.
We visualize success and make it happen.
We operate with urgency; patients can’t wait.
We are change-makers, and we never stop in our quest to advance therapies for patients in need. For us that takes a number of forms — we stay abreast of the most recent Sigilon science at our Sigilon Monthly Sessions, where a team member presents their findings and cross-pollination of ideas is encouraged; we also meet up informally, around the weekly Friday breakfast or in our collaboration hubs outside the lab. In this way, we’re always inspiring one another and advancing science that matters.
Never Losing Sight of Our Purpose
We’re at Sigilon to make a difference for patients, and that is front and center in our day to day work. We host patients and caregivers at our offices to learn more about the disease areas we aim to treat. And we stay engaged with the broader community, from organizing a fundraiser to send young people to the New England Hemophilia Association Family Camp, to sponsoring rare disease awareness efforts.
Enjoying Our Relationships
From our Sigilon running team to occasional yoga outings to escape rooms and offsite retreats, we really enjoy our teamwork in all forms. We are a close-knit team with an upbeat atmosphere, and it shows in our productive science — a true team effort.
Life at Sigilon
We have an amazingly collaborative team; we really like each other and this makes working together enjoyable.
Office Manager/Executive Assistant
I love that we have a fast-paced scientific workplace but where people are so approachable and friendly.
Sigilon Therapeutics is seeking an individual with broad expertise in external manufacturing, excellent communication skills, and the ability to work in a highly interactive and matrixed environment. The incumbent will oversee Contract Manufacturing Organizations (CMOs) for MCB, Cell Expansion, and Sigilon’s Shielded Living Therapeutics™ encapsulation, and labeling; including managing the business relationship, negotiating contracts, ensuring the successful CMO supply of product, and achieving operational and business goals. The successful candidate will also assist in managing distribution between CMOs. This role will require daily interaction with stakeholders including but not limited to Regulatory, Quality, TechOps (Manufacturing, Supply Chain, Process Chemistry, Device & Delivery Engineering, CMC Analytics, Materials Engineering, etc). Presentation of written and oral summaries of progress in team meetings as well as to management is expected. This employee will operate a diverse array of development, manufacturing, and analytical equipment and maintain a safe laboratory environment.
- Oversee and manage the relationship of CMOs for MCB, Cell Expansion, and Sigilon’s Shielded Living Therapeutics™ encapsulation, and labeling; including but not limited to:
Participates and contributes in CMO selections and evaluates a CMO’s capacity and capability as an input to a sourcing decision. Supports Quality and TechOps on vendor qualification activities
Managing contract setup, negotiation, and maintenance (in collaboration with TechOps, Quality, and Legal)
Manage budget and ongoing spend for contracted activities
Establish and lead Quarterly Business Reviews and monitor and report performance according to KPIs
Facilitate regular project meetings with CMOs and internal stakeholders (TechOps, Quality, Project Management)
Managing and solving potential disagreements, contract breaches etc. (in collaboration with TechOps, Quality, and Legal)
Ensure processes between Sigilon and CMOs are functional and efficient
- Create and oversee CMO level supply plans and production schedules (e.g. capacity, forecast, material inventory) to deliver timely product. Identifies supply constraints and leads timely resolution of issues. Monitor schedule adherence of product schedules and make course corrections if needed
- Ensure effective communication and coordination between CMOs and stakeholders (e.g. TechOps, Quality, Project Management) so that product/project needs for tech transfer, cGMP manufacturing, and decommissioning are defined and met
- Support the investigation of exceptions and determine root causes, implement CAPAs and drive to closure. Follow-up of change control ton ensure timely implementation in line with regulatory and stock management constraints
- Oversee labeling activities at CMOs and ensure labels are in compliance to regulations
- Coordinate product and material shipment between CMOs. Acts as backup for shipments from CMO to clinical sites
- Ensure Product Security requirements at CMOs are implemented and maintained
- Develop supply strategies to maximize supply efficiency, while identifying risk and developing risk mitigation plans
- Lead cross functional projects and process improvements related to Supply Chain
- Assist in the creation and maintenance of Standard Operating Procedures
- Additional responsibilities as required
- BS in the relevant Engineering, Science, or related field is required with minimum 6 years biotech/pharmaceutical cGMP manufacturing experience. An advanced degree (MBA, MS, or PhD) is preferred
- Certification in Project Management (e.g. PMI certification) and process improvement methodologies (e.g. Six Sigma) is a plus
- Must have prior experience and proficiency in biologics/sterile manufacturing, and a proven track record solving complex technical issues. Experience across the cell therapy supply chain preferred
- Demonstrated project leadership skills and ability to develop effective working processes and relationships with internal/external partners and cross-functional project teams
- Understand comprehensive global pharmaceutical regulatory requirements (e.g. cGMP, GDP, CFRs, Annex 13, etc). Knowledge of product security programs
- Experience in interacting with Health Authorities (e.g. inspections)
- Experience in deviation investigation and CAPA implementation
- Strong negotiation skills
- Possess a strong attention to detail and have exceptional interpersonal, organizational and communication skills
- An energetic self-starter who is adept at multi-tasking, has a track record of productivity and capable of working both independently and as part of multiple collaborative teams
- Ability to prioritize responsibilities to meet project deadlines and flexibility to react quickly to changing research needs
- Travel up to 50%