CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Director, Cell Therapy Process Engineering

Company: Semma Therapeutics Inc
Location: Cambridge
Posted on: October 17, 2020

Job Description:

Job Description In June 2019, Vertex announced the establishment of a new research site in the Boston area where research, development, and clinical manufacturing for cell and genetic therapies will be primarily based. Cell and genetic therapies represent two rapidly emerging therapeutic modalities with the potential to treat--and even cure--several of the diseases Vertex is focused on, including sickle cell disease, Duchenne muscular dystrophy and type 1 diabetes. Further investment in a research site specifically designed to advance these programs will be key to Vertex's continued and sustained leadership in these exciting approaches. At Vertex Cell and Genetic Therapies (VCGT) our research teams will bring together the best biology, technologies and enhanced manufacturing capabilities to ensure we bring these cutting-edge transformative therapies to patients as quickly as possible. Vertex, a biopharmaceutical company focused on developing a cell and gene-based therapies for multiple indications, is seeking a Director of Cell Therapy Process Engineering/Development to join its growing team. The full-time role will be responsible for oversight of Vertex's cell therapy process development laboratories and will oversee the efforts Process Development/Engineering staff. This role will work closely with the leadership team, research, supply chain, delivery device, preclinical, and quality teams to meet program milestones. The position will be based in Cambridge MA and Boston, MA. This individual will be responsible for developing and executing the overall Process Engineering strategy relating to design and development of a novel cell therapy for the treatment of Type 1 Diabetes. In addition, he / she will provide cross-functional leadership in overseeing development, technology transfer, and validation of all processes, from Research and Development into Manufacturing, as the Company prepares to begin clinical development. In addition, he / she will plan and implement continuous improvement initiatives, scale up operations and downstream processing methods. This person will serve as the technical lead for the project. It is also expected that the incumbent will provide support to other groups, including R&D and manufacturing, as required. Responsibilities: * Develop Process Development strategy including short and long term deliverables/milestones, and lead Process Engineering initiatives and manage Process Engineering Resources to achieve Technical Operations Objectives. Will have responsibility for hands on development of processes relating T1D cell therapy production. * Work independently and with the team to develop scaled process through clinical and into commercial manufacturing that will meet clinical demand * Manage the execution of deliverables, both short and long-term, via clearly defined milestones, and minimize timeline deviations by clearly identifying program risks and communication of strategies * Establish robust process performance across all clinical and commercial manufacturing lines, including process development, process improvement, and maintenance of process excellence. Lead process monitoring, continuous improvement, and lifecycle management initiatives. Establish K.P.Is. and manage performance gaps. * Ensure timely completion of activities needed for Investigational New Drug (IND) applications with the US Food and Drug Administration (FDA). Supports the filing activities as needed. * Identify possible CDMO partners and lead technology transfers, oversee the performance, quality and delivery of external collaborators * Build and develop a high-performing process engineering team, including management, ensuring the right skills are added at the appropriate time during periods of rapid growth. * Foster an inclusive, collaborative, transparent, engaged and accountable culture. Coach team for positive inter-departmental collaboration * Responsible for establishing the budget and maintaining control of costs * Drive continuous improvement activities and operational excellence, including reduction of Cost of Goods Sold (COGS) and commercial readiness ? Required Qualifications: * PhD in Life Sciences, bio-engineering, or related discipline with minimum 8 years of relevant industrial work experience or Master's degree with 12 years of industry experience * 3-5 years management experience preferred * 5+ years of demonstrated process development experience in a bio-pharmaceutical setting working with interdisciplinary and cross-cultural teams * Experience working with cell processing devices and bioreactors * Ability to communicate effectively with a diverse range of scientists, engineers, regulatory specialists and business professionals * Proven experience with Process Development, Process Technology Transfer, Technical Operations, and Lifecycle Management. * Experience validating manufacturing processes is required. Knowledge and experience of utilizing risk-based approaches to validation process development

Keywords: Semma Therapeutics Inc, Cambridge , Director, Cell Therapy Process Engineering, Other , Cambridge, Massachusetts

Click here to apply!

Didn't find what you're looking for? Search again!

I'm looking for
in category
within


Other Other Jobs


Earn more this Fall, deliver with Uber Eats
Description: 38 quot 10 Deliver with Uber. Earn on your schedule. 10 Work on your schedule. Deliver for a few hours in the mornings, every night, or just on weekendsit 38 039 s up to you. 10 Earn Good Money. (more...)
Company: Uber Eats
Location: Concord
Posted on: 10/25/2020

Sunoco Sales Associate
Description: ESSENTIAL JOB DUTIES AND RESPONSIBILITIES: Customer Service Running a cash register, this includes accountability for cash, lottery tickets, cash
Company: Dunkin'
Location: East Providence
Posted on: 10/25/2020

CDL A Local Truck Driver - Dedicated Home Daily
Description: Join the Cowan Family as a dedicated local driver out of Uxbridge, MA. Our drivers on this account make between 57,000 and 63,000 per year. You'll enjoy our newly increased pay packages with a variety (more...)
Company: Cowan Systems
Location: East Providence
Posted on: 10/25/2020


Registered Nurse - Home Care (Position Eligible for $5K Sign On Bonus)
Description: HopeHealth is seeking an experiencedRegistered Nurse for its affiliate HopeHealth Visiting Nurse. In this role you will visitpatients in their homes within a specific geographic area. Position is eligible (more...)
Company: HopeHealth
Location: East Providence
Posted on: 10/25/2020

Regional CDL A Dry Van Truck Driver - Earn up to $.70 per mile
Description: Logistics One is Hiring Regional CDL A Truck Drivers. Top Drivers Earning over 70,000 Per Year Drivers can be home every week or stay out longer, you decide Guaranteed minimum
Company: Logistics One
Location: East Providence
Posted on: 10/25/2020

OTR CDL A Lease Purchase Driver - $1,000 Guaranteed Weekly Pay - Great Home Time
Description: LEASE PURCHASE CDL-A TRUCK DRIVERS - OWN YOUR TRUCK IN AS LITTLE AS 12 MONTHS ASK ONE OF OUR RECRUITERS ABOUT OUR NEW SETTLEMENT PLUS PROGRAM- 1,000 Weekly Pay Guarantee CDL- Lease Purchase Opportunities (more...)
Company: Risinger Brothers Transfer
Location: East Providence
Posted on: 10/25/2020

Production Support Services, Advisor
Description: Position SummaryAs an Advisor,Production Supt Svcs, you will responsible for maintaining and supporting critical CVS Health Pharmacy systems and applications. You will be involved with event, incident, (more...)
Company: CVS Health
Location: Woonsocket
Posted on: 10/25/2020

Personal shopper - get paid to grocery shop
Description: Shipt is a membership-based marketplace that helps people get the things they need, like fresh produce and household essentials, from stores they trust. Help people save time and have fun while you're (more...)
Company: Shipt
Location: Concord
Posted on: 10/25/2020

Amazon Warehouse Assistant (with $1500 sign on Bonus + Benefits)
Description: Job Description Warehouse Associate - 1500 Sign-On Bonus Hourly pay rate: 16.50 - 19.50 plus a 1500 bonus The base pay for this role is 16.50/hr. Earn 3/hr extra for the 2:30am or 3:30am shifts (more...)
Company: Amazon
Location: Woonsocket
Posted on: 10/25/2020

CDL A Local Truck Driver - Dedicated Home Daily
Description: Join the Cowan Family as a dedicated local driver out of Uxbridge, MA. Our drivers on this account make between 57,000 and 63,000 per year. You'll enjoy our newly increased pay packages with a variety (more...)
Company: Cowan Systems
Location: Woonsocket
Posted on: 10/25/2020

Log In or Create An Account

Get the latest Massachusetts jobs by following @recnetMA on Twitter!

Cambridge RSS job feeds