CambridgeRecruiter Since 2001
the smart solution for Cambridge jobs

Senior Director, Analytical Development

Company: Sana Biotechnology, Inc.
Location: Cambridge
Posted on: April 5, 2021

Job Description:

Sana is seeking an exceptional Senior Leader to join our dynamic and growing team supporting CMC development of novel gene and cell therapy drug substances and products.-- The Senior Leader of Analytical Development will oversee the establishment of analytical methods and their intensive application for product and process characterization in early development; by leveraging automation / high-throughput testing and data analysis. With a strong focus on both technical and operational excellence, this senior managerial position will play a leading role in shaping core technology platforms at Sana and the advancement of therapeutic gene and cell therapy candidates from Research into the clinic. This role represents an exciting and unique opportunity to shape the early CMC development paradigm for advance therapies. DUTIES AND RESPONSIBILITIES The experienced leader in this role will build a world-class capability with an expert analytical team to drive product and process understanding. The leader will manage assay establishment, automation, testing operations, and data analysis across a portfolio of technologies. The leader will partner closely with process and formulation development to guide strategy and manage analytical development in order to design quality into the Phase 1 CMC packages for novel gene and cell therapies. The individual will play a key role in building out the control strategy for Sana's investigational products, and also participate in cross-functional program teams. The successful candidate will have industrial experience managing an analytical development team for biologics/vaccines (and/or preferably gene/cell therapy), have a passion for delivering results and making an impact, an interest in technology and commitment to learning, and be an extraordinary collaborator in a dynamic setting. The ideal leader will shape strategy, build the capability, drive for operational excellence and continuous improvement, and manage a high-performing team.-- Responsibilities:--

  • Develop/oversee strategy for staged deployment of analytical methods and testing during early platform technology and CMC development. With innovation and pragmatism, accelerate the learning curve and long-term success of developing innovative new products by (1) supplying advanced analytical capabilities (with high volume and rapid turnaround time) to guide research & early CMC development, (2) enabling early and deep insights into quality attributes and process parameters, (3) critically informing the selection/optimization of product candidates, and (4) supporting the rapid translation of product candidates into the clinic.--
  • Build and manage a high-throughput / automated testing capability (non-GMP) to support CMC development of Sana's gene and cell therapy programs. Adapt methods for the throughput and technical demands of fast-paced early development programs. Assay families will include: biochemical, molecular biology (PCR, ddPCR), immunoassays (ELISA), cell-based (flow cytometry), and biophysical.
  • Hire and manage a team of scientists to develop, operationalize, and oversee analytical methods and their application in building product insight and solving complex process and formulation development challenges.
  • With a focus on technical excellence, the individual will oversee assay optimization, implementation, performance, troubleshooting, and analysis of results.
  • With a focus on operational excellence, the individual will oversee the design, delivery, and continuous improvement of sample and analytical data workflows to address the needs of the business from the standpoint of: turnaround time, testing capacity, quality, and cost.
  • Participate in establishment of drug substance and drug product specifications for IND, IMPD, and BLA submissions. Review/author protocols, reports, and analytical sections of regulatory submissions (IND, IMPD, BLA). QUALIFICATIONS Basic Qualifications
    • Bachelors plus 12+ yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a leader; has experience managing department(s) with mid level and senior employees.
    • Experience with the following methods /technologies: cellular, biochemical and molecular biological (PCR, ddPCR) methods, immunological methods (ELISA, MSD), spectroscopic and fluorescent methods, flow cytometry, HPLC, automated liquid handling, electronic notebooks.
    • Prior experience leading a team in Analytical method development, testing, QC, or stability is important for success in the position.
    • Must have exceptional organizational skills, preferably with advanced practical experience (+/-certification) in operational excellence or the management of complex workflows using Lean or Six Sigma.
    • Solid understanding of relevant regulatory agency guidance such as FDA, ICH and EMA and hand-on experience.
    • Ability to work in a fast-paced growth environment, and to prioritize work from multiple projects.
    • Demonstrates a respect for others and is open to new/different ideas.
    • Excellent written and verbal communication skills. Preferred Qualifications
      • Bachelors plus 15 yrs or equivalent combination of education and work experience; expert knowledge of principals and concepts and is a thought leader; has experience managing department(s) with senior employees.
      • Organizational leader with experience managing a team of direct (and indirect) reports in technical development of CMC (analytical, process, or formulation) packages for IND/CTA submission. Demonstrated track record, broad experience, and demonstrated success in analytical sciences for characterization of biological products, associated product-related species, and process residuals/impurities.

Keywords: Sana Biotechnology, Inc., Cambridge , Senior Director, Analytical Development, Executive , Cambridge, Massachusetts

Click here to apply!

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

I'm looking for
in category
within


Other Executive Jobs


Senior Clinical Project Manager
Description: Every day, Kelly Scientific Resources connects scientific professionals with opportunities to advance their careers, and we currently have a direct hire opening for an Senior Clinical Project Manager (more...)
Company: Kelly Services
Location: Weymouth
Posted on: 04/12/2021

Sr Manager Advanced Manufacturing Engineering
Description: Sr Manager Advanced Manufacturing Engineering Plymouth, MI JOB DESCRIPTIONSummary: Understand current production polyurethane chemistry throughout North America and provide support to all locations. Develop (more...)
Company: Adient plc
Location: Plymouth
Posted on: 04/12/2021

Senior Manager, Quality Assurance and Regulatory Affairs
Description: Senior Manager, Quality Assurance and Regulatory Affairs Plymouth, MN At Integer, our vision and values are embedded in everything we do -- If you want to work for an organization that values customer (more...)
Company: Integer Holdings Corporation
Location: Plymouth
Posted on: 04/12/2021


Manager, Claims & Fraud Operations, Card Claims, East Providence, RI
Description: The Manager, Claims Fraud Operations leads a team responsible for efforts to detect, prevent and mitigate fraud risks and losses, maximize fraud loss recoveries, and manage the effective and timely (more...)
Company: Santander Holdings USA Inc
Location: East Providence
Posted on: 04/12/2021

Project Execution Support Director
Description: Cabot Corporation - Careers - Project Execution Support Director in Billerica, Massachusetts - Careers at Billerica Business Center Skip to Main Content Please Enable Cookies to Continue Please enable (more...)
Company: Cabot Corporation
Location: Billerica
Posted on: 04/12/2021

Associate Dir, Offering Management
Description: Primary Location: Plymouth Meeting, Pennsylvania, United States Full time R1195979 Date Posted: 03/22/2021 Essential Functions ul li Assist in the development of best class capabilities, offerings (more...)
Company: IQVIA Argentina
Location: Plymouth
Posted on: 04/12/2021

Server/Dining Room Care Manager
Description: Overview br It makes me feel good knowing that we make the residents' lives better. We laugh with them, cry with them, sing and dance with them - we brighten their day. Working here is an unbelievable (more...)
Company: Sunrise Senior Living
Location: Plymouth
Posted on: 04/12/2021

Assistant Manager D'Angelo's
Description: Description br br Be an Addition by SUB-Attraction br br At D'Angelo's Grilled Sandwiches we are looking for happy people who care about making a difference by creating an atmosphere where passion (more...)
Company: D'Angelo's
Location: Concord
Posted on: 04/12/2021

Accounting Manager
Description: Accounting Manager The Opportunity We're looking for an Accounting Manager, working in the Real Estate industry in Boston. Ensures accuracy of property rent rolls, financial reports, budgets and re-projections. (more...)
Company: Professional Staffing Group
Location: Salem
Posted on: 04/12/2021

Travel Registered Nurse RN Manager
Description: Nurse Managers help patients by managing the nurses who care for them. While these nurses are mainly responsible for recruitment and retention of the nursing staff
Company: OneStaff Medical
Location: Salem
Posted on: 04/12/2021

Log In or Create An Account

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

Cambridge RSS job feeds