Senior CMC Specialist

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Senior CMC Specialist


POSITION DESCRIPTION

Position           Senior CMC Specialist
Company        resTORbio, Inc.
Location         Cambridge, MA
Website           https://www.restorbio.com/


COMPANY BACKGROUND

resTORbio, Inc. (NASDAQ: TORC, $482M mkt cap) is a clinical-stage biopharmaceutical company focused on helping people live healthier longer through the development and commercialization of novel therapeutics for the treatment of aging-related diseases. resTORbio’s lead program is targeting the selective inhibition of TORC1 - an evolutionary conserved pathway that contributes to the decline in function of multiple organ systems, including the immune, cardiac and neurologic systems. resTORbio program has demonstrated in several clinical trials, including a randomized, placebo-controlled trial, the potential to treat multiple diseases of aging for which there are no approved therapies. RTB101, resTORbio’s lead drug candidate is a selective, orally administered, TORC1 inhibitor currently being tested in a Phase 2b clinical trial as a first in-class immunotherapy for reducing the incidence of respiratory tract infections in the elderly by enhancing the function of the immune system. The company expects to develop RTB101 for additional aging-related indications such as heart failure or neurodegenerative diseases.


KEY RESPONSIBILITIES

  • Participation in outsourced API and DP manufacturing processes
  • Participation in solving potential manufacturing processes challenges
  • Participation in oversight of manufacture of regulatory starting materials, intermediates and API in support of clinical trial material requirements and commercial process validation
  • Participation in ensuring that regulatory starting materials and API process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Participation in ensuring that DP process development and manufacturing activities are conducted in compliance with good manufacturing practices and applicable regulatory requirements by proactively co-overseeing process development and manufacturing campaigns
  • Review API and DP batch records, analytical methods validation plans, process validation plans and protocols, manufacturing campaign reports.
  • Contribute to CMC regulatory submission as a subject matter expert
  • Prepare technical reports, patent application content, publications and oral presentations as necessary
  • Communicate progress and strategy in various forums including reports, presentations and open discussions

PROFESSIONAL EXPERIENCE / QUALIFICATIONS

  • PhD in synthetic organic chemistry and or DP formulation development or Pharmacy degree and least 5 years’ experience in pharmaceutical industry or similar M.S. degree with at least 8 years of experience
  • In-depth knowledge of medicinal/synthetic organic chemistry, chemical process development,
  • DP formulation process development and efficient process throughput concept
  • Experience working in a virtual model setting is a plus
  • Proven track record of successfully overseeing API chemistry program and DP process development
  • Experience working with analytical and formulation development, quality assurance and control teams
  • Experience with contributing to CMC sections of clinical trial and marketing applications worldwide
  • Excellent interpersonal, verbal and written communication skills
  • Comfortable in a fast-paced environment and able to adjust based upon changing priorities

HIRING EXECUTIVE PROFILE

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Abdellah Sentissi
Head of CMC

Dr. Sentissi joined resTORbio as Head of CMC and Pharmaceutical Development in January 2017. Dr. Sentissi brings more than 30 years of experience leading manufacturing and quality functions for biotechnology companies. During his career working with several companies as a consultant or as functional leader, Dr. Sentissi led several products through scale-up, registration and validation runs, facility validation and all related quality assurance and control functions. Dr. Sentissi earned his Pharmacy degree from the School of Medicine and Pharmacy-University Paul Sabatier, Toulouse, France and a Ph.D. in Biomedical Sciences from Northeastern University. He also holds multiple French National Certifications in Medical Pathology, Immunology, Hematology and Parasitology from the School of Medicine and Pharmacy-University Paul Sabatier and the School of Pharmacy of Montpellier, France.

https://www.linkedin.com/in/abdellah-sentissi-43ba718/


TO APPLY PLEASE CONTACT A KLEIN HERSH REPRESENTATIVE

Jared Kaleck
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-9229
Email: jkaleck@kleinhersh.com


Marc Miller
Client Partner
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 215-830-0294
Email: mmiller@kleinhersh.com


Nicole Brueckman
Research Associate
220 Gibraltar Road, STE 150
Horsham, PA 19044
Phone: 267-948-1431
Email: nbrueckman@kleinhersh.com