Senior/Principal Design Quality Engineer

Location: 

RTP North Carolina or remote

Overview:

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.

Purpose:

This is a senior level position that is responsible for the quality oversight of design control and risk management activities for drug/device combination products.

This individual will work closely with the device development team, CMC team, and medical device suppliers and testing partners during the device design/development phases and include supportive responsibilities throughout the device lifecycle.

In addition, this role will provide oversight for the development, implementation, and continuous improvement of device-related quality processes and procedures and ensure compliance to the relevant standards and regulatory requirements for devices and combination products.

Duties and Responsibilities:

  • Lead Quality Engineering guidance and oversight for medical device and combination products during feasibility, all phases of design control, risk management, human factor/usability engineering, process development and verification/validation testing, as well as lifecycle management during design changes.
  • Lead device development team to define critical to quality characteristics for device components and finished devices.
  • Lead Quality review and approval of all technical documentation for design and development technical and risk management documentation, e.g., planning, traceability matrix, protocols, reports, risk assessments, testing, etc. by applying applicable company procedures, standards, and regulatory requirements.
  • Support IND, NDA, and post-Approval changes through authoring and/or reviewing sections of filing applicable to design control, risk management and specification and supporting responses to regulatory questions.
  • Support the timely handling of investigations, impact assessment, deviations, and CAPAs.
  • Function as the Quality representative on cross-function initiatives and device development programs.
  • Manage QA interface with medical device or device component suppliers and testing partner by providing technical and quality support during the development, testing and manufacture at a supplier site.
  • Prepare and manage development quality agreements. Support internal and external audits and inspections as a device or combination product Subject Matter Expert.

Minimum Requirements Education/Experience:

  • BS degree in engineering, or similar field.
  • Minimum of 7 years’ relevant industry experience.
  • Experience in project execution and program management.
  • Experience in Drug/Device Combination product development in a GMP setting, from early-stage development to commercial manufacture. 
  • Track record of developing and working with external partners.

Behaviors/Skills:

  • 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 a shifting environment.

For additional information:

Please send your resume or CV to us at careers@satsumarx.com

Director, Analytical

Location:

RTP North Carolina or remote

Satsuma Pharmaceuticals:

Satsuma Pharmaceuticals, Inc. is a clinical-stage biopharmaceutical company focused on developing STS101 (dihydroergotamine mesylate (DHE) nasal powder) as an important and differentiated therapeutic option for the acute treatment of migraine.

Satsuma’s lead product, STS101, is a novel and proprietary investigational drug-device combination product specifically designed to enable intranasal administration of the anti-migraine drug DHE, with a pharmacokinetic profile designed to provide reliable, robust, and consistent clinical performance in the acute treatment of migraine. In developing STS101, Satsuma has applied proprietary nasal drug delivery device, dry-powder formulation, and engineered drug particle technologies to create a compact, simple-to-use, non-injectable DHE product that can be quickly and easily self-administered in matter of seconds.

Purpose:

The Director of Analytical will report to the Head of CMC and will be a key leader in the CMC team.  The role will work with external contract research organizations analytical testing labs (including contract manufacturing organizations) to lead the development, transfer (as needed), and qualification of the analytical testing methods associated with the drug-device combination product(s) being developed by Satsuma.  In addition, the role will include the ability to analyze data and make conclusions and recommendations based on those analyses.  An important part of the role is to ensure the CMC approaches to the NDA (as well as other regulatory submissions) are sound and high quality work is performed.

Duties and Responsibilities:

  • Develop robust analytical test methods that meet quality and regulatory requirements.
  • Manage the transfer of analytical methods between sites, as well as ensure successful qualification, validation, and maintenance of them.
  • Analyze data to determine trends, reach conclusions, and propose actions for the product and/or the methods themselves.
  • Report writing and oversight of internal and external reports.
  • Devise approaches to and contents of the analytical aspects of Satsuma’s regulatory submissions (IND, NDA, MAA).
  • Manage data for reporting in regulatory submissions, including drafting analytical sections of the submissions.
  • Manage all logistics related to analytical testing of R&D, non-clinical and clinical supplies.
  • Supervise junior staff.
  • Collaborate with all functions of the business to ensure consistent delivery of the programs.

Minimum Requirements Education/Experience:

  • Bachelor’s degree in analytical chemistry or similar.
  • Minimum of 10 years’ experience in pharmaceutical industry in an analytical method development and/or analytical testing role.
  • Minimum of 3-5 years’ experience working with across different cultures and disciplines.
  • Experience in drug-device combination products preferred.

Behaviors/Skills: 

  • 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 careers@satsumarx.com

Thomas M. Soloway

Mr. Soloway has been a member of our board of directors since July 2020. He currently serves as Chief Executive Officer of T-knife GmbH, a next-generation adoptive T-cell therapy company leveraging its proprietary humanized T-cell receptor (HuTCR) mouse platform to treat solid tumors, a position he has held since December 2020. From October 2015 to September 2020, Mr. Soloway served as a senior member of the executive team of Audentes Therapeutics, Inc., a gene therapy company focused on developing innovative therapeutics for patients living with serious rare neuromuscular diseases, where he most recently served as Executive Vice President and Chief Operating Officer. Prior to joining Audentes, from January 2014 to September 2015, Mr. Soloway was Senior Vice President and Chief Financial Officer of Ascendis Pharma A/S, a Danish biotechnology company developing long-acting prodrugs in the field of endocrinology, and prior to Ascendis, from September 2002 to December 2013, served as Executive Vice President and Chief Operating Officer of Transcept Pharmaceuticals, Inc. Prior to Transcept, Mr. Soloway was a Principal with Montreux Equity Partners, where he was responsible for sourcing, structuring and leading life-sciences focused venture capital investments. Mr. Soloway earned a B.S. in Entrepreneurial Studies from the University of Southern California and an M.B.A. from the Georgetown University McDonough School of Business.

Thomas B. King

Mr. King has served as a member of our board of directors since September 2017. He has served as an independent biotechnology consultant and advisor since August 2016. Mr. King served as a member of the board of directors of VIVUS, Inc. a publicly traded pharmaceutical company, from May 2017 to December 2020, serving as interim Chief Executive Officer from December 2017 to April 2018 and interim President from April 2018 to May 2018. Mr. King previously served as President, Chief Executive Officer and a member of the board of directors of Alexza Pharmaceuticals, Inc., a publicly traded pharmaceutical company, from June 2003 until it was acquired by Grupo Ferrer in June 2016. From October 2015 to August 2016, Mr. King also served as Chief Financial Officer and Chief Accounting Officer of Alexza Pharmaceuticals, Inc. From September 2002 to April 2003, Mr. King served as President, Chief Executive Officer and a member of the board of directors of Cognetix, Inc., a privately held biopharmaceutical development-stage company. From January 1994 to February 2001, Mr. King held various senior executive positions at Anesta Corporation, a publicly traded pharmaceutical company, including President and Chief Operating Officer from January 1995 to January 1997 and President and Chief Executive Officer from January 1997 to October 2000, and was a member of the board of directors from January 1995 until it was acquired in October 2000 by Cephalon, Inc., a publicly traded biopharmaceutical company. Mr. King currently serves on the board of directors of Concentric Analgesics, Inc. and Kinaset Therapeutics, Inc., both privately held biotechnology companies. Mr. King received a B.A. in chemistry from McPherson College and an M.B.A. from the University of Kansas Graduate School of Business.

Ken Takanashi, MBA, CPA

Mr. Takanashi has served as a member of our board of directors since June 2016. Mr. Takanashi currently serves as Executive Vice President and Chief Operating Officer at Shin Nippon Biomedical Laboratories Ltd., where he has been employed since 2004. Prior to joining Shin Nippon Biomedical Laboratories Ltd., Mr. Takanashi was employed by Suasa Kristal (M) Bhd. from December 1996 to December 2002, most recently as Executive Director and General Manager. He also served as Business Development Manager for Mitsubishi Corporation from April 1987 to November 1996. Mr. Takanashi also currently serves on the board of directors of Wave Life Sciences, Ltd., a public biopharmaceutical company, as well as on the board of directors of several private companies. Mr. Takanashi is a Chartered Public Accountant in Delaware. Mr. Takanashi received a B.A. from The University of Tokyo, and an M.B.A. from The University of Warwick, Coventry U.K..

Rajeev Shah

Rajeev Shah has served as a member of our board of directors since December 2016. Mr. Shah has been a managing partner at RA Capital Management, L.P., a multi-stage investment manager dedicated to evidence-based investing in public and private healthcare and life science companies that are developing drugs, medical devices, and diagnostics, since 2004. Mr. Shah is currently a member of the board of directors of the public companies Kala Pharmaceuticals, Inc., Solid Biosciences, Inc., Eidos Therapeutics, Inc., and Black Diamond Therapeutics, Inc. Mr. Shah was previously a member of the board of directors of KalVista Pharmaceuticals, Inc. from June 2015 through April 2018 and Ra Pharmaceuticals, Inc. from July 2015 through April 2020. Mr. Shah holds a B.A. in Chemistry from Cornell University.

Elisabeth Sandoval

Ms. Sandoval has served as a member of our board of directors since May 2019. Ms. Sandoval currently serves as a consultant to the pharmaceutical industry. From September 2016 to April 2019, Ms. Sandoval served as the Chief Commercial Officer and Executive Vice President of Corporate Strategy of Alder Biopharmaceuticals, a public biopharmaceutical company. Before joining Alder, Ms. Sandoval was Chief Commercial Officer for Kythera Biopharmaceuticals, a publicly traded biopharmaceutical company, acquired by Allergan in 2015, from March 2012 to October 2015. Before Kythera, Ms. Sandoval was Vice President of Marketing for Bausch and Lomb Surgical from November 2010 to November 2012. From October 1987 to October 2010, Ms. Sandoval held various senior commercial roles at Allergan, a publicly traded company, including Vice President of Global Marketing at Allergan. Ms. Sandoval also currently serves on the board of directors of Menlo Therapeutics, a public pharmaceutical company, as well as on the board of directors of one private company. Ms. Sandoval began her career in research and development at Johnson & Johnson’s Ethicon division. She holds an M.B.A. from Pepperdine University and a B.S. in Biology from the University of California, Irvine.