Scientist, Analytical Development

Allena Pharmaceuticals, Inc. is a late-stage clinical biopharmaceutical company dedicated to developing and commercializing first-in-class, oral enzyme therapeutics to treat patients with rare and severe metabolic and kidney disorders. Allena’s lead product candidate, reloxaliase, is a first-in-class, oral enzyme therapeutic for the treatment of hyperoxaluria, a metabolic disorder characterized by markedly elevated urinary oxalate levels and commonly associated with kidney stones, chronic kidney disease and other serious kidney disorders. Its second product candidate, ALLN-346, is also a first-in-class, oral enzyme for the treatment of hyperuricemia and gout in the setting of advanced chronic kidney disease.

The company’s proprietary technological approach enables the design, formulation and delivery of non-absorbed and stable enzymes orally and in sufficient doses for activity in the GI tract. This approach results in enzyme therapies that utilize the GI tract to degrade metabolites, such as oxalate and urate, reducing plasma and urine levels, and in turn reducing their disease burden on the kidney over time. Led by a proven management team with deep expertise in protein therapeutic design and development, Allena is committed to bringing breakthrough new treatments to patients with unmet medical needs. Allena is based in Newton, MA, with an office and laboratory in Sudbury, MA.

Scientist, Analytical Development

 

The Analytical Development QC Scientist will be responsible for directing and performing bioanalytical assays to support method qualification and pre-validation related workflows. Successful candidates should have strong laboratory experience in a regulated environment, experience working with proteins and large molecules, and well-developed report writing skills.

Who are we looking for?

  • Energetic individual who will work with the Analytical Development and Quality Control teams to lead method qualification activities
  • A proven performer who can inject creative problem solving and direct method simplification
  • Experience working in or with a regulated laboratory is required

What are we looking for?

  • A creative and focused analytical scientist, able to creatively address novel problems
  • An accomplished individual with a track record of successful method qualification and requisite documentation
  • One who is comfortable in a fast-paced environment where priorities can change quickly
  • A colleague to join our lab as both an individual and team contributor
  • A team member with positive energy who is passionate about asking questions and finding answers.

What are we offering?

  • An opportunity to grow with the Analytical Development department and within CMC
  • An opportunity to interface with QC and across external GMP laboratories within Allena CMO/CTL network
  • Exposure to pioneering science of therapies that utilize the GI tract to degrade metabolites

Responsibilities:

  • Design, perform and record analyses for method qualification and supporting qualified and validated methods.
  • Review data and reports as
  • Develop and review laboratory procedures in collaboration with QC personnel.
  • Provide training and participate in method troubleshooting efforts for validated methods at external labs
  • Provide data summaries, presentations, and detailed
  • Lead method qualification
  • Coordinate research stability studies in conjunction with stability management program
  • Participate in cross-functional meetings to support internal and external partners
  • Be accountable for ensuring proactive execution of work
  • Assist in maintaining a clean, safe
  • Maintenance of laboratory notebook and records in accordance with laboratory requirements, including timely recording and

Education and Experience:

  • Education in Analytical Chemistry, Biochemistry, Molecular Biology or related field and industry experience
  • PhD (1-3 years).
  • Intellectual curiosity and creativity.
  • Ability to function in a small company, collaborative atmosphere and dynamic work environment.
  • Knowledge of basic statistics (SD, RSD, etc.).
  • Hands on experience performing several of the following techniques: Bioassays, ELISA, HPLC, SDS-PAGE, capillary electrophoresis, immunoblots, dynamic light scattering, powder flow evaluation and spray drying.
  • Demonstrated oral and written communication
  • Willingness to collaborate with QC department to develop protocols and procedures
  • Willingness to travel to external labs for analytical support as required
  • Commitment to teamwork and continuous improvement.
  • Ability to focus attention to details and ensure high quality
  • Competence to work safely and encourage safe Can function in a chemical laboratory environment; should have no known sensitivities to chemicals present in the laboratory and no health conditions that preclude working in a chemical laboratory environment.

Competencies:

Adaptability: Responds resourcefully, flexibly, and positively when faced with new challenges, transitions, and demands. Willingly and effectively deals with the stress and complexities of various situations. Moves forward productively and optimistically under conditions of change and uncertainty.

Collaboration: Embodies and promotes collaboration and works effectively with others across the organization to achieve goals. Demonstrates proficient cross-company communication, cultural sensitivity, and partnership in interactions with others. Involves others in decisions and plans and credits them for their contributions and accomplishments.

Communication: Creates an environment which promotes the free flow of communication and information throughout the organization. Communicates effectively in large and small groups. Openly shares knowledge and expertise. Listens actively and encourages the open expression of ideas and opinions.

Execution: Drives execution of strategic and operating plans while maintaining operational effectiveness. Conveys a strong sense of urgency around continuous improvement, achieving high quality results, and accelerating business performance. Addresses problems directly and drives changes necessary to achieve business objectives.

Relationship Building: Establishes and maintains strong relationships internally and externally. Respects and relates well to management, colleagues, peers, and direct reports. Champions a culture of respect, diversity and inclusion that values and respects individuals. Earns the respect of others through principled leadership, sound business ethics, and authenticity.

When You Join Allena You Will Have:

  • Free parking, Newton location reachable by public transportation (Green Line)
  • Customized and competitive health coverage including medical offered through BCBS (HMO/PPO), dental, and vision
  • Flexible Spending Accounts for medical and dependent care expenses
  • Eligible from the first day for 401K with 100% match of the first 4%
  • Robust package of Allena paid insurance coverage, including life insurance, short-term and long-term disability
  • 15 days of vacation and 5 personal days per year, in addition to 14 company holidays and 2 floating holidays
  • Winter Break: Allena is closed for a Winter Break between Christmas and New Year

*Required field.

TO ALL AGENCIES: Please, no phone calls or emails to any employee of Allena about our openings. All résumés submitted by search firms/employment agencies to any employee at Allena via email, the internet, or in any other form and/or method will be deemed the sole property of Allena, unless such search firms/employment agencies were engaged by Allena for this position and a valid agreement with Allena is in place. In the event a candidate who was submitted outside of the Allena agency engagement process is hired, no fee or payment of any kind will be paid.

Allena Pharmaceuticals, Inc. is an equal employment opportunity employer and does not discriminate against any applicant because of race, creed, color, age, national origin, ancestry, religion, gender, sexual orientation, disability, genetic information, veteran status, military status, application for military service, or any other class protected by state or federal law.

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Jerome Gangitano

Vice President of Manufacturing and Process Development

Jerome Gangitano is the Vice President of Manufacturing and Process Development at Allena Pharmaceuticals. He is an experienced operations executive with more than 30 years of experience in the pharmaceutical and device industries. He has developed, commercialized, and supplied numerous products.

Prior to joining Allena, Jerome was a Site Head at Sanofi where he led a site including Safety and Environmental, Quality, Manufacturing, Process Development – MSAT; Facilities-Engineering, Supply Chain, Materials Purchasing, and Operational Excellence. Prior to his time at Sanofi, Jerome held various leadership positions in Operations, Manufacturing, and Quality at Genzyme, Focal, Johnson & Johnson, and Multiple Peptide Systems. Jerome received his BS in Chemistry from San Diego State University.

Kevin Brennan

Vice President, Finance

Kevin Brennan is the Vice President Finance at Allena Pharmaceuticals. Kevin joined the Allena team in 2011 as the Associate Director, Finance and has played an integral role in financial strategy, planning and operations, and the development and monitoring of systems designed to manage the organization’s finance and reporting. Kevin brings over twenty years of experience in the life science industry. Prior to joining Allena, Kevin held various positions at Alnara Pharmaceuticals, Altus Pharmaceuticals, and Genzyme, where he worked cross-functionally to drive strategic initiatives and optimize planning and reporting processes.

Kevin holds a B.S. in Accounting from Boston College.

Stephen Yu

Senior Vice President, Corporate Quality

Stephen Yu is Senior Vice President of Corporate Quality at Allena Pharmaceuticals. Stephen provides leadership for the internal Quality Assurance and Quality Control functions and oversight across internal and external GxP activities for Allena’s programs and facilities.

Stephen brings over 40 years of drug development and commercialization experience in technical and quality compliance roles. Over the past year, he has worked as Senior Vice President of Quality at Lyndra Therapeutics, a private company based in Watertown. In addition to serving previously as Vice President of Quality Assurance at Allena, Stephen has led his self-directed consultancy, Sky Pharma Consulting, and held prior roles as Vice President of Corporate Quality at Immunogen, as well as roles in Quality and Manufacturing at Genzyme, Merck & Co and Schering-Plough Research Institute.

Stephen earned a B.S. in Chemical Engineering from M.I.T. and an M.B.A. from Rutgers University.

Richard Katz, M.D.

Chief Financial Officer

Richard Katz, M.D. has served as chief financial officer since January 2021. Richard brings to Allena more than 20 years of experience in healthcare finance and corporate development.

Prior to joining Allena, Richard served as the chief financial officer of several biopharmaceutical companies, including Liquidia Technologies, Argos Therapeutics, Viamet Pharmaceuticals and Icagen, Inc. At Icagen, he played an instrumental role in the company’s initial public offering and subsequent financings, the formation of several strategic collaborations and the company’s sale to Pfizer. Richard began his career as a vice president in the healthcare investment banking group at Goldman, Sachs & Company, where he executed a broad range of transactions, including equity and debt financings, mergers and acquisitions, and corporate restructurings.

He holds a B.A. in applied mathematics from Harvard University, an M.D. from the Stanford University School of Medicine and an M.B.A. from Harvard Business School.

Alicja Januszewicz, PhD.

Vice President, People & Culture

Alicja Januszewicz, Ph.D., has served as the Head of People & Culture since 2019. Before joining Allena, she consulted with small organizations in Cambridge within talent management: employee development, organizational development, succession management, high potentials, and workforce planning. Previously, she had served as the Head of Talent Management at Baxalta Innovation Center, where she supported global R&D teams until the Shire acquisition.

Prior to joining Baxalta, Alicja served as Head of Talent Management at Epizyme and Boston Scientific HQ. She also supported the organizational development of Genzyme’s global HR manufacturing group.

Alicja holds a Ph.D. in Sociology from the Polish Academy of Science. She is a graduate of the Talent Management Institute, University of North Carolina, Kenan-Flagler Business School.

David J. Clark, M.D.

Chief Medical Officer

David J. Clark, M.D. has served as Chief Medical Officer since November 2020. He has over 20 years of global industry experience in biopharmaceutical companies based in the United States and Europe.

Before joining Allena, David served as the Chief Medical Officer of Aldeyra Therapeutics, a publicly-traded biotechnology company developing medicines for immune-mediated ocular and systemic diseases. He also served as Chief Medical Officer of Wilson Therapeutics, a privately-held biotechnology company developing novel pharmaceuticals to treat Wilson Disease, a rare autosomal recessive disorder of copper metabolism. David further served as Chief Medical Officer at NormOxys Inc. and TransTech Pharma, LLC. He has held leadership positions at a range of pharmaceutical companies including Pfizer, GlaxoSmithKline, and SmithKline Beecham.

David received his medical degree from the University of Edinburgh, trained in internal medicine, and conducted respiratory medicine academic research.

Geoffrey Swire

Acting Chief Operating Officer and Senior Vice President, Corporate Development

Geoffrey Swire joined Allena in 2018 and currently serves as Acting Chief Operating Officer and Senior Vice President, Corporate Development. Geoffrey has 20 years of leadership experience in business, product, and commercial development for life sciences companies.
 
Geoff previously worked at Radius Health, where he served as head of business development and alliance management, and earlier as program leader for the global Phase 3 osteoporosis development program. Prior to that, Geoff spent seven years at Genzyme, where he held various leadership positions in the Transplant and  Oncology business units, including as head of program and portfolio management, as well as vice president of global commercial operations. Geoff played a central role in the acquisition, development, regulatory approvals, and global commercial launch of Mozobil for patients undergoing stem cell transplants. He started his career in strategy and product development consulting at Integral, Inc., and Accenture’s Health & Life Sciences practice.

Geoff holds a B.A. in French and History from Dartmouth College and a Master’s in Public Policy from Harvard University

Hugh Wight

Senior Vice President, Technical Operations

Hugh Wight is senior vice president of technical operations at Allena Pharmaceuticals. He is an experienced manufacturing executive with more than 20 years in pharmaceutical and biopharmaceutical development, manufacturing, validation and quality assurance.

Prior to joining Allena, Hugh was vice president, technical operations for Alnara Pharmaceuticals, where he led manufacturing, project management, quality assurance and control, and fostered strategic partnerships with manufacturing organizations. Prior to his time at Alnara, Hugh held various quality assurance and validation leadership positions at Altus Pharmaceuticals, Alkermes, Aquila Biopharmaceuticals, AutoImmune and InSite Vision.

Hugh holds a B.S. in microbiology from the University of Maine-Orono.

Louis Brenner, MD

President and Chief Executive Officer

Lou Brenner, MD, has served as chief executive officer of Allena since February 2019 and as president since February 2017. He previously served as chief operating officer from April 2015 to January 2019.

Lou has more than a decade of industry leadership experience, including pharmaceutical development strategy, regulatory affairs, business development, and commercialization. Prior to joining Allena, Lou served as chief medical officer at Idera Pharmaceuticals, chief medical officer at Radius Health, and senior vice president at AMAG Pharmaceuticals. He began his industry career at Genzyme Corporation, where he led successful product development programs for medicines that are currently marketed in the renal and metabolic areas.

He holds an MD from Duke University, an MBA from Harvard Business School, and a BS from Yale University, He completed his residency in internal medicine at Brigham and Women’s Hospital and his fellowship in nephrology at Brigham and Women’s Hospital and Massachusetts General Hospital. Lou holds a clinical appointment at Brigham and Women’s Hospital.