Senior Director, Drug Substance

4 weeks ago


Boston MA, United States Spyre Therapeutics Full time

Summary:
The Senior Director, Drug Substance, Technical Operations, plays a key leadership role responsible for antibody drug substance development and manufacturing throughout product lifecycle. This strategic position is responsible for leading technical operations for drug substance development and manufacturing. The Senior Director, Drug Substance is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to build the drug substance organization and involves close coordination with various teams including drug product, analytical sciences, supply chain, clinical operations, regulatory, quality, and management.

Key Responsibilities:
• Provide strategic and technical leadership for drug substance operations
• Lead all aspects of outsourced drug substance development and manufacturing activities
• Ensure compliance with FDA, cGMPs, ICH guidelines, and QBD principles
• Build, develop and lead internal/external drug substance team, capabilities and network
• Partner with internal and outsourced project teams to achieve business goals
• Author, review and approve technical documents and regulatory filings

Ideal Candidate:
• Bachelor’s degree or advanced degree in relevant scientific or engineering field.
• Minimum 15+ years of relevant experience in biotech/pharma industry, with a focus on drug substance development and manufacturing for antibody products.
• Demonstrated track record of leading outsourced antibody drug substance operations.
• Experienced with CDMO management and outsourcing drug substance operations with demonstrated ability to effectively manage CDMOs globally
• Strong scientific expertise in development and commercialization of antibody co-formulation.
• Proven track record in successful drug submissions (IND, BLA, IMPD, MAA, etc.) and familiarity with phase-appropriate cGMP requirements.
• Exceptional problem-solving and decision-making skills, with the ability to integrate complex scientific information into drug development plans.
• Strong leadership skills with experience in managing and mentoring a high-performing team.
• Highly experienced with cGMPs, FDA, EU, ICH guidelines and CMC regulatory submissions
• Detail-oriented with a talent for anticipating and mitigating risks/issues.
• Excellent communication skills and the ability to work effectively in a fast-paced environment.
• Experience in a small company or start-up environment is preferred.

What We Offer
• Opportunity to work in a fast-paced, dynamic environment where you help shape the culture of our young company, contribute broadly to advance meaningful medicines, and learn quickly.
• Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.
• Flexible PTO
• Two, one-week company-wide shutdowns each year.
• Commitment to provide professional development opportunities.
• Remote working environment with frequent in-person meetings to address complex problems and build relationships.

The expected salary range offer for this role is $255,000 to $270,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.

#J-18808-Ljbffr

  • Boston, United States Astria Therapeutics, Inc. Full time

    Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...


  • Boston, United States Astria Therapeutics, Inc. Full time

    Title: Senior Director, Head of Drug Substance Position Overview:Astria Therapeutics is dedicated to bringing hope with life-changing therapies to patients and families affected by allergic and immunological diseases. Astria’s pipeline includes our lead program, STAR-0215, a monoclonal antibody inhibitor of plasma kallikrein in clinical development for the...


  • Boston, United States Third Rock Ventures Full time

    As a word, Rapport describes relationships characterized by understanding, communication, teamwork, and trust. We reflect those qualities in our daily work, where we operate as one committed team that captures the collective knowledge and experience of all our members to maximally improve patients' lives. And at a higher level we share an ambition and a...


  • Boston, MA, United States Meet Full time

    CompetitiveBoston, United StatesPermanentAn exciting opportunity with a pioneering pharmaceutical company dedicated to advancing healthcare through innovative drug development within Neurology. With a focus on breakthrough therapies, striving to improve the lives of patients worldwide.Position Overview:This innovative organization is looking to bring on a...


  • Boston, United States The Elle Group Full time

    The Senior Director, Drug Safety and Pharmacovigilance is responsible for leading safety surveillance and ensuring compliance with legal and regulatory requirements for pharmacovigilance, signal management, and risk management. - MD degree and board certification preferred - First in Human-Post Marketing experience - 7+ years of experience as a safety...


  • Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...


  • Boston, United States Alexion Pharmaceuticals, Inc. Full time

    This is what you will do: The Senior Medical Director provides global strategic and operational oversight of Alexion's Safety Surveillance and Risk Management activities for assigned therapeutic area in fulfillment of global legislation and regulations. The jobholder defines the Safety Surveillance and Risk Management strategy and ensures its execution...


  • Boston, United States EMO Health Full time

    Job Overview: The Director of Substance Use Disorder (SUD) Services is a key leadership position responsible for overseeing and coordinating the programs and services that EMO Health delivers to substance use disorder providers and patients. This includes assistance with EMO program development, implementation, evaluation, and ensuring compliance with...


  • Boston, United States Third Rock Ventures Full time

    As our clinical development portfolio evolves, Tango has an exciting new opportunity to join our team as a Director/Senior Director, Clinical Pharmacology. Reporting to our SVP, Pharmaceutical Sciences, you will be responsible for the design and implementation of clinical pharmacology aspects of patient trials and NDA-enabling clinical pharmacology studies....


  • Boston, United States Department of Public Health Full time

    As a member of the Office of Statistics and Evaluation (OSE), the Substance Addiction Data Analyst is responsible for assisting the OSE director with the ongoing development and improvement of Bureau of Substance Addiction Services (BSAS) data warehouse and coordination of data quality improvement initiatives. The data maintained in the BSAS data warehouse...


  • Boston, United States Tango Therapeutics Full time

    Company Overview Tango Therapeutics is a biotechnology company dedicated to discovering novel drug targets and delivering the next generation of precision medicine for the treatment of cancer. Using an approach that starts and ends with patients, Tango leverages the genetic principle of synthetic lethality to discover and develop therapies that take aim at...


  • Boston, MA, United States ProClinical Full time

    Senior Director, Oncology Translational Medicine - Permanent - Boston, MAProclinical is seeking a highly skilled Senior Director of Translational Medicine. This is a permanent position located in Boston, MA.Primary Responsibilities:This role is an exciting opportunity to be part of a cutting-edge Clinical Development team, advancing our precision medicine...


  • Boston, United States HireMinds Full time

    Director, Bioprocess Development Boston, MA Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...


  • Boston, MA, United States ProClinical Full time

    Senior Director, Antibody Bioconjugate Discovery - Boston, MA - Permanent Proclinical Staffing is seeking a Senior Director, of Antibody Bioconjugate Discovery to join an innovative biotech developing next generation neurogenetic medicines. This is a permanent role located in Boston, MA.Primary Responsibilities:In this role, you will oversee all aspects of...


  • Boston, United States HireMinds Full time

    Director, Bioprocess DevelopmentBoston, MAOur vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...


  • Boston, United States HireMinds Full time

    Director, Bioprocess DevelopmentBoston, MAOur vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...


  • Boston, Massachusetts, United States Proclinical Full time

    Senior Director, Regulatory Affairs - Permanent - RemoteProclinical Staffing is seeking a Senior Director, Regulatory Affairs to join a leading health information technology and clinical research organization. This is a permanent role with the opportunity to work remotely.Primary ResponsibilitiesIn this role, you will provide leadership and advice on the...


  • Boston, MA, United States Genentech Full time

    The PositionRoche’s Clinical Development organization is structured by therapeutic area and is responsible for developing and executing the late development (Phase II – III) clinical strategies and plans that deliver medically-differentiated therapies that provide meaningful improvement to patients. Due to new projects in the cardiovascular therapeutic...


  • Boston, United States Boston Public Health Commission Full time

    Recovery Services Bureau Recovery Services offers comprehensive programming and resources aimed at preventing substance misuse and supporting the treatment and recovery for those impacted by substance use disorders. Services are provided at two locations in Boston and cover critical gaps in the continuum of care including comprehensive drug user health...


  • South Boston, United States Inozyme Pharma Full time

    Senior Director, Regulatory Strategy Company Overview: Inozyme Pharma, Inc. (Nasdaq: INZY) is a clinical-stage rare disease biopharmaceutical company developing novel therapeutics for the treatment of diseases of abnormal mineralization impacting the vasculature, soft tissue, and skeleton.Position Overview: As the Senior Director of Regulatory Strategy, you...