Director, Drug Substance

3 weeks ago

Boston MA, United States Spyre Therapeutics Full time

Summary:
The Director, Drug Substance, Technical Operations, plays a leadership role responsible for antibody drug substance development and manufacturing throughout product lifecycle. This role provides the opportunity to help 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 10+ 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.
• Unlimited 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 $210,000 to $235,000. Actual pay offered may vary depending on job related knowledge, experience, education, and geographic location.

#J-18808-Ljbffr

  • Senior Director, Drug Substance

    3 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...

  • Senior Director, Head of Drug Substance

    3 weeks ago

    Boston, MA, 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...

  • Senior Director, Head of Drug Substance

    2 weeks ago

    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...

  • Senior Director, Head of Drug Substance

    2 weeks ago

    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...

  • Senior Director, Head of Drug Substance

    3 weeks ago

    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...

  • Senior Director, Head of Drug Substance

    6 days ago

    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...

  • Senior Director, Head of Drug Substance

    6 days ago

    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...

  • Senior Director, Head of Drug Substance

    6 days ago

    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...

  • Director, Drug Substance Manufacturing

    5 days ago

    Boston, United States Rapport Therapeutics 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...

  • Senior Director, Drug Product

    3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, Drug Product (Technical Operations) position is a key leadership role responsible for antibody drug product development and manufacturing. The Senior Director, Drug Product is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer. This role provides the opportunity to...

  • Clinical Director

    3 weeks ago

    Boston, MA, United States Addp Full time

    Schedule: Mon-Fri (With rotating on-call schedule on the weekends) Salary: TBD Responsibilities: Bay Cove Human Services, Inc. a leading Massachusetts human services organization, seeks a Clinical Director to join us in our mission to provide high-quality services to adults who face the life-long challenges of mental illness, aging and drug and alcohol...

  • Senior Director, Drug Safety and Pharmacovigilance

    2 weeks ago

    Boston, MA, 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...

  • Director, Bioprocess

    3 weeks ago

    Boston, MA, United States EPM Scientific - Phaidon International Full time

    Director, Bioprocess Company Summary: A small, clinical-stage biopharmaceutical research company is currently seeking a driven, motivated, and enthusiastic Director, Bioprocess. This position is located the Greater Boston area. You will play a key role in providing technical expertise for leading and developing early-stage clinical programs. The...

  • Clinical Director

    3 weeks ago

    Boston, MA, United States Addp Full time

    Schedule: Mon-Fri (With rotating on-call schedule on the weekends) a leading Massachusetts human services organization, seeks a Clinical Director to join us in our mission to provide high-quality services to adults who face the life-long challenges of mental illness, aging and drug and alcohol dependency. As an integral member of the management staff, the...

  • Executive/Senior Medical Director, Pharmacovigilance

    7 hours ago

    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...

  • VP, Drug Safety

    3 weeks ago

    Boston, MA, United States Meet Full time

    An 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 highly experienced and dynamic VP,...

  • Clinical Director

    1 week ago

    Boston, United States ADDP Full time

    Schedule: Mon-Fri (With rotating on-call schedule on the weekends) Salary: TBD Responsibilities: Bay Cove Human Services, Inc. a leading Massachusetts human services organization, seeks a Clinical Director to join us in our mission to provide high-quality services to adults who face the life-long challenges of mental illness, aging and drug and alcohol...

  • Director/Senior Director, Analytical Development

    3 weeks ago

    Boston, MA, United States Scorpion Therapeutics Full time

    Job Description The position is responsible for technical leadership of analytical development within the CMC function across Scorpion’s portfolio. Analytical Development has responsibility for analytical activities from late-stage Discovery (lead optimization, development candidate nomination) through early-stage clinical development for small molecule...

  • Director, Microbial Process Development

    1 week ago

    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...

  • Senior Director, CMC Operations

    3 weeks ago

    Boston, MA, United States Spyre Therapeutics Full time

    Summary: The Senior Director, CMC Operations (Technical Operations) position is a key leadership role responsible for planning and execution of development, manufacturing, and supply chain activities. The Senior Director, CMC Operations is a high impact role on the Technical Operations Leadership Team, reporting directly to the Chief Technical Officer....