Senior Director, Drug Substance

3 days ago

Boston, United States PepGen Full time

Position Summary


Reporting to the Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively support the preparation of regulatory filings. Technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations are key success factors, along with expert leadership for the completion of planned activities in accordance with agreed scope, timing, and budget. The ideal candidate will thrive in a fast paced, high growth organization.


Responsibilities

  • Support the development of the Drug Substance strategy and oversee manufacturing of preclinical and clinical material.
  • Build and execute long range DS development plans to advance PepGen’s pipeline toward validation and commercial.
  • Manage scientists and lead the DS team across the pipeline to support preclinical and early clinical programs as well as late-stage drugs.
  • Review and approve drug substance development protocols, MBR's, production records, and testing results.
  • Work with the PepGen CMC team to strategically drive the strategy for peptides and oligos according to project goals and development stage.
  • Contribute to day-to-day activities including timeline, budget management, and objective setting in a thriving and growing drug substance group.
  • Collaborate with CMOs and other external partners and assess opportunities stateside and in Europe + Asia and oversee routine manufacturing as a PepGen representative (Person in Plant).
  • Assist in negotiation of third-party contracts.
  • Demonstrate prototypical leadership skills, planning, and organizational capabilities.
  • Implement work plans cross functionally.
  • Manage all logistical issues including inventory of DS and intermediates.
  • Assist with laboratory investigations and the review of investigation reports.


Requirements

  • Requires an advanced degree in Pharmaceutical Sciences, Chemistry, Materials Science, or related field with 5+ years of experience in process development and manufacturing of peptide and oligonucleotide APIs including PMOs.
  • Experience with solid phase peptide/oligo synthesis preferred.
  • Experience working in a cGMP environment required.
  • Experience with chimeric peptide/oligo APIs a plus.
  • Experience with lyophilized APIs a plus.
  • Available to travel if/when needed.


About PepGen

PepGen Inc. is a clinical-stage biotechnology company advancing the next-generation of oligonucleotide therapies with the goal of transforming the treatment of severe neuromuscular and neurological diseases. PepGen’s Enhanced Delivery Oligonucleotide, or EDO, platform is founded on over a decade of research and development and leverages cell-penetrating peptides to improve the uptake and activity of conjugated oligonucleotide therapeutics. Using these EDO peptides, we are generating a pipeline of oligonucleotide therapeutic candidates that target the root cause of serious diseases. For more information, visit www.pepgen.com or follow PepGen on Twitter and LinkedIn.


EEO Statement

PepGen is an Equal Opportunity Employer committed to a culturally diverse workforce. All qualified applicants will receive consideration for employment without regard to race; color; creed; religion; national origin; age; ancestry; nationality; marital, domestic partnership or civil union status; sex, gender, gender identity or expression; affectional or sexual orientation; disability; veteran or military status or liability for military status.


Note: This is not a remote role. We like to work together and operate in a hybrid model in office Tues, Weds & Thurs each week.


Recruitment & Staffing Agencies

PepGen does not accept unsolicited agency resumes. Currently, we are working exclusively with The Bowdoin Group for all our recruiting needs. Thank you.

  • PepGen | Senior Director, Drug Substance | boston, ma

    16 hours ago

    boston, United States PepGen Full time

    Position Summary Reporting to the Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively support...

  • PepGen | Senior Director, Drug Substance | boston, ma

    3 days ago

    boston, United States PepGen Full time

    Position Summary Reporting to the Head of CMC Development, the Senior Director, Drug Substance will be responsible for leading the drug substance team in development and manufacturing as part of PepGen ́s CMC team. This person will manage the drug substance needs of PepGen’s growing pipeline. In addition, this position will be required to actively support...

  • Director, Drug Product

    1 week ago

    boston, United States PepGen Full time

    The Director will be managing drug product manufacturing for PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. In addition to actively supporting the preparation of regulatory filings, the Director will lead the technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations. The right...

  • Director, Drug Product

    1 week ago

    Boston, United States PepGen Full time

    The Director will be managing drug product manufacturing for PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. In addition to actively supporting the preparation of regulatory filings, the Director will lead the technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations. The right...

  • Director, Drug Product

    1 week ago

    Boston, United States PepGen Full time

    The Director will be managing drug product manufacturing for PepGen’s Enhanced Delivery Oligonucleotides (EDOs) pipeline. In addition to actively supporting the preparation of regulatory filings, the Director will lead the technical collaboration and integrated planning with PepGen’s internal CMC team and associated CMO/CRO organizations. The right...

  • Senior Medical Director, Global Drug Safety

    5 months ago

    Boston, United States Alexion 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...

  • Senior Director, Drug Metabolism and Pharmacokinetics

    1 month ago

    Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    Job DescriptionAt Takeda Pharmaceutical, we are a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. Our team is dedicated to pushing the boundaries of what is possible in order to bring life-changing treatments to patients worldwide.Key ResponsibilitiesRepresent the GI2 (Inflammation &...

  • Regional Sales Director

    4 days ago

    Boston, United States Kindeva Drug Delivery Full time

    Kindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business. This position is for the Regional Sales Director for the East Coast.Summary of PositionThe Regional Director of Sales for Kindeva Drug Delivery (KDD) will be based in a US region to lead the development of Kindeva's new business opportunities and growth in...

  • Regional Sales Director

    2 weeks ago

    Boston, United States Kindeva Drug Delivery Company Full time

    Posted Tuesday, October 1, 2024 at 4:00 AMKindeva Drug Delivery is a global pharmaceutical contract developer and manufacturer (CDMO) business. This position is for the Regional Sales Director for the East Coast.Summary of PositionThe Regional Director of Sales for Kindeva Drug Delivery (KDD) will be based in a US region and will lead the development of new...

  • Senior Director Regulatory Affairs

    2 weeks ago

    boston, United States Morgan Prestwich - Life Science & Healthcare Executive Search Full time

    The Senior Director/Executive Director of Regulatory Affairs will be responsible for developing and executing regulatory strategies for all assets at various stages, including IND, NDA, and life cycle management activities across our client’s portfolio. This role requires a highly self-motivated individual who can thrive both independently and as part of a...

  • Senior Director Regulatory Affairs

    1 month ago

    Boston, United States Morgan Prestwich - Life Science & Healthcare Executive Search Full time

    The Senior Director/Executive Director of Regulatory Affairs will be responsible for developing and executing regulatory strategies for all assets at various stages, including IND, NDA, and life cycle management activities across our client’s portfolio. This role requires a highly self-motivated individual who can thrive both independently and as part of a...

  • Senior Director Regulatory Affairs

    1 month ago

    boston, United States Morgan Prestwich - Life Science & Healthcare Executive Search Full time

    The Senior Director/Executive Director of Regulatory Affairs will be responsible for developing and executing regulatory strategies for all assets at various stages, including IND, NDA, and life cycle management activities across our client’s portfolio. This role requires a highly self-motivated individual who can thrive both independently and as part of a...

  • Senior Director Regulatory Affairs

    2 weeks ago

    Boston, United States Morgan Prestwich - Life Science & Healthcare Executive Search Full time

    The Senior Director/Executive Director of Regulatory Affairs will be responsible for developing and executing regulatory strategies for all assets at various stages, including IND, NDA, and life cycle management activities across our client’s portfolio. This role requires a highly self-motivated individual who can thrive both independently and as part of a...

  • Senior Manager/Associate Director, Quality Operations

    4 weeks ago

    Boston, Massachusetts, United States Jobot Full time

    Job DescriptionWe are seeking a highly experienced Senior Manager/Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs.The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.Ensure CMO compliance with...

  • Associate Director, Sterile Drug Products

    3 months ago

    Boston, United States Inozyme Pharma Full time

    Position Overview: We are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. You will play a key role in vendor management and...

  • Senior Medical Director, Oncology

    2 weeks ago

    Boston, United States Mason Harding Full time

    Senior Medical Director, Oncology - AI Drug Discovery & Development On-site – Boston, MassachusettsReady to join the AI drug discovery field, expected to reach $10B+ by 2033?!Mason Harding are proudly supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) to transform drug discovery and development as we know it;...

  • Senior Medical Director, Oncology

    2 weeks ago

    boston, United States Mason Harding Full time

    Senior Medical Director, Oncology - AI Drug Discovery & Development On-site – Boston, MassachusettsReady to join the AI drug discovery field, expected to reach $10B+ by 2033?!Mason Harding are proudly supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) to transform drug discovery and development as we know it;...

  • Senior Medical Director, Oncology

    3 weeks ago

    Boston, United States Mason Harding Full time

    Senior Medical Director, Oncology - AI Drug Discovery & Development On-site – Boston, MassachusettsReady to join the AI drug discovery field, expected to reach $10B+ by 2033?!Mason Harding are proudly supporting a biotech trailblazer within the field of next-gen artificial intelligence (AI) to transform drug discovery and development as we know it;...

  • Senior Director of Sterile Drug Products

    4 weeks ago

    Boston, Massachusetts, United States BioSpace, Inc. Full time

    Job Summary:This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. As a key member of the BioSpace, Inc. team, you will play a crucial role in vendor management and act as the subject matter expert for sterile drug products.Key Responsibilities:Oversee the production...

  • Associate Director, Sterile Drug Products

    4 weeks ago

    Boston, Massachusetts, United States BioSpace, Inc. Full time

    Job OverviewWe are seeking a highly experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. The successful candidate will play a key role in vendor management and act...