Current jobs related to Senior Director, Drug Substance - Boston - PepGen

  • Senior Director, Drug Substance

    3 months ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionSenior Director, Drug Substance Position Summary  Reporting to the VP, 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...

  • Senior Director, Head of Drug Substance

    2 months 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

    4 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

    3 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

    2 months 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 Development

    2 weeks ago

    Boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director Drug Substance Development

    2 days ago

    boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director Drug Substance Development

    4 days ago

    boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director Drug Substance Development

    3 weeks ago

    Boston, United States STEMSourcing Full time

    Our valued client is a clinical-stage biotech company in the field of targeted protein degradation (TPD). They are looking for a talented Scientist to join their team as the Director of Drug Substance development. In this role, you will lead the Drug Substance strategic, tactical, and scientific deliverables for one of our key programs and serve as the...

  • Director/Senior Director Drug Substance Antibodies

    4 weeks ago

    Boston, MA, United States AL Solutions Full time

    DescriptionLead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.Work with internal and external stakeholders to achieve on time targets.Regulatory data creation to author documentation supporting filings and responses to health authorities globally.Manage leadership and operational...

  • Scientist, Drug Substance Development

    2 weeks ago

    Boston, United States OSI Full time

    Scientist – Drug Substance Development Responsibilities Contribute to the process development of peptides, oligonucleotides, conjugates, and key raw materials essential for PepGen's platforms.Collaborate with the discovery and analytical development team to develop optimized chromatography processes for purifying target entities.Assist in managing drug...

  • Scientist, Drug Substance Development

    1 week ago

    Boston, United States PepGen Full time

    Job DescriptionJob DescriptionScientist - Drug Substance DevelopmentResponsibilitiesContribute to the process development of peptides, oligonucleotides, conjugates, and key raw materials essential for PepGen’s platforms.Collaborate with the discovery and analytical development team to develop optimized chromatography processes for purifying target...

  • Senior Medical Director, Global Drug Safety

    2 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 Program Manager, Drug Development

    11 hours ago

    Boston, Massachusetts, United States PepGen Full time

    Job OverviewAssociate Director/Director, Program Management, Drug Development Position SummaryWe are seeking a seasoned Program Management Director to support one or more cross-functional early development and clinical stage programs. This individual will report into the Senior Vice President, Program & Portfolio Management and will work closely with Program...

  • Associate Director, Sterile Drug Products

    3 weeks ago

    Boston, Massachusetts, 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 act...

  • Associate Director, Sterile Drug Products

    3 weeks ago

    Boston, United States Inozyme Pharma Full time

    Title: Associate Director, Sterile Drug Products & Vendor ManagementPosition 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...

  • Associate Director, Sterile Drug Products

    3 weeks ago

    Boston, United States Inozyme Pharma Full time

    Title: Associate Director, Sterile Drug Products & Vendor ManagementPosition 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...

  • Associate Director, Sterile Drug Products

    2 weeks 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 Director of Housing Administration

    2 months ago

    Boston, United States Pine Street Inn Full time

    Job DescriptionJob DescriptionDescription:SCHEDULE: Exempt. Generally, Monday – Friday 8:30 a.m. to 5:00 p.m. Additionally, the position requires an appropriate level presence and leadership for 24/7 operations, including weekends.Summary of the Position:Reporting to the Chief of Programs, the Senior Director of Housing Administration provides leadership...

  • Senior Director of Housing Administration

    1 month ago

    Boston, United States Pine Street Inn Full time

    Job DescriptionJob DescriptionDescription:SCHEDULE: Exempt. Generally, Monday – Friday 8:30 a.m. to 5:00 p.m. Additionally, the position requires an appropriate level presence and leadership for 24/7 operations, including weekends.Summary of the Position:Reporting to the Chief of Programs, the Senior Director of Housing Administration provides leadership...

Senior Director, Drug Substance

2 months ago

Boston, United States PepGen Full time
Job DescriptionJob Description

Senior Director, Drug Substance 


Position Summary  

Reporting to the VP, 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. 

Powered by JazzHR

JpmJkhowGX