Senior Director, Drug Substance Development

3 days ago

Cambridge, Massachusetts, United States Akebia Therapeutics Full time
Job Summary

Akebia Therapeutics is seeking a Senior Director, Drug Substance to provide operational and strategic leadership to the Drug Substance organization within Technical Operations. The successful candidate will be responsible for developing and optimizing Akebia's clinical and commercial programs, ensuring timely delivery of clinical and commercial drug substance inventory.

Key Responsibilities
  • Provide strategic, technical, and managerial leadership related to drug substance strategies for the development, optimization, scale-up, and manufacturing for Akebia's clinical and commercial programs.
  • Lead project teams by providing oversight of project milestones, drive activities with additional project team members, manage timelines, contracts and invoices, and accountability for entire project.
  • Collaborate with Akebia's Medicinal Chemistry group to support route scouting of research compounds, identify pre-Phase 1 process development/optimization opportunities, identification and determination of known and potential process impurities, and support the manufacturing of material to be utilized in GLP toxicology studies.
  • Collaborate with Akebia cross-functional teams to support overall program strategies, goals and objectives.
  • Manage and oversee activities at contract organizations worldwide to assure compliant and robust manufacturing processes are both developed and/or maintained.
  • Responsible and accountable for the timely production of clinical and commercial drug inventory to support Akebia clinical programs and supply for established commercial programs.
  • Author, review and approve technical protocols and reports.
  • Review and approval of commercial process validation related documentation including validation plans, manufacturing stage specific protocols, and validation reports.
  • Employing the principles of Continuous Process Verification (CPV), evaluate and analyze manufacturing data through the use of statistical tools to develop process understanding, establishment of critical process parameters and in-process controls, and the identification of process improvements.
  • Hire, mentor and develop a world class drug substance organization by identifying experienced candidates and by providing coaching and feedback to all Drug substance personnel.
  • Support regulatory submissions by writing/reviewing/approving drug substance related sections.
  • Represent the Drug Substance organization on program teams.
Requirements
  • Bachelor's, Master's, or Ph.D. Degree in Pharmaceutical Sciences, Organic Chemistry, Biochemistry, Chemical Engineering or a related scientific discipline.
  • 15+ years of relevant industry experience with at least 5 years in a leadership position.
  • Extensive knowledge and experience in the development and manufacture of small molecules.
  • Strong problem-solving ability utilizing experience and data analysis to quickly drive scientifically sound decisions and solve development and manufacturing issues quickly.
  • Well-developed knowledge of relevant ICH guidelines, GMPs and global regulatory requirements.
  • Experience through all stages of the development lifecycle (Phase 1 through Validation), including leading commercial manufacturing oversight at contract manufacturing organizations.
  • Demonstrated acumen and program success with respect to phase appropriate chemical synthetic manufacturing processes supporting clinical and commercial programs.
  • Experience in managing activities at contract development and manufacturing organizations.
  • Ability to critically review and approve development and commercial documents (protocols, reports, batch records, regulatory filings) and extract relevant data for analysis and trending.
  • Experience in supporting global regulatory filings (IND, NDA, CTA, IMPD, MAA, etc.).
  • Up to 25% of time for international and domestic travel may be required.
  • Ability and desire to work in a fast-paced and dynamic environment.
  • Knowledgeable in GMPs and relevant regulatory requirements.
  • Demonstrated effective time management skills.
  • Sound judgment and commitment to ethical conduct.
  • Strong collaboration, team building and communication skills.

  • Director of Drug Substance Development

    4 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Title: Director of Drug Substance DevelopmentLocation: Cambridge, MA (Onsite)Job Overview: We are seeking a highly experienced Director of Drug Substance Development to lead our CMC Drug Substance efforts. As the process chemistry SME, you will oversee the strategy and operations of our drug substance development programs in clinical development leading...

  • Senior Director, Drug Substance Development

    4 days ago

    Cambridge, Massachusetts, United States Akebia Therapeutics Full time

    Job SummaryAkebia Therapeutics is seeking a highly experienced Senior Director, Drug Substance to provide operational and strategic leadership to the Drug Substance organization within Technical Operations. The successful candidate will be responsible for developing and optimizing Akebia's clinical and commercial programs, leading project teams, and...

  • Senior Director of Formulation Development

    4 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Title: Senior Director, Formulation 2040406Location: Remote OpportunityJob Overview: Stratacuity is seeking a seasoned Senior Director to lead the formulation development for oral dosage forms. As a primary technical expert, you will spearhead scientific strategy, manage project assignments, and partner with cross-functional teams to expedite development...

  • Senior Director, Formulation Development

    3 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job Title: Senior Director, Formulation DevelopmentLocation: Cambridge, MA (Onsite)Job Overview: Stratacuity is seeking a Senior Director, Formulation Development to lead the formulation development for oral dosage forms for clinical trials and potential market release. As a primary technical expert, you will manage external partnerships for drug product...

  • Senior Director of Formulation Development

    3 weeks ago

    Cambridge, Massachusetts, United States Apex Systems Full time

    Job Title: Senior Director, FormulationJob Description:Apex Systems is seeking a highly experienced Senior Director to lead our formulation development team. As a key member of our team, you will be responsible for spearheading scientific strategy in formulation aligned with clinical and company goals.Key Responsibilities:Manage formulation team project...

  • Senior Director of Quality Control

    5 days ago

    Cambridge, Massachusetts, United States Beam Therapeutics Inc. Full time

    Job Title: Senior Director, Quality ControlBeam Therapeutics Inc. is seeking a highly experienced Senior Director of Quality Control to join our team in Cambridge, Massachusetts.Job Summary:The Senior Director of Quality Control will be responsible for leading the quality control organization at Beam's Massachusetts facility. This role will oversee the QC...

  • Senior Director of CMC Technical Innovation

    3 weeks ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Senior Director CMC Technical InnovationProclinical Staffing is seeking a seasoned professional to lead our Technical Operations team in Gene Therapy development. As a Senior Director of CMC Technical Innovation, you will drive technical innovation, enhance our capabilities, and maintain our position as a world leader in the industry.Key...

  • Senior Director, Drug Safety and Pharmacovigilance Operations Lead

    3 days ago

    Cambridge, Massachusetts, United States Leap Therapeutics Full time

    Job Title: Senior Director, Drug Safety and Pharmacovigilance OperationsLeap Therapeutics is seeking a highly experienced Senior Director to lead our Pharmacovigilance Operations team. As a key member of our organization, you will be responsible for overseeing the safe and effective management of our clinical trials, ensuring compliance with regulatory...

  • Senior Director of Formulation Development

    4 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewStratacuity is seeking a highly experienced Senior Director, Formulation to lead the formulation development for oral dosage forms for clinical trials and potential market release. As a primary technical expert, you will manage external partnerships for drug product development and spearhead scientific strategy in formulation aligned with...

  • Senior Director of Formulation Development

    3 weeks ago

    Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full time

    Job OverviewStratacuity is seeking a highly experienced Senior Director, Formulation to lead the formulation development for oral dosage forms for clinical trials and potential market release. As a primary technical expert, you will manage external partnerships for drug product development and spearhead scientific strategy in formulation aligned with...

  • Senior Director of Technical Innovation

    1 month ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Technical Innovation to lead our Gene Therapy team at Proclinical Staffing. This is a permanent position based in Massachusetts.Key ResponsibilitiesDevelop and implement a centralized innovation framework to drive the implementation of new technology and streamline IP engagement.Expand our...

  • Associate Director, Drug Development Project Management

    3 days ago

    Cambridge, Massachusetts, United States Bristol-Myers Squibb Full time

    Job SummaryWe are seeking an experienced Associate Director, Project Management to join our team in Cambridge Crossing, MA. As a key member of our Global Program Team, you will be responsible for leading the strategic and operational planning and decision-making process for early and late development programs.Key ResponsibilitiesPartner with the Global...

  • Senior Director of Technical Innovation

    1 month ago

    Cambridge, Massachusetts, United States Proclinical Staffing Full time

    Job SummaryWe are seeking a highly experienced Senior Director of Technical Innovation to lead our Gene Therapy team at Proclinical Staffing. As a key member of our organization, you will be responsible for driving technical innovation and advancing our Technical Operations platform.Key ResponsibilitiesEstablish a Centralized Innovation Framework: Develop...

  • Senior Director of Analytical Development and Quality Control

    5 days ago

    Cambridge, Massachusetts, United States Foghorn Therapeutics Full time

    Position OverviewCompany Culture: Why Choose Us?At Foghorn Therapeutics, we prioritize a "People First, Mission Always" ethos. Our team is our greatest asset, and we embrace the rich diversity of backgrounds, ideas, and experiences that our members contribute. With over 22 languages spoken and representation from more than 24 nationalities, we recognize our...

  • Associate Director, Analytical Development, CMC

    3 weeks ago

    Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    Job Title: Associate Director, Analytical Development, CMCAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and...

  • Associate Director, Analytical Development, CMC

    4 days ago

    Cambridge, Massachusetts, United States Agios Pharmaceuticals Full time

    About the RoleAgios Pharmaceuticals is seeking a highly motivated and experienced Associate Director, Analytical Development, CMC to join our growing CMC team. As a key stakeholder within analytical development, you will be responsible for building and leading the analytical development function within CMC and contributing to the overall CMC strategy of drug...

  • Associate Director, Drug Development Project Management Lead

    2 weeks ago

    Cambridge, Massachusetts, United States Bristol-Myers Squibb Full time

    Job SummaryWe are seeking an experienced Associate Director, Drug Development Project Management to join our team at Bristol-Myers Squibb. As a key member of our Global Program Team, you will be responsible for leading the strategic and operational planning and decision-making process for early and late development programs.Key ResponsibilitiesPartner with...

  • Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations

    3 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryTakeda is seeking a highly skilled and experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and drug-device...

  • Senior Director of Development

    4 days ago

    Cambridge, Massachusetts, United States Harvard University Full time

    Job Title: Senior Director of DevelopmentHarvard University is seeking a seasoned fundraising leader to serve as the lead strategist in formulating and executing plans to advance fundraising priorities for the Harvard John A. Paulson School of Engineering and Applied Sciences (SEAS).About the RoleThis senior fundraising leader will partner with major and...

  • Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations

    3 weeks ago

    Cambridge, Massachusetts, United States Takeda Full time

    Job SummaryTakeda is seeking a highly experienced Senior Director and Regulatory Platform Lead for Device and Drug-Device Combinations to join our team. As a key member of our regulatory affairs department, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and drug-device combinations.Key...