Senior Expert Technical Development Drug Product Project Lead
3 days ago
As a Cell Therapy Process Development Drug Product Project Lead, you will be accountable for Drug Product-related project activities. In this role, you will lead, manage, coach, and support the project sub-team by fostering a culture of innovation, empowerment, trust, learning, diversity, and inclusion.
Key Responsibilities:- Lead the discipline sub-team, act as a project manager, and be accountable for all project activities within Process Development Drug Product line unit.
- Own the discipline project strategy in alignment with the technical development plan (TDP) and represent the project sub-team discipline in the CMC team as a core member.
- Set priorities and objectives within the DP sub-team in alignment with the TDP and the CMC objectives and update CMC team on technical issues, risks, and mitigation strategies.
- Oversee the study design, provide guidance to functional leads (FLs), and ensure adherence to project development strategy.
- Define the DP control strategy and track project progress according to defined timelines.
- Identify roadblocks/risks and issues, develop solutions and mitigation plans/scenarios, and proactively report them to respective stakeholders and governance boards.
- Compile and provide financial forecast for project-specific development activities needed to reach the program milestone.
- Manage project-specific compliance aspects, such as change notifications and deviations.
- Assess, consolidate, and monitor resource needs and timelines for assigned projects and ensure resources are accurately reflected in the planning systems.
- Ensure DP development is compliant with quality principles and cGMP practice and coordinate timely delivery of high-quality source documents for HA submissions.
- Review regulatory documents, provide content to answer HA questions or Investigator Brochure, and stay at the forefront of scientific and technical trends in the discipline.
- University degree in biotechnology, pharmaceutical technology, or similar discipline.
- 5-6 years (BS), 2-4 years (MS), or 0-3 years (PhD) of related experience with pharmaceutical development (Drug Product).
- Thorough understanding of development processes, good knowledge of state-of-the-art technology/equipment, and knowledge of related basic regulations.
- Project excellence: navigating through complexity and ambiguity, strong communication and presentation, organization, and planning skills, excellent time management and planning abilities, inclusive in decision-making, strong leadership skills in a matrix setup.
- Operational excellence: demonstrates cross-functional problem-solving, critical data evaluation, continuous improvement mindset, advanced coaching, and proven leadership skills.
- Organizational Savvy: understanding organizational structures, working practices, and strategy, inclusive and collaborative across disciplines and geographies, excellent networking and relationship building.
- Stakeholder engagement: excellent communication, negotiation, and interpersonal skills, ability to work in interdisciplinary and cross-cultural teams, confident in managing expectations and conflict management.
- Business mindset: strategic thinking and planning, confident with risk management, including quality and safety, resources, and budget planning.
- Vision and Purpose: a role model to the functional team for creating a shared purpose, priorities, and objectives setting.
-
Cambridge, Massachusetts, United States Bristol-Myers Squibb Full timeJob 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...
-
Cambridge, Massachusetts, United States Bristol-Myers Squibb Full timeJob SummaryBristol-Myers Squibb is seeking an experienced Associate Director, Drug Development Project Management to join our team. This role will be responsible for leading the strategic and operational planning and decision-making process with a BMS Global Program Team (GPT) in early and/or late development.Key ResponsibilitiesPartner with the Global...
-
Cambridge, Massachusetts, United States Bristol-Myers Squibb Full timeJob SummaryBristol-Myers Squibb is seeking an experienced Associate Director, Drug Development Project Management to join our team. 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...
-
Cambridge, Massachusetts, United States Bristol-Myers Squibb Full timeJob 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, Drug Substance Development
3 days ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob SummaryAkebia 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...
-
Principal Scientist, Drug Product Development
3 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob Title: Principal Scientist, Drug Product DevelopmentAkebia Therapeutics is seeking a highly skilled Principal Scientist to join our CMC Technical Operations team. As a key member of our team, you will provide strategic and technical leadership in the development and execution of drug product strategies for our clinical and commercial programs.Key...
-
Senior Director, Drug Substance Development
3 days ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob 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...
-
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. As a key member of our regulatory affairs team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products, with a focus on Material...
-
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob OverviewWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda Pharmaceutical. This role will be responsible for leading the development and implementation of innovative regulatory strategies for CMC, Device and Drug-Device Combinations Material Sciences.Key ResponsibilitiesDevelop and implement...
-
Senior Director of Formulation Development
4 weeks ago
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob 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 timeJob 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 Stratacuity: Proven Scientific Placement Full timeJob 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...
-
Cambridge, Massachusetts, United States Third Rock Ventures Full timeA Third Rock Ventures is seeking a Formulations Scientist and Drug Product Lead to establish core operations of a new team. This position will be a laboratory-based role, offering opportunities to advance programs, develop new workflows, implement devices, and build a laboratory. Successful candidates will be innovative, thrive in a startup environment, and...
-
Senior Director of Formulation Development
4 weeks ago
Cambridge, Massachusetts, United States Stratacuity: Proven Scientific Placement Full timeJob 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...
-
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda is a forward-thinking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients worldwide. We are seeking a Senior Director and Regulatory Platform Lead to join our team in Cambridge, MA.Key ResponsibilitiesDevelop and implement innovative regulatory strategies for device and combination...
-
Cambridge, Massachusetts, United States Takeda Pharmaceutical Full timeJob DescriptionTakeda is seeking a Senior Director and Regulatory Platform Lead for CMC, Device and Drug-Device Combinations Material Sciences to join our team. As a key member of our regulatory team, you will be responsible for developing and implementing innovative regulatory strategies for pure device and combination product submissions, with a focus on...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Cambridge, Massachusetts, United States Takeda Full timeJob SummaryWe are seeking a highly experienced Senior Director and Regulatory Platform Lead to join our team at Takeda. As a key member of our regulatory team, you will be responsible for leading the development and implementation of innovative regulatory strategies for device and combination products.Key ResponsibilitiesDevelop and implement global...
-
Principal Scientist, Drug Product Development
4 weeks ago
Cambridge, Massachusetts, United States Akebia Therapeutics Full timeJob SummaryAkebia Therapeutics is seeking a highly skilled Principal Scientist to join our CMC Technical Operations team. As a key member of our team, you will provide strategic and technical leadership in the development and optimization of our clinical and commercial programs.Key ResponsibilitiesProvide pre-formulation process characterization, formulation...
