Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products
4 weeks ago
This role is located in Cambridge, MA or RTP, NC.
The Head of Product Development and RegCMC, Biologics and Advanced Therapy Medicinal Products leadership role in PO&T is responsible for the process, analytical, and technology development of all biologic and advanced therapy medicinal product (ATMP) modalities including existing protein-based drugs, monoclonal antibodies, and gene therapy assets. The role has end-to-end CMC product responsibilities from pre-clinical to commercial life cycle process development activities, process platform strategies, and regulatory CMC management/filings across the biologics/ATMP modality portfolio. This role is ultimately accountable for delivering GMP-ready processes to manufacturing, phase-appropriate process optimization (i.e., COGS optimization), and regulatory CMC filing/approvability across all global healthcare regions. In addition to process and analytical development, the position oversees multi-disciplinary international teams supporting Quality oversight, CMO/CRO execution and strategy, regulatory filings, and manufacturing technology transfer. The leader guides, coaches, and develops team members to lead, collaborate, and engage in a matrix set of responsibilities with Biogen; this includes direct line reports as well as the facilitations of dotted line responsibilities of staff, and considerable partnership/alignment with Asset Development Program Management (ADPM) group.
This role sits on the PO&T leadership team, is the primary decision maker as a member of the PO&T Governance Committee (GC) for this modality, and has extensive interface and influence with critical stakeholders including Discovery & Research, Translational Sciences, and Clinical Development, external partners/collaborators representing PO&T on partner joint steering committees and various industry influencing forums.
Principle Accountabilities Include:
1. Sets the strategic direction and priorities to ensure development, delivery, life cycle, and regulatory management of programs/products in modality area of responsibility. Provides leadership, oversight, and direction to the cross-functional team responsible for the work.
2. Works cross-functionally to drive CMC strategy for products in modality area of responsibility. Identifies and resolves barriers associated with meeting CMC portfolio deliverables to ensure timelines are met. Develop CMC metrics/analytics to support decisions and development timelines. Represents PO&T in external due diligence and partnership evaluations
3. Contributes expertise to PO&T GC across the portfolio, particularly in assigned modality area. Establishes expert teams to support PO&T program or product strategy.
4. Leverages best CMC practices in the industry through professional forums and other external outreach; applies novel and forward-thinking ideas to influence Agencies.
5. Inspires others, develops and engages staff to leverage abilities, and builds a sense of belonging for the team. Manages synergy with line functions with regards to business/plan objectives, resources, and budget allocation in partnership with G&A.
-
Head of Product Development and Manufacturing
4 weeks ago
Cambridge, United States Volnay Therapeutics Full timeVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell...
-
Head of Product Development and Manufacturing
4 weeks ago
Cambridge, United States Volnay Therapeutics Full timeVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell...
-
Cambridge, United States Volnay Therapeutics Full timeVolnay, a rapidly growing biotech with a mission to unlock innovation in cell and gene therapies, is seeking a passionate and experienced Head of Product Development and Manufacturing to join our team. In this critical leadership role, you will be responsible for designing, developing, and implementing robust and scalable manufacturing processes for our cell...
-
Senior Scientist, Technical Development
3 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role Biogen is searching for a biophysicist to fill a Senior Scientist position within the Analytical Development (AD) – Biologics/Advanced Therapies & Medicinal Products (ATMP) department in Cambridge, MA. This key technical leadership role will lead the biophysical and higher-order-structure characterization for biologics...
-
Technical Product Manager
13 hours ago
Cambridge, United States VELSSON Technology Full timeThe Technical Product Manager is expected to possess a comprehensive understanding of the products and applications, showcasing the ability to effectively demonstrate their functionalities. Responsibilities encompass identifying and addressing the specific requirements of customers in Antibody Drug Discovery, Small Molecule Drug Development, Nucleic Acid...
-
Technical Product Manager
4 weeks ago
Cambridge, United States VELSSON Technology Full timeJob DescriptionJob DescriptionThe Technical Product Manager is expected to possess a comprehensive understanding of the products and applications, showcasing the ability to effectively demonstrate their functionalities. Responsibilities encompass identifying and addressing the specific requirements of customers in Antibody Drug Discovery, Small Molecule Drug...
-
Cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a talented formulation expert who is interested in joining a highly dynamic team. This position will offer a tremendous opportunity to lead formulation and DP manufacturing for a innovative portfolio of biologic medicines. Experience in design and scale-up of high concentration formulations for biotherapeutics...
-
Cambridge, United States Third Rock Ventures Full timeA Third Rock Ventures Stealth NewCo is seeking a talented formulation expert who is interested in joining a highly dynamic team. This position will offer a tremendous opportunity to lead formulation and DP manufacturing for a innovative portfolio of biologic medicines. Experience in design and scale-up of high concentration formulations for biotherapeutics...
-
Associate Director
2 days ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionAssociate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for treatment of rare respiratory diseases, including idiopathic pulmonary fibrosis (IPF) and progressive pulmonary fibrosis (PPF). Avalyn completed an oversubscribed $175M Series C...
-
Associate Director
2 days ago
Cambridge, United States Avalyn Pharma Inc Full timeJob DescriptionJob DescriptionBenefits:401(k) matchingCompany partiesCompetitive salaryDental insuranceHealth insuranceOpportunity for advancementPaid time offParental leaveStock options planVision insuranceWellness resources Associate Director / Director, Product Development Company Overview:Avalyn Pharma is developing innovative, inhaled therapies to...
-
Cambridge, United States Avalyn Pharma Inc Full timeBenefits: 401(k) matching Company parties Competitive salary Dental insurance Health insurance Opportunity for advancement Paid time off Parental leave Stock options plan Vision insurance Wellness resources Associate Director / Director, Product Development Company Overview: Avalyn Pharma is developing innovative, inhaled therapies to target the lungs for...
-
Research Fellow, Biologics Drug Discovery
2 weeks ago
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role The Biologics Drug Discovery group at Biogen is seeking a creative and self-motivated research fellow to contribute to our mission to design, optimize, and develop medicines to transform patients’ lives. The Research Fellow role at Biogen is an 18-month position designed to provide a unique opportunity for scientists to...
-
Head of Global Medical Affairs
3 weeks ago
Cambridge, Massachusetts, United States Bicycle Therapeutics Full timeJob Description The Head of Global Medical Affairs will provide strategic leadership to develop an integrated medical affairs strategy with a significant impact on Bicycle’s current and emerging programs. You will actively support clinical development activities, operating cross-functionally by engaging with the diverse teams across Bicycle including, but...
-
Senior Manager, Regulatory Affairs
2 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Cambridge, Massachusetts, United States Biogen Full timeJob Description About This Role As the Project Lead for Combination Product Engineering, you will join the Devices and Packaging Development team, specifically within the Medical Device group. Reporting to the Head of Human Factors & Device Strategic Operations, you will play a critical role in sustaining engineering strategies and processes, ensuring...
-
Senior Development Associate
2 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAs a member of the Process and Analytical Development (PAD) department, the Senior Development Associate contributes to Editas’s efforts to develop safe and effective cellular therapies using CRISPR-based gene editing technologies. Key Responsibilities and Accountabilities: Perform experimentation to develop cellular processes to support gene-edited cell...
-
Senior Director, In Vivo Therapeutics
4 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Director, Regulatory CMC
4 weeks ago
Cambridge, Massachusetts, United States Editas Medicine Full timeAt Editas, we’re driven by a collective purpose, to bring transformative and life changing therapies to people living with serious diseases with the greatest unmet needs. This fuels our drive to excel in scientific innovation, allowing us to harness the power and potential of CRISPR/Cas9 and CRISPR/Cpf1 (Cas12a) gene editing. We believe our people are at...
-
Cambridge, Massachusetts, United States Beam Therapeutics Full timePosition OverviewWe are seeking a motivated Scientist/Sr. Scientist to join our Analytical Research and Development team and perform method development and qualification for lot release and characterization of cell and gene therapy products and critical materials. S/he will work with a Beam's Analytical Development team to enable the rapid advancement of...
