CMC Strategy Leader for Biologics & Cell/Gene Therapies
VCLS
VCLS is seeking a strategic Head of Chemistry, Manufacturing, and Controls (CMC) to define and execute global CMC strategy across biologics, oligonucleotides, combination products, and cell & gene therapies. You will lead phase-appropriate programs from early development through regulatory readiness, partnering with Regulatory, clinical, and business teams. You will shape manufacturing and analytical strategies, oversee IND/CTA/BLA/NDA/MAA/IMPD documentation, and mentor a 5–10 person team to #J-18808-Ljbffr VCLS
- ...of Chemistry, Manufacturing, and Controls to lead the development and execution of global CMC strategy across a diverse therapeutic portfolio including biologics and gene therapies. The successful candidate will exhibit strong drug development expertise, cross-...Suggested
- ...seeking a Senior Manager/Associate Director for Global Regulatory Affairs CMC in Boston, MA. This key position involves supporting regulatory strategy and execution for innovative biologic therapies. The ideal candidate will have extensive experience in regulatory...Suggested
- ...Consulting SARL is seeking a Senior Director of US Regulatory Strategy in Boston to lead regulatory guidance for biotech and... ...strategic oversight of BLA submissions, with a focus on complex biologics and therapies, emphasizing strong client relationships and business...Suggested
$110k - $125k
...Description Group Leader (Lab Supervisor) – Cell and Gene – Cell Based Assay... ...of life-changing therapies. With clinical... ...program timelines and CMC milestones. Data... ...team to align testing strategies and support program... ..., Immunology, Biology, Molecular Biology...SuggestedRemote jobFull timeContract workTemporary workWork at officeRelocationRelocation packageMonday to FridayShift workNight shiftWeekend workDay shiftAfternoon shift$295k - $372.87k
...genetic medicine company focused on advancing a portfolio of gene therapy candidates targeting rare neuromuscular and cardiac diseases,... ...of the company’s comprehensive U.S. and Global market access strategy. This individual will play a key leadership role in preparing...SuggestedTemporary workFlexible hours- Otsuka America Pharmaceutical Inc. is seeking a Senior Manager, CMC Data Analytics in Boston, Massachusetts. This role involves executing data-driven integration and analysis to support biologics development from IND-enabling studies to commercialization. The ideal candidate...
- Vertex Pharmaceuticals Inc (US) in Boston is seeking a Salesforce Technical Architecture & Strategy Lead to enhance the Vertex Connects Portal for Cell and Gene Therapy. This key role involves leading platform architecture and collaborating with cross-functional teams to...Flexible hours
$197.03k - $238.75k
Bristol Myers Squibb is seeking an Area Business Manager for Cell Therapy in Boston to lead the account management team. This role involves defining account strategies to achieve commercial objectives and collaborating with stakeholders. The ideal candidate should have...- ...Summary You will lead Chemistry, Manufacturing, and Controls (CMC) regulatory strategy and execution for mature vaccine projects in the U.S.... ...liaison in the U.S. for FDA communications. CMC experience for biologics, including regulatory requirements and technical content...Local area
- ...in Boston is seeking a Principal Scientist in Stem Cell Research. This hands-on role involves leadership in... ...significant post-doctoral experience in stem cell biology, demonstrating expertise in experimental strategy and team leadership. A competitive salary and generous...
- Job Title: CMC Demand & Supply Leader Location: Framingham, MA About the Job... ...Leader is to integrate Project Strategy, Clinical and CMC... ...Microbiology, Immuno‑inflammation, Gene Therapy, Rare Diseases,... ..., Biochemistry, Molecular Biology, Biotechnology, Biomedical...
$228k - $330k
Flagship Pioneering in Cambridge, MA is in search of an Executive Director or Vice President, CMC. This senior leadership role is crucial to driving portfolio-level CMC strategy across multiple programs, requiring a robust blend of scientific knowledge and operational...$204k - $292k
Repertoire-Immune-Medicines is seeking a Vice President, Head of CMC in Cambridge, MA. This role involves leading all CMC activities for protein biologics, establishing CMC strategy, and managing external partnerships. Candidates must have a PhD and 15+ years in biotechnology...$240k - $360k
...for Cystic Fibrosis (CF), Casgevy, a gene therapy for sickle cell disease and beta-thalassemia and Journavx... ...Director of Global Value & Access Strategy (GVAS) for povetacicept, reporting to... ...to developing the next generation of leaders. They will also manage two direct...Summer workRemote workWorldwideFlexible hours2 days per week- ...Director of Market Access Marketing to shape U.S. reimbursement and payer access for the portfolio, including PMO and gene therapies. You will lead payer strategy, create value propositions, and present recommendations to executives to drive coverage and adoption....
- ...to discover and develop therapies that take aim at... ...such as tumor suppressor gene loss and their contribution... ...the ability of cancer cells to evade immune cell killing... ...a Clinical Trial Leader (CTL) to lead cross-functional... ...of mitigation strategies and action plans. Ensure...Interim role
$213k - $280.5k
A leading biotech company is seeking a Senior Director of Biology to lead biological strategy and target validation. Applicants should possess a PhD in a relevant field, with over 10 years of experience in target validation and relevant industry roles. The position involves...$130.8k - $209.4k
...seeking a Financial Planning and Analysis Lead in Cambridge, MA. This role involves leading financial planning and analysis for the CMC function, partnering closely to manage corporate forecasts and reporting. Candidates should have 5+ years of experience in finance, a...$238k - $374k
...seeking an Executive Director for Global Regulatory Affairs CMC Early Development based in Boston. The ideal candidate... ...strategic leadership, overseeing global CMC regulatory strategies for small molecules and biologics through Phase 2, and working with cross-functional...- Bristol-Myers Squibb is seeking an Area Business Manager for Cell Therapy in Boston to lead a dedicated account management team. This role focuses on driving revenue and ensuring a seamless patient experience while collaborating with various stakeholders. The ideal candidate...
$212k - $333.19k
...dedicated group of experienced biologic drug hunters with the... ...highly experienced leaders with proven track... ...scientists, AI/ML specialists, CMC partners and... ...IND filing Discovery strategy and implementation: Establish... ...display, hybridoma, single B cell), lead optimization,...Minimum wageFull timeTemporary workLocal areaRemote work$212k - $333.19k
...and delivers transformative therapies to patients. By focusing R&D... ...Regulatory Platform Lead GRA CMC, Device and Drug‑Device Combinations... ...product regulatory strategies particularly pertaining to the... ...influence and serve as a key opinion leader and resource within Takeda...Minimum wageFull timeTemporary workLocal areaRemote workWorldwideNight shift- ...biotechnology startup in Boston is looking for a Principal Scientist to lead CHO-based cell line development. In this role, you will conduct and supervise innovative cell line development for biologics, manage a team of scientists, and represent the company in external forums....
$200k - $250k
...to lead a team for the manufacturing of stem cell-derived pancreatic islet cells for type 1... ...successful candidate will have a BSc in Chemical, Biological, or Biomedical Engineering, with over 10 years of experience in cell therapy. The position offers a competitive salary...$130k - $230k
...technically rigorous Translational Biology Lead to advance programs and... ...the future of oncology therapies. This role spans both biomarker... ..., end-to-end translational strategies. This position reports to... ...to interact with senior leaders and external partners • Strong...Full timeImmediate startRemote work$238k - $374k
...dedicated group of experienced biologic drug hunters with the autonomy... ..., and evolve the program strategy for antibody, bispecific, fusion... ...based on scientific, clinical, CMC, and commercial considerations... ...display, hybridoma, single B cell), lead optimization, developability...Minimum wageTemporary workLocal areaRemote work$341.36k - $413.65k
...latest breakthroughs in cell therapy, this is work that... ...Summary: The Global Program Leader (GPL) and Franchise... ...end-to-end disease strategy, in partnership with Research... ...of basic biology, pharmaceutical optimization... ...chemistry/biochemistry, CMC), late development, and...Hourly payFull timeTemporary workPart timeFor contractorsSummer workLive inWork at officeLocal areaRemote workFlexible hoursShift work$66k - $99k
...Team Leader, Formulation Manufacturing As part of the Thermo... ...help clients deliver innovative gene therapies. We are placed at the... ...our leading and groundbreaking Cell and Gene Therapy business, enabling... ...: Chemistry, Biochemistry, Biology, Engineering or related scientific...Temporary workWork at officeRotating shift- Overview Job Title: CMC Demand & Supply Leader Location: Framingham, MA Within the CMC function, in the Global CMC Project Management department... ...(from R&D to LCM). The mission is to integrate Project Strategy, Clinical and CMC Operational plans for an early definition...
- Takeda is seeking an Associate Director, Patient Access Brand Strategy & Operations in Boston, MA to lead patient support programs and ensure seamless access to therapy in Dermatology. The ideal candidate will have over a decade of experience in patient services and operational...
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