Talent.com
Director/Sr. Director of Drug Product CMC
Director/Sr. Director of Drug Product CMCEPM Scientific • New York, NY, United States
Director / Sr. Director of Drug Product CMC

Director / Sr. Director of Drug Product CMC

EPM Scientific • New York, NY, United States
job_description.job_card.30_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Director / Sr. Director of Drug Product CMC

Location : New York City, NY

Company Overview :

We are partnered with a dynamic clinical-stage biotechnology company focused on developing innovative therapies to address unmet medical needs. They are dedicated to advancing science and improving patient outcomes across several treatments and therapies. Their portfolio consists of assets across early and late stage development.

Job Summary :

The Director / Sr. Director of Drug Product CMC will lead and oversees drug product development, manufacturing, and regulatory activities to ensure high-quality products are delivered from early development through commercialization. This role involves cross-functional collaboration to support product lifecycle management, process optimization, and regulatory compliance for drug products, ensuring all CMC strategies align with company goals and regulatory standards. The Director / Sr. Director will provide technical and strategic leadership, working closely with internal teams and external partners to meet critical project milestones.

Key Responsibilities :

  • Lead the development and implementation of CMC strategies for drug product development and manufacturing.
  • Oversee technology transfer to and from contract manufacturing organizations (CMOs) and provide technical oversight of drug product manufacturing.
  • Ensure compliance with cGMP regulations and manage quality assurance activities, including deviation management, batch record reviews, and lot disposition.
  • Develop and manage risk-based strategies for CMO oversight, considering product lifecycle, technical complexity, and CMO capabilities.
  • Collaborate with cross-functional teams, including Quality Assurance, Regulatory Affairs, Clinical Development, and Supply Chain, to ensure timely delivery of drug products.
  • Support regulatory submissions by providing CMC-related documentation and expertise.
  • Lead process optimization, validation, and continuous improvement initiatives.
  • Manage the drug product manufacturing budget and long-range planning.
  • Serve as a subject matter expert during regulatory inspections and audits.

Qualifications :

  • Ph.D. or Master's degree in Pharmaceutical Sciences, Chemistry, Chemical Engineering, or related field, with 10+ years of experience in CMC and drug product development (or equivalent industry experience for those with a Ph.D.).
  • Strong knowledge of cGMP regulations, ICH guidelines, and CMC content of regulatory submissions.
  • Proven track record in CMC regulatory submissions (IND, IMPD, NDA)
  • Experience managing CMOs and overseeing technology transfer processes.
  • Excellent problem-solving, project management, and communication skills.
  • Ability to work collaboratively in a fast-paced, dynamic environment.
  • Familiarity with quality-by-design (QbD) principles, statistical analysis, and DOE.
  • Willingness to travel as needed (up to 10%).

    • What We Offer :

  • Opportunity to lead in a dynamic, fast-growing company with a strong pipeline of innovative therapies.
  • Collaborative work environment with professional development and career growth opportunities.
  • Competitive compensation package, including comprehensive benefits and stock options.
    • serp_jobs.job_alerts.create_a_job

    Director Of Product • New York, NY, United States

    Job_description.internal_linking.related_jobs
    Director Trade Client Strategy - Synergie Medication Collective

    Director Trade Client Strategy - Synergie Medication Collective

    Blue Cross Blue Shield Association • New York, NY, United States
    serp_jobs.job_card.full_time
    The hiring range for this role is : .This is the lowest to highest salary we.A candidate's position within the.Note : No amount of pay is considered to be wages or compensation until such amount is ea...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Clinical Development Medical Director

    Clinical Development Medical Director

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Oversees the planning, execution, and interpretation of clinical trials research, data collection activities and clinical operations. Establishes and approves As the Clinical Development Medical Dir...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Medical Insights & Analytics - (4 roles)

    Director, Medical Insights & Analytics - (4 roles)

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    There are 4 Dir, Medical Insights & Analytics associated with this job posting.Dir, Medical Insights & Analytics, CRM.Dir, Medical Insights & Analytics, Immunology. Dir, Medical Insights & Analytics...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of CGT Commercial Enablement

    Director of CGT Commercial Enablement

    VirtualVocations • New York, New York, United States
    serp_jobs.job_card.full_time
    Director, Enterprise CGT, Commercial Enablement.Key Responsibilities Drive cross-functional CGT commercial strategies to support high-impact growth opportunities Serve as a strategic liaison bet...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Global Pharmacovigilance Medical Manager

    Global Pharmacovigilance Medical Manager

    Zoetis, Inc • Parsippany-Troy Hills, NJ, United States
    serp_jobs.job_card.full_time
    Zoetis is currently looking for a Global Pharmacovigilance Medical Manager to join our team.In this role you'll contribute to a Global Team with collective responsibility for regulatory activities ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, Clinical Pharmacology

    Director, Clinical Pharmacology

    Eisai • Nutley, NJ, United States
    serp_jobs.job_card.full_time
    At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care (hhc) mission.We're a growing pharm...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, Cell Therapy Drug Product Operations Risk Management

    Director, Cell Therapy Drug Product Operations Risk Management

    Bristol Myers Squibb • Summit, NJ, US
    serp_jobs.job_card.full_time
    Director, Cell Therapy Drug Product Operations Risk Management.Those aren't words that are usually associated with a job. But working at Bristol Myers Squibb is anything but usual.Here, uniquely int...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director of Drug Development

    Senior Director of Drug Development

    VirtualVocations • Astoria, New York, United States
    serp_jobs.job_card.full_time
    A company is looking for a Senior Director, Drug Product Development (Remote / Home Based).Key Responsibilities Directs the Small Molecule Drug Product Development team and manages budgetary resp...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Director, Formulations Development

    Director, Formulations Development

    Ovid Therapeutics • New York, NY, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Welcome! Ovid Therapeutics is a biopharmaceutical company developing medicines designed to conquer seizures with courageous science. We exist to serve and meaningfully improve the lives of peo...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days
    Pharma Product Business Development Director

    Pharma Product Business Development Director

    Geodis • Edison, NJ, US
    serp_jobs.job_card.full_time
    Pharma Product Business Development Director.GEODIS specializes in unlocking business value in a complex world, ensuring seamless movement of goods worldwide. As a global third-party logistics provi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Product Innovation Director

    Product Innovation Director

    Click Therapeutics • New York, NY, US
    serp_jobs.job_card.permanent
    As a leading innovator of Digital Therapeutics, Click delivers accessible, clinically proven, FDA-regulated prescription treatments to the smartphone in your hand. Click's treatments are defined by ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director, Program - Pharma

    Director, Program - Pharma

    Quest Diagnostics • Secaucus, NJ, US
    serp_jobs.job_card.full_time
    Focus on the core content of the job post, removing all extra metadata, navigation mentions, and redundant headers.Keep the content beautiful and high signal to noise ratio.serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Executive Director - Decision Science, Product Lead - Immunology

    Executive Director - Decision Science, Product Lead - Immunology

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The ideal location for this role is East Hanover, NJ but a distant working arrangement may be possible in certain states. Distant workers are responsible.East Hanover, NJ, as determined necessary by...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director, Key Account Management - Cell & Gene Therapy

    Director, Key Account Management - Cell & Gene Therapy

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    The Director of KAM leads management and growth of key client relationships mainly within the Cell & Gene Therapy (CGT) business segment. The role ensures seamless, value-driven client experience an...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Director / Senior Director Biostatistics

    Director / Senior Director Biostatistics

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    As the Director / Sr Biostatistics, you will influence and drive statistical strategy / innovation directly taking part in cross-functional collaboration and decision making for program(s) across multi...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of Product Development

    Director of Product Development

    VirtualVocations • Newark, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, Product Development (EMEA).Key Responsibilities Serve as the primary subject matter expert for regulatory intelligence and change management for designated pr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Director of IVD Assay Development

    Director of IVD Assay Development

    VirtualVocations • Elizabeth, New Jersey, United States
    serp_jobs.job_card.full_time
    A company is looking for a Director, IVD Assay Development.Key Responsibilities Lead the design and execution of development studies for colorectal cancer tests Oversee Analytical Validation (AV...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_1_day • serp_jobs.job_card.promoted
    Director, Platform Enablement RLT & RLI (US Medical) 2 of 2

    Director, Platform Enablement RLT & RLI (US Medical) 2 of 2

    Novartis Group Companies • East Hanover, NJ, United States
    serp_jobs.job_card.full_time
    Location : Remote : This position can be based remotely in US.Please note that this role would not provide relocation as a result. The expectation of working hours and travel (domestic and / or internat...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted