Director of Drug Product Development

2 months ago

Fremont, California, United States Bayside Solutions Full time

Senior Director, Drug Product

Direct Hire Full-Time Role

Salary Range: $224,600 - $245,000 per year

Location: Redwood City, CA - Hybrid Role

Position Overview:

This pivotal role serves as the technical authority for drug product development and CMC project leadership. The incumbent will spearhead drug product development initiatives that lead to NDA submissions and market entry, while formulating and executing the CMC strategy. You will offer both technical guidance and project leadership, collaborating with diverse stakeholders to ensure that pharmaceutical drug product development and CMC tasks are carried out efficiently and in accordance with the integrated product development framework and timelines.

Key Responsibilities:

  • Oversee drug product development efforts to transition new chemical entities (NCE) from preclinical optimization to market readiness.
  • Manage pre-formulation, final formulation selection, formulation and process development, clinical manufacturing, scale-up, technology transfer, process optimization, and validation for solid oral dosage forms and parenteral products.
  • Develop and implement strategies for technical activities linked to product development and manufacturing, supporting clinical development, regulatory submissions (IND/NDA/MAA), and product approvals.
  • Design and supervise QbD and risk-based studies, along with process development activities in preparation for registration, validation, and commercialization.
  • Draft and review technical documentation and CMC-related materials required for regulatory submissions.
  • Build and sustain a high-performing team to support ongoing projects.
  • Provide strategic and technical oversight of internal teams and Contract Manufacturing Organizations (CMOs).
  • Lead cross-functional CMC teams for assigned projects to ensure effective development and execution of CMC plans and strategies.
  • Act as a core team member, communicating CMC strategies and project updates to key stakeholders across functions, and facilitate decision-making processes.
  • Collaborate with various teams (process R&D, analytical development, supply chain, quality, clinical, regulatory, DMPK, and toxicology) to achieve CMC and program objectives.
  • Travel to CDMOs for vendor evaluation and manufacturing oversight as necessary.

Qualifications:

  • A PhD (or minimum MSc) in Pharmaceutics, Chemistry, Chemical Engineering, or a related discipline is preferred.
  • 18+ years of experience in the pharmaceutical or biotech sector, demonstrating a strong record of technical proficiency, leadership, and experience in both early and late-phase drug product development for small molecules.
  • Proven project and cross-functional team leadership capabilities along with effective people management skills.
  • Experience in late-stage product development, scale-up, technology transfer, and process optimization for solid oral dosage and parenteral formulations is advantageous.
  • Comprehensive understanding and practical experience with pharmaceutical drug products in relation to GMP, quality systems, ICH guidelines, FDA, EMA, and relevant regulatory standards.
  • Extensive background in late-phase drug product development and commercial progression with CMC regulatory submissions for the US (NDA), Europe (MAA), Japan, and China.
  • Exceptional problem-solving abilities with strategic and technically sound decision-making skills.
  • Excellent written and verbal communication skills, along with strong interpersonal abilities.
  • Innovative team player with a high level of energy suitable for a dynamic corporate environment.

Desired Skills and Experience:

Pharmaceutical Development, late-phase drug development, CMC, small molecule, GMP, ICH, FDA, EMA, New Drug Application.

Bayside Solutions, Inc. may collect your personal information during the position application process. Please reference Bayside Solutions, Inc.'s CCPA Privacy Policy at

  • Senior Director, Drug Product Development

    1 month ago

    Fremont, California, United States Bayside Solutions Full time

    Job SummaryWe are seeking a highly experienced Senior Director, Drug Product to lead our drug product development activities and CMC project lead. This role will be responsible for advancing new chemical entities from preclinical lead optimization to commercialization, while ensuring seamless execution of pharmaceutical drug product development and CMC...

  • Senior Director, Drug Product Development

    1 month ago

    Fremont, California, United States Bayside Solutions Full time

    Job SummaryWe are seeking a highly experienced Senior Director, Drug Product to lead our drug product development activities and CMC project lead. This role will be responsible for drug product development activities leading to NDA submission and commercialization, and development and execution of the CMC strategy.Key ResponsibilitiesLead drug product...

  • Senior Director, Pharmaceutical Product Development

    4 weeks ago

    Fremont, California, United States Bayside Solutions Full time

    Job SummaryBayside Solutions is seeking a highly experienced Senior Director to lead our drug product development activities. As the technical lead and CMC project lead, you will play a critical role in advancing new chemical entities from preclinical lead optimization to commercialization.Key ResponsibilitiesLead Drug Product Development: Advance new...

  • Director of Development

    1 month ago

    Fremont, California, United States Info Way Solutions Full time

    Job Title: Director of DevelopmentWe are seeking a seasoned technology leader to join our team as a Director of Development. In this role, you will be responsible for influencing various infrastructure and domain capability teams to build APIs/tools for 3P developer needs.Key Responsibilities:Influence teams across the organization to champion for 3P...

  • Business Development Director

    2 weeks ago

    Fremont, California, United States Lam Research Full time

    About the RoleLam Research is seeking a highly experienced Business Development Director to join our Global Customer Operations Group. As a key member of our team, you will be responsible for developing strategic market and product line business plans, identifying volume and strategic customers, and building long-term relationships with new and existing...

  • Senior Quality Control Director

    2 weeks ago

    Fremont, California, United States Bionova Scientific Inc Full time

    Job Title: Senior Quality Control DirectorBionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization.Job Summary:The Senior Quality Control Director will be responsible for ensuring the success of our analytical laboratories through strategic and tactical...

  • Senior Quality Control Director

    1 month ago

    Fremont, California, United States Bionova Scientific Inc Full time

    Job Title: Senior Quality Control DirectorBionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization.Job Summary:The Senior Quality Control Director will be responsible for ensuring the success of Bionova Scientific's analytical laboratories through strategic...

  • Senior Quality Control Director

    2 weeks ago

    Fremont, California, United States Bionova Scientific Inc Full time

    Job SummaryBionova Scientific Inc is seeking a highly experienced Senior Quality Control Director to lead our analytical laboratories across the entire CDMO organization. As a key member of our Quality and Compliance team, you will be responsible for ensuring the success of our analytical laboratories through strategic and tactical leadership.Key...

  • Product Director

    1 week ago

    Fremont, California, United States UL Solutions Full time

    Product Manager Job DescriptionOverviewWe are seeking a highly skilled Product Manager to lead the development of our Batteries & ESS Storage and Industrial e-Mobility products. The successful candidate will have a strong background in product management, with experience in defining and executing product strategies.Key Responsibilities* Develop and execute...

  • Zone Director

    2 weeks ago

    Fremont, California, United States Ardelyx Full time

    Job Title: Zone DirectorArdelyx is a commercial biopharmaceutical company dedicated to discovering, developing, and commercializing innovative medicines that address significant unmet medical needs. We are seeking a highly experienced Zone Director to lead our sales team in a geographically defined Zone.Key Responsibilities:Hire, train, and develop Area...

  • Regulatory Affairs Director

    2 weeks ago

    Fremont, California, United States Scribe Therapeutics Full time

    Job Title: Associate Director/Director, Regulatory AffairsScribe Therapeutics is a molecular engineering company focused on creating best-in-class in vivo therapies that permanently treat the underlying cause of disease. Our team is passionate about developing custom engineered enzymes and delivery modalities as part of a proprietary, evergreen CRISPR by...

  • Zone Director

    2 weeks ago

    Fremont, California, United States Ardelyx Full time

    Job Title: Zone DirectorArdelyx is a commercial biopharmaceutical company dedicated to discovering, developing, and commercializing innovative first-in-class medicines that address significant unmet medical needs.About the Role:The Zone Director will be responsible for leading a high-performing sales team within a geographically defined Zone to drive sales...

  • Product Development Engineer

    3 weeks ago

    Fremont, California, United States TE Connectivity Full time

    Job OverviewTE Connectivity's R&D/Product Development Engineering Teams are responsible for conceiving original ideas for new products, introducing them into practice, and ensuring their successful development and qualification from market definition through production and release.Key ResponsibilitiesDevelop and implement product development strategies,...

  • Product Development Engineer

    2 weeks ago

    Fremont, California, United States Abbott Full time

    Product Development Opportunities at AbbottAbbott is a global healthcare leader that helps people live more fully at all stages of life. Our portfolio of life-changing technologies spans the spectrum of healthcare, with leading businesses and products in diagnostics, medical devices, nutritionals, and branded generic medicines.As a Product Development...

  • Sales Director Compound Semiconductor Products

    2 weeks ago

    Fremont, California, United States Vital Chemicals USA LLC Full time

    Job OpportunityWe are seeking a seasoned Sales Director to lead our Compound Semiconductor Business Unit in the Bay Area, California. The ideal candidate will formulate and implement a sales strategy to drive growth, working closely with our Management Team to meet and exceed revenue targets.Key Responsibilities:Develop and execute a sales strategy for the...

  • Product Development Manager

    4 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Product Manager Job DescriptionWe are seeking a highly skilled Product Manager to join our team at Info Way Solutions LLC in Fremont, CA.Key Responsibilities:Develop and enhance products by managing product roadmaps, aligning business and technical needs, analyzing customer and product data, and turning customer insights into actionable initiatives.Define...

  • Product Development Manager

    3 weeks ago

    Fremont, California, United States Info Way Solutions Full time

    Product Manager Job DescriptionWe are seeking a highly skilled Product Manager to join our team at Info Way Solutions LLC in Fremont, CA.Key Responsibilities:Develop and enhance products by managing product roadmaps, aligning business and technical needs, analyzing customer and product data, and turning customer insights into actionable initiatives.Define...

  • Product Development Engineer

    4 weeks ago

    Fremont, California, United States TE Connectivity Full time

    Job Title: R&D/Product Development EngineerAt TE Connectivity, we are seeking a highly skilled R&D/Product Development Engineer to join our team. As a key member of our engineering team, you will be responsible for conceiving original ideas for new products, introducing them into practice, and ensuring their successful development and qualification.Key...

  • Product Development Engineer

    1 month ago

    Fremont, California, United States Lam Research Full time

    About the RoleWe are seeking a highly skilled Product Engineer to join our Global Products Group at Lam Research. As a Product Engineer, you will play a critical role in driving product development at the forefront of the semiconductor equipment industry.Key ResponsibilitiesCollaborate with cross-functional teams to guide the specification and development of...

  • Product Development Engineer

    1 month ago

    Fremont, California, United States Lam Research Full time

    About the RoleWe are seeking a highly skilled Product Engineer to join our Global Products Group at Lam Research. As a Product Engineer, you will play a critical role in driving product development at the forefront of the semiconductor equipment industry.Key ResponsibilitiesCollaborate with cross-functional teams to guide the specification and development of...