Director of Biologics Development and Manufacturing

4 weeks ago


Boston, Massachusetts, United States AL Solutions Full time

Job Title: Senior Director/Executive Director CMC

About the Role:

At AL Solutions, we are seeking a highly experienced Senior Director/Executive Director CMC to lead our CMC teams in the development and optimization of protein biologics processes. This is a unique opportunity to utilize your CMC expertise to steer the nomination of Development Candidates and collaborate with CDMOs to craft contracts in partnership with Executive Leadership and Finance.

Key Responsibilities:

  • Build and lead CMC teams dedicated to the development and optimization of protein biologics processes.
  • Utilize your CMC expertise to steer the nomination of Development Candidates.
  • Select and collaborate with CDMOs; craft contracts in partnership with Executive Leadership and Finance.
  • Oversee the transfer and management of manufacturing processes with CDMOs, ranging from candidate nomination to process and analytical development, and advancing to early phase clinical manufacturing.
  • Facilitate the transfer and support of analytical methods at external CROs/CDMOs.
  • Direct analytical and stability programs at CROs to ensure the highest quality.
  • Prepare and review technical documents and reports essential for regulatory submissions.
  • Define and manage objectives, operating plans, production milestones, and overall goals for CDMO/CRO contracts.
  • Spot opportunities to expedite manufacturing processes to ensure timely clinical starts.

Requirements:

  • A Doctorate in Biochemistry, Biology, Bioengineering, Immunology, or a related discipline is required.
  • Minimum of 15 years of experience in the pharmaceutical and biotech sectors, with considerable management experience in the development and manufacturing of protein therapeutics.
  • Experience in technology transfer to Contract Development and Manufacturing Organizations (CDMOs) for both non-Good Manufacturing Practices (non-GMP) and Good Manufacturing Practices (GMP) manufacturing, encompassing cell line development, process development, and scale-up.
  • Expertise in the formulation of research strategies, operational management, and budgetary planning.
  • A profound understanding of the drug development lifecycle, with experience in research and clinical environments.
  • Proven ability to devise innovative solutions to achieve ambitious objectives and influence company direction.
  • Familiarity with bispecific protein products is preferred.
  • Skilled in the preparation of technical documentation for regulatory submissions.
  • Demonstrated leadership and personnel management capabilities, accompanied by effective communication across various functions.
  • Able to facilitate strategic discussions with senior management and external partners.
  • Willingness to travel both nationally and internationally to oversee relationships with CDMOs.

Benefits:

  • Health Care Plan (Medical, Dental & Vision)
  • Retirement Plan (401k, IRA)
  • Life Insurance (Basic, Voluntary & AD&D)
  • Paid Time Off (Vacation, Sick & Public Holidays)
  • Family Leave (Maternity, Paternity)
  • Short Term & Long Term Disability
  • Training & Development
  • Flexible on site schedule
  • Wellness Resources
  • Stock Option Plan


  • Boston, Massachusetts, United States Nucleus Biologics Full time

    About Nucleus Biologics:We are a leading provider of custom cell growth media, tools, and technologies that support every stage of development from research through commercialization.Our cell culture products and services fuel today's therapies and tomorrow's innovations.We are committed to delivering premium products and services through a transparent,...


  • Boston, Massachusetts, United States EPM Scientific Full time

    Job DescriptionAs a key member of our team, the Director of Downstream Process Development will be responsible for leading the development and optimization of downstream processes for the production of novel biologics. This role requires a strong understanding of chromatography, filtration, and process validation, as well as a strategic vision for developing...


  • Boston, Massachusetts, United States BioSpace, Inc. Full time

    Job SummaryWe are seeking a highly motivated and experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics.The ideal candidate will have a strong understanding of cGMP,...


  • Boston, Massachusetts, United States Vertex Pharmaceuticals Full time

    Job Summary:The Director, Regulatory CMC, Biologics will lead a team in the execution of global regulatory CMC strategies for investigational and marketed biologics products. This role is accountable for the preparation and filing of regulatory CMC submissions and managing interactions with Health Authorities for CMC topics.Key Responsibilities:Oversee the...


  • Boston, Massachusetts, United States AbbVie Full time

    Job SummaryAbbVie is seeking a highly experienced and skilled professional to lead our global technical support for a commercial biotherapeutic product. As a key member of our CMC Sciences team, you will be responsible for supporting global regulatory submissions, developing strategies for successful product launches, and driving process improvements and...


  • Boston, Massachusetts, United States Elektrofi Inc Full time

    Job Title: Executive Director, Head of Manufacturing Science and TechnologyElektrofi Inc is seeking a highly experienced and skilled Executive Director, Head of Manufacturing Science and Technology to lead our manufacturing operations. This role will be responsible for overseeing the development and implementation of manufacturing processes, ensuring...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the RoleTakeda is a forward-looking, world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. As a Director of AI Strategy for Biologics Innovation, you will lead the strategic application, integration, and development of machine learning and AI technologies in the discovery and development of...


  • Boston, Massachusetts, United States EPM Scientific Full time

    Job DescriptionAs the Director of Upstream Process Development, you will lead the design, optimization, and scale-up of upstream processes for biologics production, focusing on cell culture and fermentation technologies. This role will be pivotal in developing robust, scalable, and cost-efficient processes for the development of novel biologic therapeutic...

  • Medical Director

    3 weeks ago


    Boston, Massachusetts, United States Takeda Pharmaceuticals Full time

    Job SummaryTakeda Pharmaceuticals is seeking a highly skilled Medical Director to lead our Biologics Discovery team. As a key member of our organization, you will be responsible for analyzing, designing, and optimizing laboratory processes to improve efficiency, reduce costs, and enhance overall productivity.Key ResponsibilitiesEvaluate current laboratory...


  • Boston, Massachusetts, United States Takeda Pharmaceuticals Full time

    About the Role:Takeda Pharmaceuticals is seeking a highly skilled Director, Process Optimization, Global Biologics to join our team. As a key member of our Global Biologics organization, you will be responsible for analyzing, designing, and optimizing our lab and business processes to improve efficiency, reduce costs, and enhance overall productivity.You...


  • Boston, Massachusetts, United States Vertex Full time

    Job SummaryThe Chemistry Manufacturing Controls Associate Director at Vertex is responsible for executing global regulatory CMC strategies for investigational and marketed products. This role leads the preparation and filing of regulatory CMC submissions and manages interactions with Health Authorities for CMC topics. The Associate Director provides...


  • Boston, Massachusetts, United States BioSpace, Inc. Full time

    Job OverviewWe are seeking a highly experienced Associate Director to lead sterile drug product development and manufacturing activities. This role focuses on ensuring the highest quality standards and regulatory compliance for late-stage development to commercialization of biologics. The successful candidate will play a key role in vendor management and act...


  • Boston, Massachusetts, United States Takeda Pharmaceutical Full time

    About the Role:Takeda Pharmaceutical is a world-class R&D organization that unlocks innovation and delivers transformative therapies to patients. We are committed to the long-term strategy and vision to translate science into life-changing medicines that make critical differences for our patients around the world.The Global Biologics team within R&D is...


  • Boston, Massachusetts, United States Mentor Technical Group Full time

    Job DescriptionMentor Technical Group is a world leader in life science engineering and technical solutions, providing comprehensive support and solutions for the FDA-regulated industry.As a Biological Safety Cabinet and Incubator Specialist, you will be responsible for the installation, operation, cleaning, maintenance, and repair of biological safety...


  • Boston, Massachusetts, United States Unreal Gigs Full time

    At Unreal Gigs, we're seeking a talented Biological Data Analyst to join our team. As a key member of our computational biology group, you'll play a crucial role in developing innovative models and analytical tools that transform how we understand biological systems.Key Responsibilities:Develop computational models of biological processes, such as gene...


  • Boston, Massachusetts, United States Jobot Full time

    Job SummaryWe are seeking an experienced Associate Director of Quality Operations to join our team at Jobot. In this role, you will be responsible for providing laboratory QA support for our biologics commercial and clinical development programs.Key ResponsibilitiesVendor management of contract laboratories, including routine external meetings, coordination...


  • Boston, Massachusetts, United States RPM ReSearch Full time

    Job Title: Business Development Director Job Summary: The Director of Business Development will have the responsibility for growing, maintaining, and fostering sales in a regional territory. They will work as part of a team to help meet sales goals and work through a CRM to augment existing sales practices and methodologies. Our client offers preclinical...


  • Boston, Massachusetts, United States Jobot Full time

    Job DescriptionWe are seeking a highly experienced Senior Manager/Associate Director of Quality Operations to provide quality oversight for our biologics commercial programs.The ideal candidate will have a strong background in GMP quality and experience managing complex business relationships with QPs/EU business partners.Ensure CMO compliance with...


  • Boston, Massachusetts, United States Ginkgo Bioworks Full time

    Job DescriptionGinkgo Bioworks is seeking an experienced Associate Director, Alliance Management to join our Government Business Generation team. As a key member of our team, you will be responsible for building and managing Ginkgo's strategically important relationships with government partners.Key Responsibilities:Oversee a diverse and complex portfolio of...


  • Boston, Massachusetts, United States Verve Therapeutics, Inc. Full time

    Job Title: Director, gRNA Process DevelopmentVerve Therapeutics, Inc. is seeking a highly skilled and experienced Director, gRNA Process Development to join our Technical Operations team. As a key member of our team, you will be responsible for leading the development and implementation of gRNA process development strategies to support our novel gene editing...