Director, Microbial Process Development

3 weeks ago

Boston, United States HireMinds Full time

Director, Bioprocess Development

Boston, MA

Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily responsible for scientific leadership and technical oversight of upstream and downstream process design, development, and scalability of unit operations necessary for supporting the Target product profile of the vaccine candidates in development. This role is within a team of highly experienced scientists with an opportunity to drive IND submission of early-stage assets. As a CMC development lead, the individual will apply their strong expertise in CMC fermentation and/or purification to develop robust, phase-appropriate processes for drug substance GMP production to enable human clinical studies and eventual licensure. This position is an onsite role in a lab-based function. To be successful candidates must enjoy and thrive in an onsite, highly collaborative lab environment with daily face-to-face cross-functional interactions between scientists.

Responsibilities include but are not limited to:

  • Effectively function as a CMC lead generating original technical ideas and development strategies.
  • Provide scientific and technical leadership of early-stage assets to design and develop scalable upstream and downstream processes using QbD and PAT tools.
  • Responsible for development, characterization, scale-up and support of drug substance processes to enable advancement of programs.
  • Develop robust CMC development plans, Apply established platform approaches and problem-solving skills to rapidly tackle drug substance challenges and build robust processes with efficient experimentation
  • Expand and develop skills in microbial fermentation, scale up and purification, thereby further contributing to the integrated group.
  • Participate in drug substance teams and collaborate cross functionally with analytical and drug product representatives to deliver drug substance manufacturing processes in a phase appropriate manner.
  • Make significant contributions to project team through lab-based activities.
  • Proactively seek out new tools, techniques, and strategies to implement into individual programs(s)
  • Be hands-on and execute lab and small-scale operations to meet project deliverables.
  • Transfer processes to GMP manufacturing.
  • Write technical publications, reports, presentations, and regulatory filings including publishing research in peer-reviewed journals and presenting work at scientific conferences.
  • Work efficiently, collaboratively, and cross-functionally toward project timelines and goals.
  • Deliver process amenable to cGMP operation and carry out results of drug substance in a cGMP manufacturing environment.
  • Provide technical recommendations for evaluating process data, troubleshooting and root cause analysis as well as providing strategic recommendations leading to improved yields, cost of goods and process robustness.
  • Identify and lead additional development activities and manufacturing through various phases of product development.
  • Participate in efforts to define, manage, and/or complete innovation projects that advance technical capabilities, refine & establish platform manufacturing processes.
  • Generate documentation for experimental reports to support technology transfer and regulatory filings (development and technical report writing).
  • Communicate technical information and project progress to the Senior leadership and external partners.
  • Mentor/supervise a team of one or more and evaluate the performance of those individuals; is accountable for the effective performance of the team/individuals.

Preferred Qualifications:

  • Must be a subject matter expert in microbial fermentation (yeast). Additional experience in downstream purification of biologics including chromatography separations and filtration operations (depth, dead-end, and ultrafiltration/diafiltration) is a plus.
  • Direct experience in designing, planning and executing feed strategies for increased yield and productivity,
  • Proficiency in Mandarin
  • Strong understanding of analytical techniques using HPLC, ELISA and mass spectrometry based methods

Requirements:

  • PhD in Chemical/Biochemical Engineering, Biochemistry, Chemistry or Biology with a minimum of 8 years in the bio/pharmaceutical manufacturing environment. MS with 10+ years of relevant experience in MSAT or process development of biologics /vaccines may also be considered.
  • Direct experience in microbial expression systems (yeast) is a must.
  • Technical expertise in development and full-scale manufacture of recombinant biologic products. Direct experience in Vaccine development and Phase 1-3 readiness support is highly desirable.
  • Excellent communication skills, both written and oral.
  • Proficiency in statistical software for data analysis and tracking and trending.
  • Other:
  • Seeking Boston local candidates to be on-site 3-4 days per week.
  • Travel (5-10%) may be required to CMO, CRO and key vendor for process and product development purposes.

  • Director, Microbial Process Development

    1 month ago

    Boston, United States HireMinds Full time

    Director, Bioprocess Development Boston, MA Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...

  • Director, Microbial Process Development

    2 months ago

    Boston, United States HireMinds Full time

    Director, Bioprocess Development Boston, MA Our vaccine client in Boston, MA is looking to add a hands-on, Director, Bioprocess Development (Microbial/Fermentation) to their team! This role will work on-site, in the lab to lead the development of scalable processes for CMC development of its early-stage clinical programs. The Director will be primarily...

  • Associate Director/Director Upstream Process Development

    2 weeks ago

    Boston, United States Page Mechanical Group Inc Full time

    Position: Associate Director/Director Upstream Process Development & Technical Operations Department: Technical Operations Reporting to: Sr. Director Technical Operations Location: Remote Summary: The Associate Director/Director Upstream Process Development and Technical Operations will be directly responsible for the process development and technical...

  • Director of Process Piping

    3 days ago

    Boston, United States gpac Full time

    Looking for an experienced Director of Process Piping. As Director, you will report to the COO and be charged with building and growing a Process Piping Division, you will play a pivotal role in establishing and expanding the company’s presence in the process piping market. Your primary responsibility will be to lead and manage all aspects of the...

  • Director, Development Systems

    3 weeks ago

    Boston, United States Xenon Pharmaceuticals Inc. Full time

    Director/Senior Director, Development Systems Boston, MA, USA Req #195 Friday, March 8, 2024 Who We Are: Who We Are: Xenon Pharmaceuticals (NASDAQ:XENE ) is a neuroscience-focused biopharmaceutical company committed to discovering, developing, and commercializing innovative therapeutics to improve the lives of people living with neurological and psychiatric...

  • Director of Development

    4 weeks ago

    Boston, United States RIVET Full time

    As RIVET’s Director of Development, you will translate our compelling mission focused on providing micro-grants to youth innovators in “capital deserts” around the globe into significant philanthropic support from high networth individuals, family offices, and foundations.  You will be responsible for three work streams pertaining...

  • Director of Development

    2 weeks ago

    Boston, United States Access Philanthropy Full time

    As RIVET’s Director of Development, you will translate our compelling mission focused on providing micro-grants to youth innovators in “capital deserts” around the globe into significant philanthropic support from high networth individuals, family offices, and foundations. You will be responsible for three work streams pertaining to fundraising:...

  • Director of Development

    1 month ago

    Boston, Massachusetts, United States RIVET Full time

    As RIVET's Director of Development, you will translate ourcompelling mission focused on providing micro-grants to youthinnovators in "capital deserts" around the globe into significantphilanthropic support from high networth individuals, familyoffices, and foundations. You will be responsible for three work streams pertaining tofundraising: Strategy: As...

  • Director of Development

    3 days ago

    Boston, Massachusetts, United States RIVET Full time

    As RIVET's Director of Development, you will translate ourcompelling mission focused on providing micro-grants to youthinnovators in "capital deserts" around the globe into significantphilanthropic support from high networth individuals, familyoffices, and foundations. You will be responsible for three work streams pertaining tofundraising: Strategy: As...

  • Director of Development

    1 month ago

    Boston, United States KLR Executive Search Group LLC Full time

    KLR Executive Search Group is pleased to partner with Habitat for Humanity Greater Boston, leading the search for their next Director of Development. Habitat for Humanity Greater Boston (Habitat Greater Boston) was incorporated as a Massachusetts non-profit in 1987. Since then, it has built more than 120 homes in the neighborhoods of Dorchester, Roxbury,...

  • Director of Development

    3 days ago

    Boston, United States KLR Executive Search Group LLC Full time

    KLR Executive Search Group is pleased to partner with Habitat for Humanity Greater Boston, leading the search for their next Director of Development. Habitat for Humanity Greater Boston (Habitat Greater Boston) was incorporated as a Massachusetts non-profit in 1987. Since then, it has built more than 120 homes in the neighborhoods of Dorchester, Roxbury,...

  • Development Director

    1 month ago

    Boston, United States Chinese Consolidated Benevolent Asn Full time

    CCBA Development Director | Job Title: Development Director | Weekly Hrs: 40 | Reports to: CCBA Board of Directors | Date: 4/3/2024 The Chinese Consolidated Benevolent Association of New England, Inc. (CCBA of New England) seeks a new Development Manager. Our Organization and Community: Incorporated in 1923, the Chinese Consolidated Benevolent Association of...

  • Development Director

    1 month ago

    Boston, United States CHINESE CONSOLIDATED BENEVOLENT ASN Full time

    Job DescriptionJob DescriptionCCBA Development Director | Job Title: Development Director | Weekly Hrs: 40| Reports to: CCBA Board of Directors | Date: 4/3/2024The Chinese Consolidated Benevolent Association of New England, Inc. (CCBA of New England) seeks a new Development Manager.Our Organization and Community:Incorporated in 1923, the Chinese Consolidated...

  • Development Director

    3 days ago

    Boston, United States CHINESE CONSOLIDATED BENEVOLENT ASN Full time

    Job DescriptionJob DescriptionCCBA Development Director | Job Title: Development Director | Weekly Hrs: 40| Reports to: CCBA Board of Directors | Date: 4/3/2024The Chinese Consolidated Benevolent Association of New England, Inc. (CCBA of New England) seeks a new Development Manager.Our Organization and Community:Incorporated in 1923, the Chinese Consolidated...

  • Development Director

    2 weeks ago

    Boston, United States Next City Full time

    Our Mission: Hearth is a non-profit organization dedicated to the elimination of homelessness among the elderly. This mission is accomplished through a unique blend of prevention, placement, and housing programs all designed to help elders find and succeed in homes of their own. To this end, all housing operated by Hearth provides a creative array of...

  • Business Development Director

    1 week ago

    Boston, United States Citron Hygiene Full time

    Great companies start with great people that share a common mission! We are looking for experienced business developers that share our passion to foster equity and diversity within our customer's workplace and the surrounding communities they serve.Citron Hygiene is first and foremost a service business specializing in raising restroom standards and...

  • Business Development Director

    3 weeks ago

    Boston, United States Citron Talent Acquisition Team Full time

    Great companies start with great people that share a common mission! We are looking for experienced business developers that share our passion to foster equity and diversity within our customer’s workplace and the surrounding communities they serve. Citron Hygiene is first and foremost a service business specializing in raising restroom standards and...

  • Development Director

    1 month ago

    Boston, United States CHINESE CONSOLIDATED BENEVOLENT ASN Full time

    Job DescriptionJob DescriptionCCBA Development Director                  | Job Title: Development Director | Weekly Hrs: 40 | Reports to:  CCBA Board of Directors | Date: 4/3/2024 The Chinese Consolidated Benevolent Association of New England, Inc. (CCBA of New England) seeks a new Development Manager.  Our Organization and...

  • Development Director

    3 days ago

    Boston, United States CHINESE CONSOLIDATED BENEVOLENT ASN Full time

    Job DescriptionJob DescriptionCCBA Development Director                  | Job Title: Development Director | Weekly Hrs: 40 | Reports to:  CCBA Board of Directors | Date: 4/3/2024 The Chinese Consolidated Benevolent Association of New England, Inc. (CCBA of New England) seeks a new Development Manager.  Our Organization and...

  • Associate Director, Quality Sterility Assurance and Aseptic Controls

    2 weeks ago

    Boston, United States Vertex Pharmaceuticals, Inc Full time

    Job Description GENERAL POSITION SUMMARY The Associate Director of Quality Sterility Assurance and Aseptic Controls is recognized as having expertise in the principals and application of sterile processing technologies and providing technical support for manufacturing of cell and gene therapy programs within cGMP manufacturing. This role will partner with...