Director of Process Development

5 days ago

Redmond, United States SystImmune Inc. Full time
Director of Process Development

Redmond, WA

Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the tumor and/or to activate the immune system to attack the tumor.

Essential Duties and Responsibilities:

  • Provide expert technical leadership across Process Development, leading both strategic and day-to-day activities across upstream and downstream process development of proteins.
  • Oversee and manage process characterization and process validation studies, as well as technology transfer.
  • Lead the development of analytical strategy within a cross-functional team in support of clinical large molecules therapeutics programs. Establish phase-appropriate analytical development, characterization, and release strategies.
  • Manage CMO/CTL relationships to ensure development and qualification of appropriate analytical methods to enable analytical development, release, and stability testing at CMOs/CTLs.
  • Manage and execute fulfillment of material requests and material receiving to and from CMO, partners, domestic and international.
  • Work with protein engineering and immune-oncology (PE&IO) departments and cross-functional partners to build product understanding that serves as the foundation of the analytical strategy including establishing manufacturing feasibility, CQAs, and specifications throughout development.
  • Partner with manufacturing and QC and provide analytical development expertise required to support drug product release, characterization, and scaling.
  • Accountable for CMC analytical data- type, documentation, integrity, organization, and integration of datasets with cross functional partners for development purposes and regulatory submissions.
  • Identify appropriate CMOs, complete contract(s), and manage technology transfer to support scale-up and GMP manufacturing.
  • Compilation of CMC sections for IND and BLA submissions.
  • Lead or participate in Project and CMC development teams, as required
Education/ Experience qualifications:

- Education
  • Ph.D.in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or related field with at least 8+ years of laboratory experience in an industrial setting and with experience in CMC strategy and/or drug development.
  • M.S.in analytical sciences, biophysics, biochemistry, pharmaceutical sciences, or related field with at least 10+ years of laboratory experience in an industrial setting.
- Experience
  • Experience in CMC strategy and/or drug development.
  • Deep understanding of the design, development, optimization, and tech transfer of large molecule drug substance manufacturing processes.
  • Expertise in developing/optimization/troubleshooting/execution/tech transfer of biophysical and/or analytical methods for the following: reduced and non-reduced peptide mapping, intact LCMS, released glycans, HPLC/UPLC (including but not limited to RP-HPLC, SEC, HIC and IEX), CE and iCE (cIEF) SDS-PAGE, ELISA and other general biochemical analyses/methods for protein/mAb analysis
  • Expertise in quality attributes of therapeutic proteins with emphasis on chemical modifications including glycosylation, oxidation, deamidation, aspartate isomerization, and others
  • Expertise with biophysical methods for protein/mAb characterization, such as MS, CD, DSC, MFI, and light scattering
  • Ability to analyze and interpret complex data sets from multiple methodologies
  • Experience/knowledge in bioprocess, formulation development and/or relevant analytical assay development.
  • Strong independent problem-solving skills and ability to apply advanced innovative scientific approaches.
  • Experience interfacing with GMP contract test laboratories and contract manufacturing organizations
  • Experience with assessment of method robustness (assay performance characterization) required to support phase appropriate method qualification
  • Familiarity with requirements for phase appropriate method validation and testing
  • Demonstrated experience in cross-functional and functional leadership roles. Demonstrated collaboration skills working cross-functionally, maintain strong stakeholder relationships, influencing direction, voicing opinion, and communicating effectively.
  • Experience in drafting, reviewing, approving, and supporting regulatory filings and responses
  • Proficient in ICH and FDA regulations and guidance.

SystImmune is a stable, well-funded biotech company with a bright future. We offer an opportunity for you to learn and grow while making significant contributions to the company's success. SystImmune offers a comprehensive benefits package including: 100% paid employee premiums for medical/dental/vision, also STD, LTD, a 401(k) plan with a 50% company match of up to 3% and a vesting schedule of only 5 years, 15 PTO days per year, sick leave, plus 11 paid holidays and MORE.

SystImmune is an Equal Opportunity Employer. Interested applicants should send their CV and cover letter to[email protected]

  • Director of Process Development

    5 days ago

    Redmond, United States SystImmune Inc. Full time

    Director of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor...

  • Senior Director of Process Development

    4 days ago

    Redmond, United States SystImmune Inc. Full time

    Senior Director of Process Development Redmond, WA Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid...

  • Director of Process Development

    7 days ago

    Redmond, Washington, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Director of Process Development

    7 days ago

    Redmond, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Director of Process Development

    1 week ago

    Redmond, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Director of Process Development

    4 days ago

    Redmond, United States SystImmune Inc. Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Director of Process Development

    7 days ago

    Redmond, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Senior Director of Process Development

    6 days ago

    Redmond, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Senior Director of Process Development

    5 days ago

    Redmond, United States SystImmune Inc. Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Senior Director of Process Development

    4 days ago

    Redmond, United States SystImmune Full time

    Located in Redmond WA, Systimmune Inc. is a bio-pharmaceutical company focused on the treatment of cancer through developing novel therapeutic multi-specific antibodies, as well as antibody-drug conjugates (ADCs). Our objective is to create biologics that work through systematic intervention on the solid tumor micro-environment, to either directly attack the...

  • Assistant Director of Development

    2 weeks ago

    Redmond, United States The Overlake School Full time

    Description ASSISTANT DIRECTOR OF DEVELOPMENT The Overlake School, Redmond, WA The Overlake School is seeking a Full-Time Assistant Director of Development to start immediately. Founded in 1967, The Overlake School is an independent, nonsectarian, coeducational, college prep day school. Each Overlake community member is committed to the school's mission to...

  • Assistant Director of Development

    3 weeks ago

    Redmond, United States The Overlake School Full time

    Job Type Full-time Description ASSISTANT DIRECTOR OF DEVELOPMENTThe Overlake School, Redmond, WA The Overlake School is seeking a Full-Time Assistant Director of Development to start immediately. Founded in 1967, The Overlake School is an independent, nonsectarian, coeducational, college prep day school. Each Overlake community member is committed to the...

  • Assistant Director of Development

    1 month ago

    Redmond, United States The Overlake School Full time

    Job Type Full-time Description ASSISTANT DIRECTOR OF DEVELOPMENTThe Overlake School, Redmond, WA The Overlake School is seeking a Full-Time Assistant Director of Development to start immediately. Founded in 1967, The Overlake School is an independent, nonsectarian, coeducational, college prep day school. Each Overlake community member is committed to the...

  • Assistant Director of Development

    2 weeks ago

    Redmond, United States CareerBuilder Full time

    Job Type Full-time Description ASSISTANT DIRECTOR OF DEVELOPMENT The Overlake School, Redmond, WA The Overlake School is seeking a Full-Time Assistant Director of Development to start immediately. Founded in 1967, The Overlake School is an independent, nonsectarian, coeducational, college prep day school. Each Overlake community member is committed to the...

  • Assistant Director of Development

    2 days ago

    Redmond, United States The Overlake School Full time

    Job Type Full-time Description ASSISTANT DIRECTOR OF DEVELOPMENT The Overlake School, Redmond, WA The Overlake School is seeking a Full-Time Assistant Director of Development to start immediately. Founded in 1967, The Overlake School is an independent, nonsectarian, coeducational, college prep day school. Each Overlake community member is committed to the...

  • Executive Director

    3 weeks ago

    Redmond, United States Opportunity Foundation of Central Oregon Full time

    Opportunity Foundation of Central Oregon is seeking a mission-driven Executive Director to join our team!Key Details:Pay: $99,000/year+Benefits: Medical, Dental, & Vision Insurance; Life & STD Insurance; Aflac; Employee Assistance Program; Generous PTO Program; Paid HolidaysLocation: 835 E Hwy 126 - Redmond, OR 97756Who We Are: Since 1965, the Opportunity...

  • Executive Director

    2 months ago

    Redmond, United States Opportunity Foundation of Central Oregon Full time

    Opportunity Foundation of Central Oregon is seeking a mission-driven Executive Director to join our team!Key Details:Pay: $99,000/year+Benefits: Medical, Dental, & Vision Insurance; Life & STD Insurance; Aflac; Employee Assistance Program; Generous PTO Program; Paid HolidaysLocation: 835 E Hwy 126 - Redmond, OR 97756Who We Are: Since 1965, the Opportunity...

  • Finance Director

    1 month ago

    Redmond, United States C&W of Washington, Inc Full time

    C&W of Washington, Inc Finance Director Redmond , Washington Apply Now Job TitleFinance DirectorJob Description SummaryDirects the Financial Control activities for a real estate services / facilities management account in a high-profile client facing leadership role. The Financial Director will be proactive member of the Account Leadership Team with direct...

  • Finance Director

    4 days ago

    Redmond, United States C&W of Washington, Inc Full time

    C&W of Washington, Inc Finance Director Redmond , Washington Apply Now Job TitleFinance DirectorJob Description SummaryDirects the Financial Control activities for a real estate services / facilities management account in a high-profile client facing leadership role. The Financial Director will be proactive member of the Account Leadership Team with direct...

  • Account Director

    1 month ago

    Redmond, United States C&W of Washington, Inc Full time

    C&W of Washington, Inc Account Director Redmond , Washington Apply Now Job TitleAccount DirectorJob Description SummaryThe Account Director is a key role in C&W with responsibility to manage the client relationship while providing exceptional client service and delivering on all aspects of the contract. The Account Director establishes the strategic...