Senior/Principal Scientist, Downstream Process Development

Absci is the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins. We translate ideas into drugs with a platform technology that reinvents the biopharmaceutical drug discovery process. We custom engineer E. coli to create novel complex biologics in their full-length format while simultaneously developing production cell lines. We are deploying cutting edge deep learning artificial intelligence to inform our designs, and every day we succeed in achieving things others have dismissed as impossible. Our collaborations with pharma and biotech partners include programs for drug candidates that range across multiple protein types and therapeutic indications. We are continually innovating and expanding the scope of our capabilities and potential impact with the hope of getting better drugs to patients at truly unprecedented speeds. We are based in Vancouver, Washington, ten minutes from Portland, Oregon within an hour of world class alpine terrain and rugged Pacific coastlines.

Job Description:

We are currently seeking a self-motivated, passionate, and accomplished Senior Scientist to join our Purification team. You will play an impactful role in downstream process development of therapeutic proteins expressed using SoluPro™, Absci’s proprietary E. coli expression platform. Leveraging your background and understanding of the modern DSP process toolbox, assay development, and high-throughput screening/chromatography technologies, you will develop and optimize purification processes to assure the final, purified material meets project deliverables. This position requires strong attention-to-detail and collaboration across multi-disciplinary teams within Absci, including Strain Construction, Fermentation, Analytical Development, and Data Science. Adding to the high-performance culture, your passion for scientific innovation, excellent technical skills, and initiative will make you successful in Absci’s brand new lab!

Responsibilities:

  • Develop downstream processes for large molecules including new biological entities and biosimilars
  • Identify key project challenges, effect creative solutions to advance project timelines
  • Operation, maintenance, and installation of instrumentation (e.g. AKTA, homogenizers, etc.)
  • Execute laboratory scale chromatography using associated instrumentation, (e.g. AKTA, FPLC, etc.), and downstream processes (e.g. buffer preparation, cell lysis/homogenization, TFF, filtration, etc.)
  • Write and review formal reports, includingSOPs and other technical documents
  • Capitalize on unique advantages of the SoluPro® host strain to innovate patentable process development and characterization technologies
  • Evaluate new technologies and implement high-throughput process development solutions

Qualifications:

  • PhD with 4+ years or MS with 6+ years of industry experience in process development
  • Industry experience developing downstream processes and performing tech transfer for biologics
  • Experience interpreting results from standard analytical techniques to assess product purity and clearance of process and product-related impurities
  • Proven expertise in statistical data analysis and Design of Experiment (DoE) applied in an industrial, biopharmaceutical environment
  • Proficient in software packages such as LIMS, ELNs (electronic lab notebooks), UNICORN, JMP, etc.
  • Can-do mind-set and the ability to adapt to change with strong communication and presentation skills
  • Passion for building a creative company culture that is collaborative, multidisciplinary, and determined to make a transformative impact to our industry
  • Demonstrated track record of working on teams cross-functionally to exceed goals

HUGE Plus (but not required):

  • Knowledge of cGMP, FDA, EMA, ICH guidances and industry standards for DSPD of biotherapeutic proteins to support clinical manufacturing
  • Expertise in statistical data analysis and Design of Experiment (DoE)
  • Experience mentoring and inspiring junior team members

We seek candidates who will dive into our creative company culture that’s collaborative, multidisciplinary, and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers, creative scientists, and data-devoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you, we invite you to join us in our quest to redefine possible.

Absci offers highly competitive salaries and benefits, including medical and dental insurance, paid time off, breakfast and lunch, and 401(k) with a generous company match. Legal authorization to work in the U.S. is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Absci offers a dog-friendly work environment – bring your pup along for the ride.

Scientist I/II, Downstream Process Development

Absci is the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins. We translate ideas into drugs with a platform technology that reinvents the biopharmaceutical drug discovery process. We custom engineer E. coli to create novel complex biologics in their full-length format while simultaneously developing production cell lines. We are deploying cutting edge deep learning artificial intelligence to inform our designs, and every day we succeed in achieving things others have dismissed as impossible. Our collaborations with pharma and biotech partners include programs for drug candidates that range across multiple protein types and therapeutic indications. We are continually innovating and expanding the scope of our capabilities and potential impact with the hope of getting better drugs to patients at truly unprecedented speeds. We are based in Vancouver, Washington, ten minutes from Portland, Oregon within an hour of world class alpine terrain and rugged Pacific coastlines.

Job Description:

We are currently seeking a self-motivated, passionate, and accomplished Scientist to join our Purification team. You will play a significant role in downstream process development of therapeutic proteins expressed using SoluPro™, Absci’s proprietary E. coli expression platform. You will leverage your background and understanding of the modern DSP process toolbox, assay development, and high-throughput screening/chromatography technologies to develop and optimize purification processes to assure the final, purified material meets project deliverables. This position requires strong attention-to-detail and collaboration across multi-disciplinary teams within Absci, including Strain Construction, Fermentation, Analytical Development, and Data Science. You work with a sense of urgency and thrive in a dynamic team in a high-performance culture. Your passion for scientific innovation, excellent technical skills, and initiative in the lab will make you successful in Absci’s brand new lab!

Responsibilities:

  • Develop downstream processes for large molecules including new biological entities and biosimilars
  • Identify key project challenges, effect creative solutions to advance project timelines
  • Operation, maintenance, and installation  of ¥ instrumentation (e.g. AKTA, homogenizers, etc.)
  • Execute laboratory scale chromatography using associated instrumentation, (e.g. AKTA, FPLC, etc.), and downstream processes (e.g. buffer preparation, cell lysis/homogenization, TFF, filtration, etc.)
  • Write and review reports, includingSOPs and other technical documents

Qualifications:

  • PhD with 1+ years, MS with 4+ years or BS with 6+ years of industry experience in process development
  • Industry experience developing downstream processes for biologics
  • Experience performing and interpreting results from standard analytical techniques to assess product purity and clearance of process and product-related impurities
  • Proficient in software packages such as LIMS, ELNs (electronic lab notebooks), UNICORN, JMP, etc.
  • Can-do mind-set and the ability to adapt to change with strong communication and presentation skills
  • Passion for building a creative company culture that is collaborative, multidisciplinary, and determined to make a transformative impact to our industry
  • Demonstrated track record of working on teams cross-functionally to exceed goals

HUGE Plus (but not required):

  • Knowledge of cGMP, FDA, EMA, ICH guidances and industry standards for DSPD of biotherapeutic proteins to support clinical manufacturing
  • Proficient in statistical data analysis and Design of Experiment (DoE)
  • Experience evaluating new technologies and implementing high-throughput process development solutions

We seek candidates who will dive into our creative company culture that’s collaborative, multidisciplinary, and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers, creative scientists, and data-devoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you, we invite you to join us in our quest to redefine possible.

Absci offers highly competitive salaries and benefits, including medical and dental insurance, paid time off, breakfast and lunch, and 401(k) with a generous company match. Legal authorization to work in the U.S. is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Absci offers a dog-friendly work environment – bring your pup along for the ride.

Scientist I/II Analytical Development (Separations or ELISA)

Absci is the drug and target discovery company harnessing deep learning and synthetic biology to expand the therapeutic potential of proteins. We translate ideas into drugs with a platform technology that reinvents the biopharmaceutical drug discovery process. We custom engineer E. coli to create novel complex biologics in their full-length format while simultaneously developing production cell lines. We are deploying cutting edge deep learning artificial intelligence to inform our designs, and every day we succeed in achieving things others have dismissed as impossible. Our collaborations with pharma and biotech partners include programs for drug candidates that range across multiple protein types and therapeutic indications. We are continually innovating and expanding the scope of our capabilities and potential impact with the hope of getting better drugs to patients at truly unprecedented speeds. We are based in Vancouver, Washington, ten minutes from Portland, Oregon within an hour of world class alpine terrain and rugged Pacific coastlines.

Job Description

We are currently seeking a self-motivated, passionate, and accomplished Scientist to join our Analytical Development team. You will play a significant role in analytical method development and characterization of therapeutic proteins expressed using SoluPro™, Absci’s proprietary E. coli expression platform. You will explore new and innovative technologies, oversee the routine instrument operation and maintenance, and train and mentor  junior personnel and personnel from other teams. The responsibilities of this role will utilize your interpersonal and strong written and verbal communication skills for multi-disciplinary collaboration with the other teams within Absci, including Strain Construction, High-Throughput Screening, Fermentation, Purification, and Data Sciences. You bring a passion for scientific innovation, excellent technical skills, and you execute your responsibilities with high attention to detail and a sense of urgency. You thrive in a team dynamic in a high-performance culture.

Responsibilities

  • Develop and execute laboratory tasks to support the development, optimization, and sample analysis of complex biologics by various chromatographic and electrophoretic separations techniques such as LC (e.g. LC-UV, SEC, IEX, etc.) and CE-SDS, including associated sample preparation techniques (e.g. desalting, sample concentration, protein denaturation or oxidation, etc.)
  • Operation, maintenance, and installation of sophisticated chromatography instrumentation (e.g. HPLC, CE, etc.)
  • Write and review formal reports, including method SOPs, reports, and other technical documents
  • Evaluate data for trends indicative of product performance, method performance, and/or analyst performance and present internally to team members and senior management
  • Evaluate new technologies and platforms
  • Use of software packages such as LIMS, ELNs (electronic lab notebooks), EMPOWER, JMP, etc.
  • Lead, mentor, and inspire junior team members
  • Support internal technical teams, including R&D, fermentation and purification process development teams
  • Maintain accurate documentation of all work in laboratory notebooks

Qualifications

  • PhD in Analytical Chemistry, Biochemistry, or related scientific discipline degree with 0 – 2 years of industry or post-doc experience, or Master’s with equivalent experience
  • Proven experience in method development, testing, and qualifications/ validations
  • Comprehensive hands-on knowledge of protein analytics and characterization, including LC (e.g. LC-UV, SEC, IEX, etc.) and CE-SDS OR knowledge of immunoassay methods for quantification, impurity detection and potency determination of protein samples, including ELISA, BLI and SPR
  • Experience in relevant sample preparation techniques including desalting, buffer exchange, proteolytic digestion, deglycosylation, reduction, alkylation, etc.
  • Experience in the operation, maintenance, and troubleshooting of associated instrumentation
  • Ability to design and execute experiments; review and interpret data
  • Excellent problem-solving and troubleshooting skills
  • Experience in using software packages such as LIMS, ELNs (electronic lab notebooks), EMPOWER, SoftMax Pro, JMP, etc., is preferred

Huge plus (but not required):

  • Post-Doc and/or industry experience
  • Previous experience with automation and high-throughput screening
  • Previous experience in the analysis of ADCs is a plus
  • Experience in using software packages such as LIMS, ELNs (electronic lab notebooks), EMPOWER, JMP, etc.

We seek candidates who will dive into our creative company culture that’s collaborative, multidisciplinary, and committed to a big vision for positive impact. We are defying conventions and innovating without boundaries. We are disrupting an industry with bold ideas and passionate pursuit of new possibilities. We are looking for original thinkers, creative scientists, and data-devoted gurus. Successful candidates will be excited to work in a dynamic environment and contribute as a key member of a project team. If this sounds good to you, we invite you to join us in our quest to redefine possible.

Absci offers highly competitive salaries and benefits, including medical and dental insurance, paid time off, breakfast and lunch, and 401(k) with a generous company match. Legal authorization to work in the U.S. is required. Absci is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person’s race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law. Absci will make reasonable accommodations for qualified individuals with known disabilities, in accordance with applicable law. Absci offers a dog-friendly work environment – bring your pup along for the ride.

Clinical Program Manager

Sparrow Pharmaceuticals is a biopharmaceutical company determined to discover, develop, and deliver innovative therapies that target toxic cortisol levels and unlock the potential of corticosteroid medicines such as prednisone. Sparrow is led by an experienced team of scientific thinkers, disruptors and entrepreneurs. We are developing novel therapies to address the key limitations of treatments for endogenous Cushing’s syndrome (Cushing’s), autonomous cortisol secretion (ACS), and polymyalgia rheumatica (PMR). Backed by world-class investors, we are prepared to take our medical products through the entire development continuum – from clinical trials through regulatory approval to commercialization.

 

Job Summary:

The incumbent will be responsible for ensuring the delivery execution of clinical studies in one or more therapeutic areas, in adherence to Good Clinical Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.

 

The Clinical Project Manager (CPM) will have demonstrated ability to oversee all operational aspects of Phase I-III clinical trials with minimal oversight to achieve a high-quality study data for the regulatory submission, commercialization and business success for Sparrow.

 

Essential Job Functions:

 

Study Management & Leadership

Ability to oversee multiple clinical studies and CRO vendors
Reports on key study performance information and cycle time metrics pertaining to time, cost and quality deliverables, e.g., study start-up metrics, enrollment, data collection timeliness, etc.
Leads the development of the clinical study plan including critical path activities and interdependencies for assigned clinical study
Provides operational input into study protocols, informed consent and amendments
Assists in the review and or development of the core study documents, plans and processes.
Proactively assesses potential risks to the study and proposes risk mitigation plans.
Provides study specific oversight of site feasibility, enrollment projections and site identification activities.
Develops and drives study timelines, milestones, site and study level budgets and accountable for providing monthly and yearly financial estimates. Responsible for tracking study budget and payments and forecasting study spend.
Reviews and approves site and vendor invoices, including investigator grants and pass-through costs.
Ensures oversight of TMF with periodic audits
Verifies that all relevant IT-systems are updated with current and accurate information (e.g., CTMS, eTMF).
Ensures compliance to regulatory and GCP, and internal processes
Plans and coordinates IMP and non-IMP supplies
Contributes to development of proactive strategies and corrective action plans as needed to address study issues
Identifies, implements, leads and manages a cross-functional Team for the duration of the study, working with management to identify team members and resolve issues and disseminates relevant information to team members in effective and timely manner.
Triages, resolves and/or escalates study issues /risk mitigations to Head of Clinical Operations
Has routine interaction with key internal and external stakeholders communicating project status, escalating issues, and troubleshooting routine inquiries
Responsible for the oversight, performance, and management of CROs and vendors to ensure compliance with quality measures and adherence to scope of work within timelines and budget at a task level. Specifically tracks operational study timelines and monitors operational performance metrics through the life of the study; Identifies issues and proposes solutions.
Responsible for ensuring that vendors provide timely input and generate documents in a timely manner and with quality.
Responsible for overseeing CRO to ensure that essential site documents are collected, and sites are initiated per study plan, enrollment is on target and mitigation plans are in place.
Coordinates, prepares for and executes meetings including but not limited to team meetings, investigator meetings and training.
Helps to ensure team and external partner(s) receive and document study specific training
Other tasks as assigned
Experience / Education

A Bachelor’s degree (life science preferred) or certification in a related allied health profession (i.e., nursing, medical or laboratory technology) from an appropriately accredited institution
7 – 8 years of increasing responsibility in industry clinical operations including at least 3 years clinical operations experience as study or program lead, and direct experience in global (ex-US) multicenter trials.
2 – 3 years of Monitoring experience preferred.

 

Knowledge / Skills / Abilities:

Knowledge of all phases of drug development: Phase I – IV global clinical trials
Extensive and comprehensive knowledge of Good Clinical Practice (GCP), Federal Regulations and International Regulations (International Harmonization Committee-ICH Regulations).
Demonstrated ability to comprehend complex scientific concepts and data. Proficient in reviewing and assessing clinical data.
Excellent interpersonal and decision-making skills. Demonstrates innovation. Possesses drive, energy, and enthusiasm to deliver the program objectives
Demonstrated project management skills including simultaneous management of multiple projects. Possesses excellent planning, time management & coordination skills.
Demonstrated ability to problem solve and use clear judgment in relation to regulatory requirements, interactions with external parties, timelines, and complex clinical programs.
Excellent written and oral communication skills.
Maintains computer literacy in appropriate software

Research Scientist/Postdoc

Nzumbe is a life sciences company focused on epigenetic dysregulation in disease development. We leverage our expertise in epigenetics to develop innovative drug discovery platforms and novel therapeutic strategies to target epigenetic changes in disease.

As a Research Scientist/Postdoc, you will be part of a small, fast-paced and dynamic team. The primary focus of this position is to work on the development and commercialization of unique therapeutic strategies and in vitro assays applicable to a variety of diseases ranging from cancer to neuropsychiatric disorders. This position seeks an individual who is a self-starter and finds reward in solving technical and intellectual problems while contributing to the advancement of technologies that have potential to yield insight into complex human disease. Beyond the competitive pay and excellent benefits, there are multiple opportunities for professional growth and advancement given the small and dynamic nature of the company.

Essential Duties and Responsibilities will include:

  • Design, perform and analyze experiments that advance technologies in the development pipeline
  • Contribute to strategic validation and development of technologies that identify and therapeutically target epigenetic factors underlying disease
  • Supervisory responsibilities for laboratory technical staff working on related projects
  • Maintain thorough and accurate lab records.
  • Contribute to progress reports, presentations, and manuscripts by gathering, organizing, and interpreting data.
  • Confer with other scientific personnel; attend seminars and technical meetings.

Essential Qualification/Skill Sets:

  • PhD in Molecular Biology, Biochemistry, Neuroscience or related area of study
  • Work experience in a scientific research laboratory
  • Drive to make meaningful contributions
  • Strong analytical ability and organizational skills
  • Accurate bench work, record keeping, data interpretation
  • Ability to set priorities, exercise discretion and independent judgment, and manage high production volume
  • Ability to work both independently and in a team environment
  • Strong verbal and writing skills

Bonus Skills/Experience:

  • Cell culture
  • Experience w/ human induced pluripotent stem cells (iPSCs) & neural progenitor cells (NPCs)
  • Molecular cloning
  • High-throughput assay development (e.g. luciferase assays)
  • Experience working with mice.

Nzumbe offers an entrepreneurial work environment. We value and reward excellence, contribution, and creativity in our efforts to achieve our mission. We strive to seek the best in people and implement innovative, effective strategies.

Nzumbe is an Equal Opportunity Employer offering an excellent compensation package that includes comprehensive benefits, and a relaxed environment that promotes personal and professional growth.

Send letter of interest and CV/resume with RESEARCH SCIENTIST in the subject line, to info@nzumbeinc.com.

Research Technician

Nzumbe is a life sciences company focused on epigenetic dysregulation in disease development. We leverage our expertise in epigenetics to develop innovative drug discovery platforms and novel therapeutic strategies to target epigenetic changes in disease.

As a Research Technician, you will be part of a small, fast-paced and dynamic team. The primary focus of this position is to work on the development and commercialization of innovative therapeutic strategies and unique in vitro assays applicable to a variety of diseases ranging from cancer to neuropsychiatric disorders. This position seeks an individual who is a self-starter and finds reward in solving technical and intellectual problems while contributing to the advancement of technologies that have potential to yield insight into complex human disease. Beyond the competitive pay and excellent benefits, there are multiple opportunities for professional growth and advancement given the small and dynamic nature of the company.

Essential Duties and Responsibilities will include:

  • Prepare laboratory reagents, chemicals, stocks, cultures and cell lines.
  • Operate laboratory instruments (e.g. centrifuges, plate readers, PCR thermal cyclers).
  • Perform chemical or biological analyses following written protocols.
  • Maintain thorough and accurate lab records.
  • Conduct routine tasks such as lab inventory and ordering.
  • Conduct experimental protocols with minimal instruction.
  • Contribute to progress reports, presentations, and manuscripts by gathering, organizing, and interpreting data.
  • Confer with other scientific personnel; attend seminars and technical meetings.

Essential Qualification/Skill Sets:

  • BS/BA in Molecular Biology, Biochemistry or related area of study
  • Work experience in a scientific research laboratory
  • Strong analytical ability and organizational skills
  • Accurate bench work, record keeping, data interpretation
  • Ability to set priorities, exercise discretion and independent judgment, and manage high production volume
  • Ability to work both independently and in a team environment
  • Strong verbal and writing skills

Bonus Skills/Experience:

  • Cell culture
  • Experience w/ human induced pluripotent stem cells (iPSCs) & neural progenitor cells (NPCs)
  • Molecular cloning
  • High-throughput assay development (e.g. luciferase assays)
  • Experience working with mice.

Nzumbe offers an entrepreneurial work environment. We value and reward excellence, contribution, and creativity in our efforts to achieve our mission. We strive to seek the best in people and implement innovative, effective strategies.

Nzumbe is an Equal Opportunity Employer offering an excellent compensation package that includes comprehensive benefits, and a relaxed environment that promotes personal and professional growth.

Send letter of interest and CV/resume with RESEARCH TECHNICIAN in the subject line, to info@nzumbeinc.com.